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Background: This study aimed to investigate the functional and anatomical outcomes of subthreshold micropulse laser (SMPL) therapy in eyes with early postoperative macular thickening after idiopathic epiretinal membrane (iERM) removal. Methods: This was a prospective and interventional study. Forty-eight eyes from 48 patients with macular edema at 1 month after iERM removal were randomly divided into two groups. Patients in the SMPL group (n = 24) received SMPL therapy while no special intervention was used for the observation group (n = 24). Baseline demographic data and clinical findings before and at 1 and 3 months after SMPL treatment or observation, including best-corrected visual acuity (BCVA) and the changes in central subfield thickness (CST) and average macular thickness (AMT), were analyzed. Results: An improvement in BCVA with a decrease in CST and AMT from baseline to the 3-month follow-ups were observed in both SMPL and observation groups. No significant difference in BCVA was observed between the SMPL group and observation group either in the 1-month (0.26 [0.15, 0.52] vs. 0.26 [0.15, 0.39], P = 0.852) or the 3-month (0.15 [0.10, 0.30] vs. 0.23 [0.15, 0.30], P = 0.329) follow-up. There was a greater reduction in CST in the SMPL group versus observation group between baseline and the 3-month follow-up (-77.8 ± 72.3 μm vs. -45.0 ± 46.9 μm, P = 0.049). The alteration in AMT did not differ between the two groups in either 1-month (-16.5 ± 20.1 μm vs. -19.7 ± 16.3 μm, P = 0.547) or 3-month (-36.9 ± 26.9 μm vs. -34.0 ± 20.1 μm, P = 0.678) follow-up. Conclusions: SMPL therapy led to a significant decrease in CST at the 3-month follow-up while did not significantly improve the visual acuity in patients with postoperative macular thickening following iERM surgery. Trial registration: The study was registered on Aug 27, 2020 (Trial Registration Number: ChiCTR 2000037227). [ABSTRACT FROM AUTHOR]

To determine the outcomes of intravenous (IV) tocilizumab (TCZ) in patients with non-infectious uveitis who failed with conventional immunomodulatory and anti-TNFα therapies. Records of seven patients with non-infectious uveitis treated with monthly IV TCZ (4–10 mg/kg) or biweekly IV TCZ (8 mg/kg) were reviewed. Outcome measures were changes in visual acuity, anterior chamber cell and flare grade, vitreous haze, central subfield thickness (CST), and fluorescein angiography (FA) score. Ten eyes of seven patients received TCZ therapy. Median age of patients was 14 (range, 7–24) years. Median duration of TCZ therapy was 15 (range, 5–32) months. Mean CST reduced from 373 ± 101.0 μm to 298.2 ± 40.3 μm. Mean FA score reduced from 12.5 ± 4.3 to 3.6 ± 2.6. One patient developed elevated liver transaminases. IV TCZ is a potentially effective and safe therapeutic option for the management of refractory non-infectious uveitis. [ABSTRACT FROM AUTHOR]

Abstract Introduction Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO); however, recurrence is a major concern. This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques (CP). Methods and analysis A prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experimental group will be treated with oral atorvastatin 20 mg daily combined with the control group treatment. If a drop of best-corrected visual acuity (BCVA) is more than five Early Treatment Diabetic Retinopathy Study (ETDRS) letters (one line) or an increment in central subfield thickness (CSFT) of 100 μm (or a 10% increment from the previous visit), intravitreal re-treatment will be performed. Outcome measurements include CSFT, BCVA, number of injections, and incidence of adverse events during the 12-month follow-up period. Differences between groups will be evaluated using Student’s t-test, and comparisons between groups will be evaluated using repeated-measures analysis of variance. Ethics and dissemination The study has been approved by the Institutional Review Board of Nanjing Lishui People’s Hospital, Nanjing, China (approval number 2023KY0418-12, dated 18 April 2023), and has been registered on chictr.org.cn. Written informed consent will be collected from each patient and the results of this trial will be submitted to a peer-reviewed journal. Trial registration Chinese Clinical Trial Registry ChiCTR2300071359. Registered on 12 May 2023.

Abstract Background This study aimed to investigate the functional and anatomical outcomes of subthreshold micropulse laser (SMPL) therapy in eyes with early postoperative macular thickening after idiopathic epiretinal membrane (iERM) removal. Methods This was a prospective and interventional study. Forty-eight eyes from 48 patients with macular edema at 1 month after iERM removal were randomly divided into two groups. Patients in the SMPL group (n = 24) received SMPL therapy while no special intervention was used for the observation group (n = 24). Baseline demographic data and clinical findings before and at 1 and 3 months after SMPL treatment or observation, including best-corrected visual acuity (BCVA) and the changes in central subfield thickness (CST) and average macular thickness (AMT), were analyzed. Results An improvement in BCVA with a decrease in CST and AMT from baseline to the 3-month follow-ups were observed in both SMPL and observation groups. No significant difference in BCVA was observed between the SMPL group and observation group either in the 1-month (0.26 [0.15, 0.52] vs. 0.26 [0.15, 0.39], P = 0.852) or the 3-month (0.15 [0.10, 0.30] vs. 0.23 [0.15, 0.30], P = 0.329) follow-up. There was a greater reduction in CST in the SMPL group versus observation group between baseline and the 3-month follow-up (-77.8 ± 72.3 μm vs. -45.0 ± 46.9 μm, P = 0.049). The alteration in AMT did not differ between the two groups in either 1-month (-16.5 ± 20.1 μm vs. -19.7 ± 16.3 μm, P = 0.547) or 3-month (-36.9 ± 26.9 μm vs. -34.0 ± 20.1 μm, P = 0.678) follow-up. Conclusions SMPL therapy led to a significant decrease in CST at the 3-month follow-up while did not significantly improve the visual acuity in patients with postoperative macular thickening following iERM surgery. Trial registration The study was registered on Aug 27, 2020 (Trial Registration Number: ChiCTR 2000037227).

Introduction: Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO); however, recurrence is a major concern. This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques (CP). Methods and analysis: A prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experimental group will be treated with oral atorvastatin 20 mg daily combined with the control group treatment. If a drop of best-corrected visual acuity (BCVA) is more than five Early Treatment Diabetic Retinopathy Study (ETDRS) letters (one line) or an increment in central subfield thickness (CSFT) of 100 μm (or a 10% increment from the previous visit), intravitreal re-treatment will be performed. Outcome measurements include CSFT, BCVA, number of injections, and incidence of adverse events during the 12-month follow-up period. Differences between groups will be evaluated using Student's t-test, and comparisons between groups will be evaluated using repeated-measures analysis of variance. Ethics and dissemination: The study has been approved by the Institutional Review Board of Nanjing Lishui People's Hospital, Nanjing, China (approval number 2023KY0418-12, dated 18 April 2023), and has been registered on chictr.org.cn. Written informed consent will be collected from each patient and the results of this trial will be submitted to a peer-reviewed journal. Trial registration: Chinese Clinical Trial Registry ChiCTR2300071359. Registered on 12 May 2023. [ABSTRACT FROM AUTHOR]

Aim: To study the incidence of central macular oedema at 4, 8 and 12 weeks following cataract surgery in diabetic retinopathy eyes. Materials and Methods: A prospective observational study was conducted over a period of 3 months to investigate the presence of centrally involved macular oedema following cataract surgery in diabetic retinopathy patients. Preoperative OCT scans were performed and patients without centrally involved macular oedema were enrolled. Subfield thickness (central, outer and inner) was measured preoperatively and at 4, 8 and 12 weeks postoperatively. The correlation between diabetic macular oedema (DME) and HbA1c, as well as random blood sugar (RBS) levels at the time of surgery, was analysed. Best-corrected visual acuity (BCVA) was assessed preoperatively and postoperatively, and fundus examinations were conducted each visit to evaluate diabetic retinopathy progression. Results: This study included 80 eyes from 44 patients. Postoperatively, central subfield thickness (CSF) increased significantly at first (14.7 μm), second (26.7 μm) and third (30.3 μm) compared to baseline. Inner subfield thickness (ISF) also increased at first (13.3 μm), second (20.6 μm) and third (24.3 μm) months, while the outer subfield thickness (OSF) showed progression from 6.7 μm to 16.6 μm from the first to third month. A statistically significant shift in DME was observed three months post-cataract surgery. There was a significant association between HbA1c levels and the development of DME, but no correlation with RBS levels. BCVA improved remarkably from preoperative mean log MAR of 0.75 to a mean log MAR of 0.1 at 3 months postoperatively. About 30% had mild non-proliferative diabetic retinopathy (NPDR) preoperatively, and in that group, 60% progressed to moderate NPDR. The status of moderate and severe NPDR remained the same postoperatively at 3 months. Of all patients who progressed to moderate NPDR, 3 cases developed non-central macular oedema, and three cases developed both central and non-central macular oedema postoperatively at 3 months. All eyes with severe NPDR resulted in DME, except for one (9.1%) eye. Conclusion: Preoperatively, 57.5% had no macular oedema, while 42.5% had non-central macular oedema. Postoperatively, 4.4% had central oedema, and 10.9% had both central and non-central oedema among those who initially had no macular oedema. Additionally, 38.2% developed oedema in both central and non-central regions among patients initially presenting with non-central macular oedema. There was also a significant statistical difference with longer duration of diabetes mellitus, severity of diabetic retinopathy and elevated HbA1c values with the development of diabetic macular oedema postoperatively. However, larger sample sizes and longer-term follow-up are essential for assessing retinopathy progression and the incidence of DME.

Abstract Introduction We studied the correlation of central macular fluid volume (CMFV) and central subfield thickness (CST) with best-corrected visual acuity (BCVA) in treatment-naïve eyes with diabetic macular edema (DME) 1 month after anti-vascular endothelial growth factor (VEGF) therapy. Methods This retrospective cohort study investigated eyes that received anti-VEGF therapy. All participants underwent comprehensive examinations and optical coherence tomography (OCT) volume scans at baseline (M0) and 1 month after the first treatment (M1). Two deep learning models were separately developed to automatically measure the CMFV and the CST. Correlations were analyzed between the CMFV and the logMAR BCVA at M0 and logMAR BCVA at M1. The area under the receiver operating characteristic curve (AUROC) of CMFV and CST for predicting eyes with BCVA $$\ge$$ ≥ 20/40 at M1 was analyzed. Results This study included 156 DME eyes from 89 patients. The median CMFV decreased from 0.272 (0.061–0.568) at M0 to 0.096 (0.018–0.307) mm3 at M1. The CST decreased from 414 (293–575) to 322 (252–430) μm. The logMAR BCVA decreased from 0.523 (0.301–0.817) to 0.398 (0.222–0.699). Multivariate analysis demonstrated that the CMFV was the only significant factor for logMAR BCVA at both M0 (β = 0.199, p = 0.047) and M1 (β = 0.279, p = 0.004). The AUROC of CMFV for predicting eyes with BCVA $$\ge$$ ≥ 20/40 at M1 was 0.72, and the AUROC of CST was 0.69. Conclusions Anti-VEGF therapy is an effective treatment for DME. Automated measured CMFV is a more accurate prognostic factor than CST for the initial anti-VEGF treatment outcome of DME.

Abstract Background Several optical coherence tomography (OCT) biomarkers have been proposed as predictors for functional and anatomical outcomes in Diabetic Macular Edema (DME). This study aims to examine the impact of these OCT features on the visual acuity improvement of patients with DME after long-acting Dexamethasone intravitreal implants (DEX-I) injection. Furthermore, the safety and impact of DEX-I on clinical parameters, including intraocular pressure (IOP) were assessed. Methods In this retrospective observational study, we reviewed the medical records of naïve and non-naïve eyes with DME who received at least one DEX-I. The primary endpoint was visual acuity improvement of ≥ 5 ETDRS letters at 1 month and 4 months after treatment. Secondary outcomes were the changes in OCT biomarkers and the impact of DEX-I on IOP at 1 and 4 months of follow-up. Linear panel regression analysis was used to test for differences in central subfield thickness (CST) over time and it was stratified according to biomarkers at baseline. Finally, a logistic regression analysis was used to identify factors predicting visual improvement at 1 and 4 months. Results We included 33 eyes of which 63.6% were at an advanced stage of DME. Overall, CST, cube average thickness (CAT), cube volume (CV), and intraretinal cystoid spaces > 200 μm (ICS) decreased following DEX-I injection (p

Introduction: We studied the correlation of central macular fluid volume (CMFV) and central subfield thickness (CST) with best-corrected visual acuity (BCVA) in treatment-naïve eyes with diabetic macular edema (DME) 1 month after anti-vascular endothelial growth factor (VEGF) therapy. Methods: This retrospective cohort study investigated eyes that received anti-VEGF therapy. All participants underwent comprehensive examinations and optical coherence tomography (OCT) volume scans at baseline (M0) and 1 month after the first treatment (M1). Two deep learning models were separately developed to automatically measure the CMFV and the CST. Correlations were analyzed between the CMFV and the logMAR BCVA at M0 and logMAR BCVA at M1. The area under the receiver operating characteristic curve (AUROC) of CMFV and CST for predicting eyes with BCVA ≥ 20/40 at M1 was analyzed. Results: This study included 156 DME eyes from 89 patients. The median CMFV decreased from 0.272 (0.061–0.568) at M0 to 0.096 (0.018–0.307) mm3 at M1. The CST decreased from 414 (293–575) to 322 (252–430) μm. The logMAR BCVA decreased from 0.523 (0.301–0.817) to 0.398 (0.222–0.699). Multivariate analysis demonstrated that the CMFV was the only significant factor for logMAR BCVA at both M0 (β = 0.199, p = 0.047) and M1 (β = 0.279, p = 0.004). The AUROC of CMFV for predicting eyes with BCVA ≥ 20/40 at M1 was 0.72, and the AUROC of CST was 0.69. Conclusions: Anti-VEGF therapy is an effective treatment for DME. Automated measured CMFV is a more accurate prognostic factor than CST for the initial anti-VEGF treatment outcome of DME. [ABSTRACT FROM AUTHOR]

Background: Several optical coherence tomography (OCT) biomarkers have been proposed as predictors for functional and anatomical outcomes in Diabetic Macular Edema (DME). This study aims to examine the impact of these OCT features on the visual acuity improvement of patients with DME after long-acting Dexamethasone intravitreal implants (DEX-I) injection. Furthermore, the safety and impact of DEX-I on clinical parameters, including intraocular pressure (IOP) were assessed. Methods: In this retrospective observational study, we reviewed the medical records of naïve and non-naïve eyes with DME who received at least one DEX-I. The primary endpoint was visual acuity improvement of ≥ 5 ETDRS letters at 1 month and 4 months after treatment. Secondary outcomes were the changes in OCT biomarkers and the impact of DEX-I on IOP at 1 and 4 months of follow-up. Linear panel regression analysis was used to test for differences in central subfield thickness (CST) over time and it was stratified according to biomarkers at baseline. Finally, a logistic regression analysis was used to identify factors predicting visual improvement at 1 and 4 months. Results: We included 33 eyes of which 63.6% were at an advanced stage of DME. Overall, CST, cube average thickness (CAT), cube volume (CV), and intraretinal cystoid spaces > 200 μm (ICS) decreased following DEX-I injection (p < 0.001). Additionally, a thicker CST at baseline was observed in eyes with better visual improvement at one month (p = 0.048). After logistic regression analysis, CST was retained as the only predictor for visual improvement at one month (p = 0.044). Furthermore, panel regression analysis identified a relation between subfoveal neuroretinal detachment (SND) at baseline and CST increase at four months. Lastly, only 15.2% of the eyes necessitated topical medication for IOP reduction, with no differences observed when stratifying between naïve and non-naïve eyes. Conclusion: Our analyses suggest that a ticker baseline CST may serve as a positive predictor of early visual improvement and SND presence at baseline may be a negative prognostic factor for CST increase 4 months after DEX-I injection. Other well-known biomarkers, such as disorganization of the inner retinal layers (DRIL) and hyperreflective foci (HF), did not demonstrate prognostic value on visual outcomes, at least within the first four months following the injection. [ABSTRACT FROM AUTHOR]

Abstract Background A significant portion of diabetic macular edema (DME) is refractory to anti-vascular endothelial growth factor (anti-VEGF) agents. This study investigates morphological and functional outcomes to a single intravitreal bevacizumab (IVB) injection in patients with center-involving DME (ciDME) at 4–6 weeks and compares treatment responders and non-responders based on spectral domain optical coherence tomography (SD-OCT) features. Methods IRB approved observational, retrospective chart review of patients with ciDME, identified by ICD-10 code, who received IVB and underwent baseline and 4–6 weeks follow-up SD-OCT imaging between January 1, 2016 and January 19, 2021. Patients who had received previous treatment with anti-VEGF or intraocular steroids within 1 year were excluded. Variables included best-corrected visual acuity (BCVA), central subfield thickness (CST) and total macular volume (TMV). Eyes were classified as responders if CST reduction was greater than 10%. OCT scans were graded qualitatively by two masked graders using Imagivault software. Paired Student’s t-tests, Wilcoxon signed rank tests and Chi-Square tests were used for analysis. Results A total of 334 prospective subjects were identified, and after applying exclusion criteria 52 eyes from 46 patients (mean age 64.22 ± 8.12 years, 58.7% male) were included. Mean BCVA did not significantly change with treatment, 63.9 ETDRS letters (~ 20/50) at baseline and 65.9 ETDRS letters (~ 20/50) post-treatment (p = 0.07). Mean CST decreased from 466 ± 123 μm at baseline to 402 ± 86 μm post-treatment (p

Hisham M Jammal,1 Rami Al-Omari,2 Yousef Khader3 1Department of Ophthalmology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan; 2Department of Ophthalmology, Faculty of Medicine, Yarmouk University, Irbid, Jordan; 3Department of Public Health, Faculty of Medicine, Jordan University of Science and Technology, Irbid, JordanCorrespondence: Hisham M Jammal, Department of Ophthalmology, Faculty of Medicine, Jordan University of Science and Technology, PO Box 1099, Irbid, 21110, Jordan, Tel +962-2-7201000, Fax + 962-2-7095123, Email hmjammal@just.edu.joPurpose: To report normative values of macular thickness and volume by spectral-domain optical coherence tomography (SD-OCT) in the eyes of healthy Jordanian children aged 6– 16 years and assess the correlation of macular parameters with age, sex, and refractive error.Patients and Methods: This observational study included 144 eyes of 144 healthy children. All children underwent comprehensive ocular examination and cycloplegic refraction. Average macular thickness, macular volume, central subfield thickness (CST), and macular thickness for all the Early Treatment Diabetic Retinopathy Study (ETDRS) quadrants were obtained using Primus SD-OCT (Carl Zeiss Meditec).Results: The study group consisted of 68 boys and 76 girls with a mean age (SD) of 10.8 (3.0) years. The mean (SD) spherical equivalent refraction (SER) was 0.56 (1.73) diopters (range: − 4.75 to 4.75). The mean of macular average thickness was 277.2± 12.5 μm, and the mean of the central subfield thickness was 246.7± 16.8 μm. In multivariate analysis, all macular parameters except the central subfield thickness (CST) correlated positively with the SER. Boys had significantly higher CST than girls (p=0.008). None of the macular parameters were correlated with age.Conclusion: Normative data of macular thickness for healthy Jordanian children were established for sex and age groups using SD-OCT.Keywords: central subfield thickness, macular thickness, normative data, pediatric OCT, Primus OCT

Prithvi Naveen, Vijaya Sahu, Madhumallika Pathak Department of Ophthalmology, AIIMS Raipur, Raipur, Chhattisgarh, IndiaCorrespondence: Vijaya Sahu, 2D, Block 5, Singapore City, Kota, Raipur, 492099, India, Tel +91 9752679556, Email drvijayasahu77@gmail.comPurpose: To compare which imaging and biochemical biomarkers are associated with different stages of diabetic retinopathy (DR) in type 2 diabetes mellitus patients with diabetic macular edema (DME).Patients and Methods: It was a cross-sectional, observational study that included 100 patients of DME with different stages of DR. Patients were divided into two groups: Group A – DME with non-proliferative diabetic retinopathy (NPDR) and Group B - DME with proliferative diabetic retinopathy (PDR). Group A was further subdivided into three subgroups: A (1) – DME with mild NPDR, A (2) – DME with moderate NPDR, and A (3) – DME with severe NPDR. The primary outcome measure was the association of imaging and biochemical biomarkers with different stages of DR in patients with DME.Results: Out of 100 patients, Group A (1) had 1, Group A (2) 44, Group A (3) 29, and group: B had 29 patients. As Group A (1) had only one patient, we did not include it in the calculation. The overall mean age of the study population was 54.84+9.87 years, with a male preponderance (76%). The HbA1c levels, serum triglyceride level, serum cholesterol level, and microalbuminuria level showed no significant association with different stages of DR (P> 0.05). Still, we found high serum urea levels (p=0.027) in Group B patients. The optical coherence tomography (OCT)-based imaging biomarkers – central subfield thickness (CST), cystoid macular edema (CME), subretinal fluid (SRF), and hyperreflective foci (HRF) – showed no significant association with various stages of DR. The presence of diffuse retinal thickness (DRT) (p=0.04) and the epiretinal membrane (ERM) (p=0.04) showed significant association with Group B patients.Conclusion: The essential biochemical biomarkers such as serum urea levels and DRT and ERM may be considered an important imaging biomarker for the advanced stage of DR.Keywords: imaging biomarkers, biochemical biomarkers, central subfield thickness, diffuse retinal thickness, serum urea level

Background: Recalcitrant neovascular age-related macular degeneration (rnAMD) despite intensive intravitreal anti-neovascular endothelial growth factor (VEGF) treatment, can be handled by switching to another anti-VEGF agent. This first systematic review and meta-analysis presents long-term data after switching from another anti-VEGF agent to brolucizumab. Methods: Retrospective case series over two years of patients switched to brolucizumab, and a systematic review and meta-analysis of peer-reviewed studies presenting patients switched to brolucizumab. Weighted mean differences based on the random-effects models were calculated for best-corrected visual acuity (BCVA) and central subfield thickness (CST). Results: The systematic review draws on 1200 eyes switched to brolucizumab. The meta-analysis showed a clinically irrelevant decrease in BCVA after one and two months, together with significant decreases in CST for up to one year after the switch but lacking power over 2 years. Of twelve eyes (twelve patients) in our case series, five continued treatment for two years without experiencing significant changes. Conclusions: After switch to brolucizumab, a significant morphological improvement with CST reduction was shown in eyes with rnAMD. The small worsening of BCVA may be owing to the chronically active nature of rnAMD. Brolucizumab thus remains a treatment option in rnAMD despite its potential side effects. [ABSTRACT FROM AUTHOR]

Introduction: Macular edema, a common complication of uveitis, may result in vision loss. The aim of this analysis was to report integrated phase 3 trial data for triamcinolone acetonide injectable suspension for suprachoroidal use (SCS-TA) in the treatment of macular edema secondary to noninfectious uveitis using strict inclusion criteria. Methods: This analysis included patients with central subfield thickness (CST) ≥ 300 µm and best-corrected visual acuity (BCVA) of ≥ 5 and ≤ 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at both screening and baseline who received ≥ 1 study treatment in either PEACHTREE (randomized, double-masked SCS-TA or sham control) or AZALEA (open-label SCS-TA). Patients received SCS-TA 4.0 mg (0.1 ml of 40 mg/ml) or control at baseline and week 12. Results: In the SCS-TA group (n = 95), 47.4% of patients gained ≥ 15 ETDRS letters from baseline to week 24 versus 16.7% of patients in the control group (n = 60; P < 0.001). Mean change in BCVA in the SCS-TA group was 9.6 letters at week 4 and 13.9 letters at week 24. CST also improved rapidly in the SCS-TA group (mean change: − 158.4 µm at week 4), with sustained reduction throughout the study (mean change: − 163.9 µm at week 24 versus − 19.3 µm in the control group; P < 0.001). No treatment-related serious adverse events (AEs) were reported. Incidence of AEs pertaining to elevated intraocular pressure was 12.6% and 15.0% in the SCS-TA and control groups, respectively; incidence of cataract formation/worsening AEs was 7.4% and 6.7%, respectively. Conclusion: In this integrated analysis utilizing strict inclusion criteria, SCS-TA was found effective in the treatment of patients with macular edema associated with noninfectious uveitis and was generally well tolerated. Trial registration: ClinicalTrials.gov identifier: NCT02595398, NCT03097315. [ABSTRACT FROM AUTHOR]

Purpose: To identify baseline ocular and systemic factors associated with central subfield thickness (CST) fluctuations in patients with diabetic macular edema (DME) using data from Diabetic Retinopathy Clinical Research Protocols T and V. Design: Post hoc analysis of clinical trial databases. Subjects: Patients in Protocols T and V. Methods: The standard deviation (SD) of all recorded CSTs for each patient during each Protocol’s study period was calculated. The CST SD (corresponding to CST fluctuations) for each patient was analyzed against baseline ocular and systemic factors using linear regression analyses. Each Protocol was analyzed separately. Main Outcome Measures: Factors associated with CST fluctuations. Results: A total of 1197 eyes of 1197 subjects were included. In Protocol T (559 eyes, mean CST SD was 56.4 ± 35.1 microns), using multivariate linear regression analysis, baseline urine albumin/creatine ratio (for every 1000 mg/g, CST point estimate 3.50, 95% confidence interval [CI] 0.58 to 6.43, P = 0.0190), and baseline CST (for every 10 microns, 0.87, 95% CI 0.58 to 1.16, P < 0.0001) were positively associated with CST fluctuations. Baseline visual acuity (for every 10 ETDRS letters, −9.52, 95% CI −11.89 to −7.15, P

To examine the effect of 0.1% bromfenac (BF) ophthalmic solution and 0.1% betamethasone (BM) ophthalmic solution on diabetic macular edema (DME). This was a prospective trial. Nineteen patients (mean age of 66.6 ± 10.1 years) with DME and mean retinal thickness within a diameter of 1 mm from the fovea (central subfield thickness: CST) of 250–500 µm were randomized and instilled with BF or BM. CST, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were measured at 4, 8, and 12 weeks after administration. CST at baseline (p =.128) and that at 4, 8, and 12 weeks of administration was not significantly different between the BF (10 patients) and BM groups (9 patients). In patients with glycated hemoglobin (HbA1c) <8.0%, CST, compared with baseline, was significantly decreased in the BF group (seven patients) at 8 (p =.025) and 12 weeks (p =.043) of administration. When compared with the baseline, no significant changes in BCVA were observed at any point in time in either group. Baseline IOP was comparable between the groups. In the BM group, the values of change in IOP from baseline significantly increased at 8 (p =.025) and 12 weeks (p =.044) of administration, with no significant changes in IOP over the 12 weeks of administration in the BF group. BF did not affect IOP even after 12 weeks of administration, suggesting its effect in reducing CST in DME with good glycemic control. University Hospital Medical Information Network (UMIN-CTR); UMIN000026201, February 18, 2017; Japan Registry of Clinical Trials; jRCTs031180308, March 15, 2019 [ABSTRACT FROM AUTHOR]

Purpose : Assess correlation between change in central subfield thickness (CST) and change in best-corrected visual acuity (BCVA) in eyes with macular edema due to retinal vein occlusion (RVO) that received intravitreal aflibercept injections (IAI). Methods: Post hoc analysis of COPERNICUS and GALILEO trials for CRVO and VIBRANT trial for BRVO with relationships determined using Pearson correlation coefficient. Results: In COPERNICUS, correlations (r) between change in CST and change in BCVA from baseline at weeks 12, 24, 52, and 100 were −0.36 (95% CI: −0.52, −0.18; P < 0.001), −0.38 (95% CI: −0.53, −0.20; P < 0.001), −0.44 (95% CI: −0.58, −0.27; P < 0.001), and −0.41 (95% CI: −0.56, −0.23; P < 0.001), respectively. CST changes accounted for only 21% of the variance in BCVA changes; every 100-µm decrease in CST was associated with a 2.1-letter increase in BCVA (P = 0.003). Similar findings were noted for GALILEO (r, −0.45 to −0.23) and VIBRANT (r, −0.36 to −0.32) trials. Conclusion: In eyes treated with IAI for macular edema due to RVO, correlation between change in CST and change in BCVA was weak to moderate. While change in CST may be helpful in determining the need for anti-VEGF therapy, these findings do not support using changes in CST as a surrogate for changes in visual acuity outcomes. [ABSTRACT FROM AUTHOR]

Background: A significant portion of diabetic macular edema (DME) is refractory to anti-vascular endothelial growth factor (anti-VEGF) agents. This study investigates morphological and functional outcomes to a single intravitreal bevacizumab (IVB) injection in patients with center-involving DME (ciDME) at 4–6 weeks and compares treatment responders and non-responders based on spectral domain optical coherence tomography (SD-OCT) features. Methods: IRB approved observational, retrospective chart review of patients with ciDME, identified by ICD-10 code, who received IVB and underwent baseline and 4–6 weeks follow-up SD-OCT imaging between January 1, 2016 and January 19, 2021. Patients who had received previous treatment with anti-VEGF or intraocular steroids within 1 year were excluded. Variables included best-corrected visual acuity (BCVA), central subfield thickness (CST) and total macular volume (TMV). Eyes were classified as responders if CST reduction was greater than 10%. OCT scans were graded qualitatively by two masked graders using Imagivault software. Paired Student's t-tests, Wilcoxon signed rank tests and Chi-Square tests were used for analysis. Results: A total of 334 prospective subjects were identified, and after applying exclusion criteria 52 eyes from 46 patients (mean age 64.22 ± 8.12 years, 58.7% male) were included. Mean BCVA did not significantly change with treatment, 63.9 ETDRS letters (~ 20/50) at baseline and 65.9 ETDRS letters (~ 20/50) post-treatment (p = 0.07). Mean CST decreased from 466 ± 123 μm at baseline to 402 ± 86 μm post-treatment (p < 0.001). 22 (42.3%) of eyes were categorized as responders and 30 (57.7%) as non-responders. Average change in CST from baseline in responders was -164 μm (p < 0.001) and + 9 μm in non-responders (p = 0.47). Vitreomacular adhesion (VMA) was more prevalent in non-responders (28.7% vs. 4.8%, p = 0.03). In addition, cyst location in the inner nuclear layer (INL) was present more frequently in responders (95.5% vs. 73.3%, p = 0.037) as was subretinal fluid (45.5% vs. 13.3%, p = 0.01). Conclusion: The short-term response to a single IVB was sub-optimal with structural but no functional improvements. Greater baseline CST, presence of INL cysts and subretinal fluid may represent factors indicative of a better treatment response. [ABSTRACT FROM AUTHOR]

Abstract Purpose To investigate the contralateral effect of extended release steroid implants on cystoid macular edema (CME). Methods Retrospective study of patients with bilateral CME receiving intravitreal injections of long-acting intravitreal corticosteroid implants in one eye. Changes in CME and central subfield thickness (CST) in the contralateral eye on optical coherence tomography (OCT) were compared to an untreated control group. The main outcome measures were the change in central subfield thickness (CST) and the change in the macular volume. Results Thirteen study patients and 14 controls were included in the study. There was no difference in the baseline LogMAR visual acuity (0.32 ± 0.35 vs 0.43 ± 0.26, p = 0.37) or the baseline central subfield thickness (341.4 ± 76.6 vs 296.5 ± 65.0 µm, p = 0.12) between groups. In the treatment group CST remained stable in 92.3% of the patients. Of the controls, CST worsened in 21.4% and remained stable in 78.6%. The mean change in CST (6.3 ± 30.3 vs. 27.5 ± 66.1 µm, p = 0.2) and the mean change in macular volume (0.08 ± 0.34 vs. -0.05 ± 0.21 mm3, P = 0.8) were not statistically different between the treatment group and control group. In the post-hoc analysis restricting the treatment group to patients who had not received intravitreal injections in the study eye within 6 months, CST decrement was not statistically significant (p = 0.11). Conclusion In this study there was no statistically significant effect on CME of contralateral intravitreal corticosteroid implants.

Introduction Diabetic macular edema (DME) is the most common and vision-threatening complication in diabetic patients with diabetic retinopathy (DR), especially in those with Type 2 diabetes mellitus. Optical coherence tomography (OCT) is a reliable tool most commonly used for assessing macular morphology and provides quantitative information on the macula. OCT also examines the outer retinal layers, which can predict visual outcomes. Thus, our study aims to identify the association of various OCT-detected DME morphological patterns with central subfield thickness (CST) and visual acuity. Materials and methods This is a cross-sectional observational study of 50 patients with DME detected on OCT who visited the Ophthalmology Department of Saveetha Medical College and Hospitals for a period of six months, from November 2023 to April 2024. A complete ocular examination, including best corrected visual acuity, scored with the logMAR scale, anterior segment examination, and fundus biomicroscopy using 90D and 78D lenses, was performed. Early Treatment of Diabetic Retinopathy Study (ETDRS) grading of DR into mild to very severe non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) was noted. Spectral-domain OCT was used to diagnose DME. The CST was measured, and DME was classified into four patterns: sponge-like retinal swelling (SLRS), cystoid macular edema (CME), subretinal fluid (SRF), and posterior hyaloid traction (PHT). Results In the present study, males represented 60%, and females represented 40%. The mean age of the patients was 58.07 ± 6.80 years, with a mean duration of diabetes of 11.91 ± 5.14 years. Of the 50 patients with 100 eyes, only 60 eyes showed DME on OCT. CME was the most common morphological pattern (37%), while the least common pattern was PHT (10%). No significant association was found between a specific morphological pattern and control of diabetes. The most common pattern observed was SLRS in moderate NPDR, CME in severe NPDR, SRF in very severe NPDR, and PHT in PDR. Very severe NPDR patients showed all patterns of DME, and the PHT pattern was observed only in very severe NPDR and PDR. The highest mean CST was observed in the very severe NPDR stage, and the least was in the moderate NPDR stage. The mean CST was highest in SRF patterns and lowest in SLRS patterns. The best mean visual acuity was observed in the SLRS pattern, while the worst mean visual acuity was observed in the SRF pattern, followed by the PHT pattern. Conclusion Our study highlights the importance of OCT in patients with diabetes, as OCT patterns of DME are critical for predicting visual outcomes in DR. Severe grades of DR are usually associated with SRF and PHT patterns. Since patients with SRF and PHT patterns have the worst visual outcomes, these patients, upon identification, need to be counseled about their poor visual prognosis. Those with less severe DR should be closely monitored and advised on effective diabetes control to prevent progression and protect their vision., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Institutional Ethics Committee, Saveetha Medical College and Hospitals issued approval 114/06/2023/IEC/SMCH. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Ramakrishnan et al.)

Introduction: Histological morphometric analysis of retinal layers has inherent limitations while processing the specimen. A new in vivo technique, optical coherence tomography (OCT), has been developed that can be used to analyze and differentiate normal and pathological retina. To do a morphometric analysis of normal macula in the adult population of India and study its variations on the grounds of sex and age. Material and Methods: One hundred (200 Eyes) healthy adult subjects (18–65 years) underwent macular cube scanning using Zeiss spectral-domain OCT (SD-OCT). Macular thickness from all nine regions of the Early Treatment Diabetic Retinopathy study map was documented for each subject. Their variations for age and sex were determined manually and automatically. Statistical analysis was done by entering into an MS Excel sheet using IBM SPSS Statistics for Windows,Version 25.0. Armonk, NY: IBM Corp. (2017). The data were also analyzed using an independent t-test and analysis of variance. Results: The mean age of the subjects was 34.2 ± 13 (range, 19–65) years. The mean Central Subfield Thickness (CST) measured automatically (foveal thickness) and manually was 239.52 ± 22.9 μm and 167.75 ± 21.94 μm, respectively, while mean macular thickness was 284.73 ± 15.7 μm and 276.76 ± 14.84 μm. Males were associated with greater foveal, central foveal thickness, and mean macular thickness than females (P < 0.0001). There was no significant correlation of CST, outer and inner ring, and mean macular thickness with increasing age (>30 years). However, with respect to gender in the inner ring (parafoveal region), all the quadrants except the inferior quadrant, CST was significantly (P < 0.0001) higher in males than females while in the outer ring (perifoveal region), it was the temporal quadrant that had statistically significant higher CST in males compared to females. Discussion and Conclusion: The results will add evidence and can serve as a normal database in morphometry of macula in Indians, created and found significantly different in already fed normal comparative data in SD-OCT machines. It will help analyze morphometry of macula and understand macular pathologies in Indian eyes. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the contralateral effect of extended release steroid implants on cystoid macular edema (CME).Methods: Retrospective study of patients with bilateral CME receiving intravitreal injections of long-acting intravitreal corticosteroid implants in one eye. Changes in CME and central subfield thickness (CST) in the contralateral eye on optical coherence tomography (OCT) were compared to an untreated control group. The main outcome measures were the change in central subfield thickness (CST) and the change in the macular volume.Results: Thirteen study patients and 14 controls were included in the study. There was no difference in the baseline LogMAR visual acuity (0.32 ± 0.35 vs 0.43 ± 0.26, p = 0.37) or the baseline central subfield thickness (341.4 ± 76.6 vs 296.5 ± 65.0 µm, p = 0.12) between groups. In the treatment group CST remained stable in 92.3% of the patients. Of the controls, CST worsened in 21.4% and remained stable in 78.6%. The mean change in CST (6.3 ± 30.3 vs. 27.5 ± 66.1 µm, p = 0.2) and the mean change in macular volume (0.08 ± 0.34 vs. -0.05 ± 0.21 mm3, P = 0.8) were not statistically different between the treatment group and control group. In the post-hoc analysis restricting the treatment group to patients who had not received intravitreal injections in the study eye within 6 months, CST decrement was not statistically significant (p = 0.11).Conclusion: In this study there was no statistically significant effect on CME of contralateral intravitreal corticosteroid implants. [ABSTRACT FROM AUTHOR]

Background: The aim was to study the association of serum total calcium, ionic calcium, and magnesium with increases in macular thickness parameters and photoreceptor ellipsoid zone (EZ) disruption in diabetic macular edema (DME). Methods: This study is a tertiary care center based observational cross-sectional study with sixty-six consecutive cases, divided into 3 groups of 22 cases each with no diabetic retinopathy (No DR), non-proliferative diabetic retinopathy (NPDR), and proliferative diabetic retinopathy (PDR) and a control group of 22 healthy controls. Best corrected visual acuity (BCVA) was measured on logMAR scale. Central subfield thickness (CST), cube average thickness (CAT), and EZ disruption were assessed using spectral-domain optical coherence tomography (SDOCT). Serum total calcium, ionic calcium, and magnesium were measured using standard protocol. Data was analyzed statistically. Results: Significant correlation was found between the increase in CST and the increase in serum total calcium and serum ionic calcium. Increase in CAT was significantly correlated with an increase in serum total calcium, serum ionic calcium, and a decrease in serum magnesium. Grades of EZ disruption and logMAR BCVA were also found to be significantly positively associated with serum total calcium and ionic calcium and negatively with serum magnesium. Conclusions: Increased levels of serum ionic calcium and decreased levels of serum magnesium are associated with an increase in macular thickness and EZ disruption in DME. [ABSTRACT FROM AUTHOR]

Clinical relevance: Optical coherence tomography biomarkers are dynamic and possibly change over time. The dynamic biomarkers may better predict improvement of final vision than those at baseline for diabetic macular oedema after treatment. Background: To investigate predictors for ellipsoid zone (EZ) dynamics and the association with visual acuity after treatment for diabetic macular oedema Methods: A total of 135 eyes from 135 patients with anti-vascular endothelial growth factor treatment for diabetic macular oedema were retrospectively enrolled in this study. EZ status was evaluated by optical coherence tomography at baseline, 1, 3, 6, and 12 months post-operatively. Macular perfusion status was analysed by fluorescein angiography. Duration of EZ disruption was quantified by giving scores from 0 to 5 based on the sum of visits with evidence of EZ disruption. Linear regression models were used to predict factors for scores of EZ disruption. Binary logistic regression was used to predict various EZ biomarkers for final visual acuity improvement. Results: Thirty of 87 eyes (34.4%) with intact EZ at baseline developed subsequent EZ disruption. For those with EZ disruption at baseline, 17 of 48 (35.4%) patients had restoration of disrupted EZ over time. Non-perfused macula was associated with both earlier development of EZ disruption and poor restoration (p < 0.001 and p = 0.011, respectively). Non-perfused macula, absence of epiretinal membrane, and EZ disruption at baseline predicted higher EZ scores (p < 0.001, p = 0.022 and p < 0.001, respectively). Higher EZ scores (p = 0.016), but not baseline EZ disruption (p = 0.56), were less likely to have improvement of final vision 5 letters or more. Conclusion: Macular perfusion status played an independent role in EZ dynamics. Duration of EZ disruption could be more predictive than baseline status for improvement of vision over 12 months. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate outcomes of intravenous (IV) tocilizumab (TCZ) in patients with pars planitis refractory to conventional immunomodulatory therapy and anti-tumor necrosis factor (TNF) alpha agents., Methods: Medical records of eight patients diagnosed with pars planitis and treated with monthly 4 or 8 mg/kg IV TCZ were reviewed. The primary objective was to initiate and sustain remission continuously for three consecutive months. Secondary outcome measures were changes in best corrected visual acuity (BCVA), degree of anterior chamber (AC) inflammation, vitreous cell, vitreous haze, presence of vitreous or pars plana exudates, peripheral vasculitis, fluorescein angiography (FA) score and central subfieldthickness (CST) on macular optical coherence tomography (OCT)., Results: Fourteen eyes of eight patients were treated with IV TCZ. Seven patients were women. The average age was 31.35 ± 16.42 years. In 6 (75%) out of 8 patients, IV TCZ, either as monotherapy or in combination with another conventional immunomodulatory agent, induced and sustained remission. The average FA score reduced from 11.15 ± 3.52 at the baseline visit to 6.50 ± 2.12 at the one-year follow-up visit (p-value < 0.05). None of the patients experienced any side effects of IV TCZ., Conclusion: IV Tocilizumab (TCZ) may represent an effective and safe treatment option for patients diagnosed with pars planitis resistant to conventional immunomodulatory therapy and anti-TNF alpha agents.

Background: The choroidal vasculature supplies the outer retina and is altered in many retinal diseases, including myopic traction maculopathy (MTM). Choroid health is typically assessed by measuring the choroidal thickness; however, this method has substantial limitations. The choroidal vascularity index (CVI) was recently introduced to provide quantitative information on the vascular flow in the choroid. This index has been evaluated in a wide range of diseases but has not been extensively used to characterize MTM., Aim: This study aimed to investigate the CVI across different stages of MTM and the influence of macular surgery on choroidal perfusion markers in different surgically resolved MTM stages., Methods: Eighteen healthy myopic eyes in the control group and forty-six MTM eyes in the surgical group were evaluated using enhanced optical coherence tomography (OCT) imaging. Binarized OCT images were processed to obtain the luminal choroidal area (LCA) and stromal choroidal area (SCA), which were used to calculate CVI in the form of a percentage ratio. CVI data were collected at baseline, one and four months postoperatively, and at the final clinical visit. MTM eyes were divided into four stages based on disease severity. The choriocapillaris flow area (CFA) and central subfield thickness (CSFT) were measured along side the CVI., Results: No significant differences were observed between the two groups at baseline, except for visual acuity ( p  < 0.0001). Surgery significantly improved vision at all postoperative time points ( p  < 0.0001). At baseline, there were no significant differences in CVI, CFA, or CSFT scores between the control and surgical groups. However, all three measurements were lower at the final visit in the surgical group ( p ≤0.0001). No significant differences were found in any of the parameters among the four stages of MTM ( p  > 0.05). Ultimately, correlation and multivariate linear regression analyses did not reveal any significant association between CVI and visual acuity., Conclusions: This study did not find significant preoperative differences in CVI between healthy myopic eyes and eyes with MTM. However, the postoperative CVI and CFA values were significantly lower than those of the control eyes. Thus, CVI may not be a good biomarker for surgical outcomes, as the correlation between CVI and visual acuity was not statistically significant.The CVI and CFA decreased after surgery, providing evidence of choroidal changes after surgical management.

Purpose: To compare the visual and anatomical outcomes between intravitreal aflibercept and ranibizumab for diabetic macular edema Methods: A total of 194 eyes from 194 patients (aflibercept n = 95, ranibizumab n = 99) were retrospectively enrolled in the study. All eyes fulfilled the key criteria including a baseline best-corrected visual acuity (BCVA) between 20 and 70 ETDRS letters, a central subfield thickness (CST) 300 µm or more. Primary outcomes were BCVA and CST at 1, 3, 6, and 12 months. Maintenance of vision was defined as visual loss of less than 5 letters over 6 to 12 months. Predictors for final visual acuity and visual maintenance were analyzed using multivariate regression models. Results: Both agents achieved comparable visual and anatomical outcomes at any time point over the course of follow-up (all p >.05). At 12 months, aflibercept group had higher proportions of visual gains 5, 10 and 15 letters or more (p =.014, p =.011, and p =.034, respectively). The mean number of injections was 5.0 ± 1.9 in ranibizumab group and 4.5 ± 1.9 in aflibercept group (p =.09). Ranibizumab predicted poor maintenance of vision (p =.009), but not the final visual acuity (univariate p =.1). Ranibizumab was more likely to have recurrence of subretinal fluid than aflibercept in 12 months after resolution of subretinal fluid at baseline (p =.016). Both aflibercept and ranibizumab had similar rates of loss to follow-up (p =.47) and occurrence of vitreous hemorrhage (p =.21). Conclusion: While both agents improved vision with resolution of edema, aflibercept maintained vision more effectively with less recurrence of subretinal fluid at 12 months in real-world settings. [ABSTRACT FROM AUTHOR]

Abstract Background ASP8232 is a potent and specific small molecule vascular adhesion protein-1 (VAP-1) inhibitor. This study evaluated the effect of ASP8232 on excess retinal thickness when given alone or in combination with ranibizumab in patients with center-involved diabetic macular edema (CI-DME). Methods This was a phase 2a, placebo and sham-injection controlled, double-masked, randomized, parallel-group clinical trial. Participants were patients with CI-DME and central subfield thickness (CST) ≥ 375 µm in the study eye as assessed by spectral domain optical coherence tomography. Eligible patients were randomized to (1) daily oral ASP8232 40 mg monotherapy; (2) combination therapy of daily oral ASP8232 40 mg and monthly intravitreal ranibizumab 0.3 mg; or (3) monthly intravitreal ranibizumab 0.3 mg monotherapy. The treatment period was 12 weeks. CST and best corrected visual acuity (BCVA) were assessed at baseline and at Weeks 2, 4, 8, 12, 16 and 24. The primary outcome was the mean percent change from baseline in excess CST at Week 12. Secondary outcomes were BCVA, safety and tolerability, and pharmacokinetic and pharmacodynamic characteristics of ASP8232. Results After 12 weeks, the mean (95% confidence interval) percent change in excess CST was 11.4% (− 15.0%, 37.8%) in the ASP8232 group, − 61.7% (− 86.1%, − 37.2%) in the ASP8232/ranibizumab group, and − 75.3% (− 94.8%, − 55.8%) in the ranibizumab group. The change from baseline in the two ranibizumab arms was statistically significant (P

Abstract Background To evaluate the association of central subfield thickness (CST) and cube average thickness (CAT) with ellipsoid zone (EZ) disruption on spectral domain optical coherence tomography (SD-OCT) in patients of diabetic retinopathy (DR). Methods Cross sectional study including consecutive patients of type 2 diabetes mellitus [without DR (No DR, n = 97); non-proliferative DR (NPDR, n = 91); proliferative DR (PDR, n = 83)] and healthy controls (n = 82) was undertaken. CST and CAT values were measured using SD-OCT. Data was analyzed using Chi square test, ANOVA and multivariate analysis. Discriminant values of CST and CAT for EZ disruption were evaluated using receiver operator characteristic curve. Area under curve (AUC) was computed. Results Mean CAT and CST values in the study subjects showed an incremental trend. Multivariate ordinal logistic regression analysis showed increase in CST (OR = 1.022, p

To evaluate the role of central subfield thickness (CST), cube average thickness (CAT), and cube volume (CV) as imaging biomarkers for severity of diabetic retinopathy within the ETDRS-based grades of retinopathy using spectral domain optical coherence tomography (SD-OCT). This study aims to evaluate the role of macular CST, CAT, and CV on SD-OCT as imaging biomarkers for severity of DR. One hundred ninety-four consecutive cases of type 2 diabetes mellitus were divided according to ETDRS classification: diabetes mellitus without retinopathy (No DR; n = 65), nonproliferative diabetic retinopathy (NPDR; n = 66), and proliferative diabetic retinopathy (PDR; n = 63). Sixty-three healthy controls were included. CST, CAT, and CV were analyzed using SD-OCT. Data were analyzed statistically. Analysis of variance revealed a significant increase in levels of CST, CAT, CV, and LogMAR visual acuity with the increase in severity of DR. Independent t-test revealed significant difference in CST, CAT, and CV between cases with DME and cases without DME. On multivariate linear regression analysis, increase in CST, CAT, and CV were found to indicate the increase in severity of DR. SD-OCT-based imaging biomarkers CST, CAT, and CV are effective tools for documenting the severity of diabetic retinopathy. These imaging biomarkers serve as significant indicators of severity of disease. [ABSTRACT FROM AUTHOR]

Purpose: To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). Methods: This is a French, 36-month, multicenter, observational cohort study. Between December 2013 and April 2015, ophthalmologists enrolled diabetic patients aged ≥18 years with DME-related visual impairment and for whom ranibizumab 0.5 mg was initiated. Here, we present the 12-month results from this cohort. The primary endpoint was the mean change in best-corrected visual acuity (BCVA); sample size calculations were based on RESTORE trial data (BCVA mean change = 6.8 letters, preci sion = 0.7 letters). Secondary endpoints included the change in central subfield thickness (CSFT), number of visits, number of injections received, and frequency of ocular and nonocular adverse events and serious adverse events. Results: Between December 2013 and April 2015, a total of 290 patients with DME were enrolled by 84 ophthalmologists; 12-month data are available for 242 patients (due to low recruitment rates, precision was recalculated for 242 evaluable patients: the precision was then of 1.0 letters). Mean age (± standard deviation) was 66.1 ± 11.0 years and 56.6% were male. The mean baseline BCVA and CSFT were 59.2 letters (95% confidence interval [CI] 57.3, 61.0) and 457 μm (95% CI: 438, 476), respectively. At month 12, the mean gain in BCVA from baseline was 7.4 letters (95% CI: 5.4, 9.4), with 36.8% of patients with BCVA > 70 letters versus 13.2% at baseline. Mean change in CSFT was −125 μm (95% CI: −146, −103). The mean number of ranibizumab injections was 5.1 ± 2.3 over an average of 10.4 ± 3.0 visits. No new safety findings were identified. Conclusions: The BOREAL study confirms the effectiveness and safety of ranibizumab for the treatment of DME-related visual impairment in routine clinical practice with fewer injections than reported in clinical trials. [ABSTRACT FROM AUTHOR]

Aflibercept and ranibizumab are novel drugs for effectively treating wet age-associated macular degeneration (AMD). In the present study, the effect of aflibercept and ranibizumab on wet AMD was compared. A total of 80 AMD patients were intravitreously treated with aflibercept (2.0 mg/dose, 40 participants) or ranibizumab (0.3 mg/dose, 40 participants). The mean visual acuity and central subfield thickness (CTS) were determined at baseline and each follow-up visit (every 4 weeks). ELISA was used to detect the expression of transforming growth factor-β1 (TGF-β1), monocyte chemoattractant protein 1 (MCP-1) and interleukin 6 (IL-6). The primary outcome was the mean change in visual acuity letter score (VAS) and CTS at 1 year. The VAS was markedly improved by 13.1 in the aflibercept group and by 11.0 in the ranibizumab group. In a subgroup of patients with an initial VAS of <69, the mean improvement in the VAS was 17.7 in the aflibercept group and 13.2 in the ranibizumab group (P<0.01). The mean CTS was markedly decreased by 141 in the aflibercept group and by 134 in the ranibizumab group. In the subgroup of patients with an initial VAS of <69, the mean CTS was decreased by 171 in the aflibercept group and by 154 in the ranibizumab group (P<0.01). However, the change of VAS and CTS was similar between the ranibizumab and aflibercept groups when the initial VAS was ≥69. No significant differences in serious adverse events were identified between the aflibercept and ranibizumab groups. The levels of TGF-β1, IL-6 and MCP-1 were decreased by the aflibercept and ranibizumab treatments. The decrease in the levels of the inflammatory factors was more obvious in patients with an initial VAS of <69 in comparison with that in patients with an initial VAS of ≥69. Negative correlations between the levels of TGF-β1, MCP-1 and IL-6 and the mean change of VAS when patients were treated with aflibercept or ranibizumab were identified among all ages. Positive correlations between the levels of TGF-β1, MCP-1 and IL-6 and the mean change of CTS were observed when the initial VAS of the patients was <69. In conclusion, the efficacy of aflibercept in treating patients with AMD was better than that of ranibizumab when the initial VAS of the patients was <69. The inhibition of inflammatory factors may be a secondary effect of aflibercept and ranibizumab treatment. The present study provides a useful reference for the clinical treatment of wet AMD (Chinese Clinical Trial Registry no. ChiCTR1800017782). [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To investigate long‐term functional and anatomical outcomes, discontinuation patterns, drug switching and rates of nonimprovement in patients treated with ranibizumab pro re nata (PRN) regimen for diabetic macular oedema (DME) according to the Danish national guidelines. Methods: Retrospective cohort study of 566 eyes in 566 patients with centre‐involved DME who started intravitreal treatment with ranibizumab between January 2011 and December 2013 in the Greater Copenhagen region. Data were retrieved from a database and patient records between January 2011 and March 2016 and analysed using mixed‐model statistics. Results: At the conclusion of follow‐up, 24.6% were in active ranibizumab follow‐up, 25.4% had switched to other intravitreal pharmacotherapy, 31.6% had been discontinued because of disease stability, 13.8% had been lost to follow‐up, 1.4% had been discontinued because of low visual acuity (VA), and 3.2% had died. At baseline, mean best‐corrected visual acuity (BCVA) and mean central subfield thickness (CST) were 64.9 (±15.0) letters and 400.2 (±120.3) μm. Mean change in BCVA and mean change in CST from baseline to 3, 12, 24, 36 and 48 months of follow‐up were +3.9, +3.5, +2.7, +1.8, +2.3 letters and −97.4, −102.6, −106.9, −105.9, −131.6 μm, respectively. Mean number of injections was 6.1 in year 1 and 1.8 in year 4. In 93 patients, drug switching to aflibercept showed no difference between the two drugs on BCVA or CST. In 79 patients, CST decreased <10% compared to baseline during the first year. Conclusion: In a single‐centre clinical setting, 566 patients treated for DME with ranibizumab according to the Danish national guidelines were followed for up to 4 years. Best‐corrected visual acuity (BCVA) outcomes are in the low end of clinical studies, but studied on a wider population and achieved with fewer injections. [ABSTRACT FROM AUTHOR]

Objectives: To compare retinal thickness before and after treatment with the fluocinolone acetonide (FAc) 190 µg intravitreal implant in people with diabetic macular edema (DME) using data from the Iluvien Clinical Evidence study in the UK (ICE-UK). Methods: For this retrospective cohort study, data on people attending any one of 13 participating ophthalmology departments and treated with FAc intravitreal implant between April 1, 2013 and April 15, 2015 were collected for 12 months prior to and at least 12 months after implantation. Cross-sectional and longitudinal patterns of central foveal thickness (CFT) were compared before and after FAc implant. Results: There were 208 people who contributed data from 233 individual eyes treated with the FAc implant. Mean age was 68.1 years and 62% were male. Median (interquartile range) CFT decreased from 462 µm (354–603 µm) at time of implant to 309 µm (222–433 µm) at 12 months post-implant (p < .001). Over the same period, a reduction of ≥10%, ≥25%, and ≥50% in CFT was observed in 113 (65%), 87 (50%), and 37 (21%) treated eyes, respectively. Eyes with a CFT of ≥400 µm at the time of implant were significantly more likely to achieve a reduction in CFT of ≥10%, ≥25%, and ≥50% at 12 months (all p < .001) compared with eyes with a CFT of <400 µm at implant. Both retinal thickness and changes in retinal thickness were loosely correlated with visual acuity. Conclusion: A marked reduction in retinal thickness was observed in people following FAc intravitreal implant for DME. The response was related to the degree of retinal thickness prior to treatment. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to compare the anatomical and functional outcomes of ranibizumab versus aflibercept for the treatment of macular edema due to central retinal vein occlusion (CRVO) in routine clinical practice. Methods: Participants in this observational study included 62 treatment-naïve patients with CRVO who received intravitreal injections of either ranibizumab or aflibercept. The demographic data, best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) characteristics were evaluated at baseline and at months 1, 2, 3, 6, 12 and 18 post-treatment. Results: At month 18, the mean BCVA of ranibizumab-treated eyes increased 7.9 letters, compared to 7.4 letters for eyes receiving aflibercept, with a similar number of injections. There was no statistically significant difference between the two groups in letters or in central subfield thickness at month 18. At the end of the follow-up, 50% of patients in the ranibizumab group and 42.9% in the aflibercept group showed complete resolution of macular edema. Conclusions: Ranibizumab and aflibercept demonstrated similar anatomical and functional outcomes over 18-month follow-up in patients with macular edema due to CRVO, with a similar number of injections. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess the effectiveness and safety of ILUVIEN ® in patients with chronic diabetic macular edema (DME) who were insufficiently responsive to prior therapies. Methods: This is a prospective, nonrandomized, multicenter, open-label, phase 4 pilot study assessing the effectiveness and safety of ILUVIEN ® involving 12 patients insufficiently responsive to available therapies. Assessments were performed at screening, baseline, week 1, and months 1, 3, 6, 9, and 12. Demographics, medical/ophthalmic history, prior laser, anti-VEGF, and steroid treatments, and lab tests were recorded at screening. A complete ophthalmic examination and SD-OCT were performed at screening and at all follow-up visits. Results: The patients showed improvements in best-corrected visual acuity (+3.7 letters), with greater improvement among pseudophakic patients (+6.8 letters) compared with phakic patients (-2.5 letters) 12 months after ILUVIEN ®. The mean central subfield thickness decrease from baseline to month 12 was statistically significant, with a rapid reduction in the first week. Regarding safety, only 2 patients showed an intraocular pressure (IOP) increase over 25 mm Hg during the study, and the rise in IOP was well managed with eye drops only. Conclusions: This prospective and pilot study suggests that ILUVIEN ® is safe and may be considered effective for chronic DME patients insufficiently responsive to other available therapies as it showed a rapid and sustained improvement of macular edema obtained after treatment with ILUVIEN ®. [ABSTRACT FROM AUTHOR]

Objectives:To compare retinal thickness before and after treatment with the fluocinolone acetonide (FAc) 190 µg intravitreal implant in people with diabetic macular edema (DME) using data from the Iluvien Clinical Evidence study in the UK (ICE-UK). Methods:For this retrospective cohort study, data on people attending any one of 13 participating ophthalmology departments and treated with FAc intravitreal implant between April 1, 2013 and April 15, 2015 were collected for 12 months prior to and at least 12 months after implantation. Cross-sectional and longitudinal patterns of central foveal thickness (CFT) were compared before and after FAc implant. Results:There were 208 people who contributed data from 233 individual eyes treated with the FAc implant. Mean age was 68.1 years and 62% were male. Median (interquartile range) CFT decreased from 462 µm (354–603 µm) at time of implant to 309 µm (222–433 µm) at 12 months post-implant (p < .001). Over the same period, a reduction of ≥10%, ≥25%, and ≥50% in CFT was observed in 113 (65%), 87 (50%), and 37 (21%) treated eyes, respectively. Eyes with a CFT of ≥400 µm at the time of implant were significantly more likely to achieve a reduction in CFT of ≥10%, ≥25%, and ≥50% at 12 months (allp < .001) compared with eyes with a CFT of <400 µm at implant. Both retinal thickness and changes in retinal thickness were loosely correlated with visual acuity. Conclusion:A marked reduction in retinal thickness was observed in people following FAc intravitreal implant for DME. The response was related to the degree of retinal thickness prior to treatment. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the functional and anatomic outcomes of faricimab treatment in patients with neovascular age-related macular degeneration (nAMD) who are unresponsive to other anti-vascular endothelial growth factor (VEGF) therapies., Methods: A retrospective interventional study was conducted on patients with refractory nAMD who were initially treated with intravitreal bevacizumab, ranibizumab, or aflibercept. These patients were switched to monthly faricimab injections. The central subfield thickness (CST), intraretinal fluid (IRF) or subretinal fluid (SRF) height, and visual acuities were compared before and after faricimab treatment., Results: A total of 13 eyes (eight right eyes and five left eyes) from 11 patients were followed for 10.4 ± 6.9 months after bevacizumab treatment and 40.3 ± 28.7 months after aflibercept treatment before switching to faricimab. The follow-up time for patients receiving a mean number of 3.7 ± 1.3 faricimab injections was 3.4 ± 1.2 months. The overall median CST was reduced by 18µm (p=0.001) from 342µm to 318µm, along with a reduction of 89µm (p=0.03) in IRF/SRF height from 97µm to 40µm. Following three consecutive injections, the CST showed a significant reduction of 21.5µm (p=0.004) from 344µm to 322.5µm, and IRF/SRF height was reduced by 89µm (p=0.03) from 104µm to 18.5µm. The intraretinal fluid size decreased and leakage stopped, as seen on fluorescein angiography. Visual acuity remained stable after switching to faricimab treatment (0.59 ± 0.45 logMAR vs 0.58 ± 0.45 logMAR, p=1)., Conclusions: Faricimab has proven to be an effective treatment for nAMD patients resistant to other anti-VEGF agents. It demonstrates significant anatomical improvement and vision preservation in this challenging patient population., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Cheng et al.)

Purpose: To evaluate the association between contrast sensitivity (CS) and central subfield thickness (CST) in diabetic macular edema (DME). Methods: This prospectively recruited, cross-sectional study included eyes with DME evaluated from November 2018 to March 2021. CST was measured using spectral-domain optical coherence tomography on the same day as CS testing. Only eyes with center-involving DME (CST >305 µm for women; >320 µm for men) were included. CS was evaluated using the quantitative CS function (qCSF) test. Outcomes included visual acuity (VA) and the following qCSF metrics: area under the log CS function, contrast acuity (CA), and CS thresholds at 1 to 18 cycles per degree (cpd). Pearson correlation and mixed-effects regression analyses were performed. Results: The cohort included 52 eyes of 43 patients. Pearson correlation analysis showed a stronger association between CST and CS thresholds at 6 cpd ( r  = -0.422, P  = 0.002) than CST and VA ( r  = 0.293, P  = 0.035). Mixed-effects univariate and multivariate regression analyses showed significant associations between CST and CA (β = -0.001, P  = .030), CS at 6 cpd (β = -0.002, P  = .008), and CS at 12 cpd (β = -0.001, P  = .049) but no significant associations between CST and VA. Among the visual function metrics, the effect size of CST was largest on CS at 6 cpd (β Standardized  = -0.37, P  = .008). Conclusions: In patients with DME, CS may be more strongly associated with CST than VA. Including CS as an adjunct visual function outcome measure in eyes with DME may prove clinically valuable., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Kim has received research support from National Eye Institute (R01EY027739), CureVac AG, and Ingenia Therapeutics and has a financial arrangement with Pykus Therapeutics. Dr. Miller is a consultant to Alcon, Allergan, Topcon, Carl Zeiss, Sunovion, and Genentech., (© The Author(s) 2023.)

Purpose To compare the effects of ketorolac 0.45% and diclofenac 0.1% on macular thickness and volume after uncomplicated cataract surgery. Methods A total of 76 eyes of 76 patients who underwent uncomplicated cataract surgery were included. Patients were treated with either diclofenac 0.1% (38 eyes) or ketorolac 0.45% (38 eyes) after surgery. The macular thickness and volume were obtained with optical coherence tomography ( OCT). Central subfield thickness ( CST, OCT 1 mm zone), total foveal thickness ( TFT, OCT 3 mm zone), total macular thickness ( TMT, OCT 6 mm zone), average macular thickness (AMT) and total macular volume ( TMV) were compared between the two study groups. Results No significant differences between groups were found in macular thickness or volume 1 month after cataract surgery. Two months after surgery, the ketorolac group had significantly lower CST, TFT, TMT and AMT than the diclofenac group (p < 0.05 for all). Additionally, 1 and 2 months after surgery, changes from preoperative values in CST (both p = 0.04), AMT (p = 0.02 and p < 0.01, respectively) and TMV (both p = 0.04) were significantly less in the ketorolac group than in the diclofenac group. Conclusions Following uncomplicated cataract surgery, topical ketorolac 0.45% was more effective than diclofenac 0.1% in preventing increases in macular thickness and volume. [ABSTRACT FROM AUTHOR]

Objective: To assess the relationship between baseline factors and time to diabetic macular edema (DME) resolution., Design: Post hoc analysis of VISTA and VIVID., Participants: Eyes with baseline central subfield thickness (CST) of ≥ 290 μm., Intervention: Eyes were treated with intravitreal aflibercept injection (IAI) 2 mg (n = 558; every 4 weeks or every 8 weeks after 5 monthly doses) or laser control (n = 274). The effect of baseline factors on the time to DME resolution (CST < 290 μm) was assessed in univariable and multivariable models and further evaluated by the Kaplan-Meier method., Main Outcome Measures: Time to and cumulative incidence of DME resolution., Results: Eyes treated with IAI had a 2.5-fold higher DME resolution rate, with median time of 33.0 weeks (95% confidence interval [CI], 28.1-40.0), compared with DME resolution not being achieved in 50% of eyes treated with laser control. Multivariable analysis demonstrated that a lower DME resolution rate was associated with a thicker baseline CST (hazard ratio [HR] [95% CI] per 100-μm CST increase, 0.79 [0.72-0.86]) and better baseline best-corrected visual acuity (BCVA) (HR [95% CI] per 5-letter increase, 0.87 [0.83-0.92]) with IAI. Tertiles of increasing CST (T1 CST ≤ 419 μm; T2 CST > 419 to ≤ 541; T3 CST > 541) were associated with longer median times to DME resolution (20.1, 39.1, and 49.1 weeks, respectively; P < 0.001 for T2 CST and T3 CST versus T1 CST ) and lower cumulative incidence of events (HR, 1.0, 0.6, and 0.6, respectively; P < 0.001 for T2 CST and T3 CST versus T1 CST ) with IAI. Tertiles of increasing BCVA (T1 BCVA ≤ 57 letters; T2 BCVA > 57 to ≤ 66; T3 BCVA >66) were associated with longer median times to DME resolution (28.4, 31.7, and 44.1 weeks, respectively; P < 0.05 for T3 BCVA versus T1 BCVA ) and lower cumulative incidence of events (HR, 1.0, 0.9, and 0.8, respectively; P < 0.05 for T3 BCVA versus T1 BCVA ) with IAI. No other baseline factor was associated with the time to DME resolution., Conclusions: The median time to DME resolution was 33 weeks among IAI-treated eyes. A thicker baseline CST and better baseline BCVA in the IAI group were associated with a longer time to and a lower rate of DME resolution., (Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the relationship between best-corrected visual acuity (BCVA) and anatomic features in patients with macular edema (ME) related to retinal vein occlusion (RVO)., Design: Post hoc analysis of 3 clinical trials, which included verified diagnoses, protocol refractions, and the assessment of OCT and fluorescein angiography (FA) images at a masked reading center., Participants: Patients diagnosed with RVO-ME., Methods: Correlation analyses were performed to determine the correlation between BCVA and macular anatomy at baseline and at 12 and 24 weeks and between changes from baseline to 12 and 24 weeks., Main Outcome Measures: The correlations between BCVA and central subfield thickness (CST), ellipsoid zone (EZ) integrity, intraretinal fluid (IRF), subretinal fluid, central leakage, and ischemia were assessed., Results: In a total of 828 eyes with RVO-ME, the mean age, BCVA, and CST at baseline was 64.7 years, 51.1 letters, and 656.9 μm, respectively. At baseline, a moderate negative correlation was observed between BCVA and CST (r = - 0.56, P < 0.001). At weeks 12 and 24, the mean BCVA of eyes with definitely abnormal (absent) EZ was statistically significantly worse than that of eyes with normal EZ. At week 12, a moderate negative correlation was observed between changes in BCVA and changes in CST (r = - 0.35, P < 0.001), with a similar degree of association noted at week 24 (r = - 0.35, P < 0.001). At weeks 12 and 24, eyes that showed any improvement in central IRF showed a greater improvement in BCVA than eyes that showed no improvement worsening (week 12: 463 eyes, 18.3 letters vs. 177 eyes, 13.0 letters, respectively, P < 0.001) and (week 24: 332 eyes, 20.2 letters vs. 131 eyes, 13.3 letters, respectively, P < 0.001). With respect to the correlation between baseline BCVA and fluorescein leakage or capillary nonperfusion, the Pearson correlation coefficients were - 0.41 (P < 0.001) and - 0.16 (P = 0.060), respectively., Conclusions: In addition to CST, there are important clinically relevant relationships between BCVA and both OCT and FA anatomic features in patients with RVO-ME., (Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To identify baseline ocular and systemic factors associated with central subfield thickness (CST) fluctuations in patients with diabetic macular edema (DME) using data from Diabetic Retinopathy Clinical Research Protocols T and V., Design: Post hoc analysis of clinical trial databases., Subjects: Patients in Protocols T and V., Methods: The standard deviation (SD) of all recorded CSTs for each patient during each Protocol's study period was calculated. The CST SD (corresponding to CST fluctuations) for each patient was analyzed against baseline ocular and systemic factors using linear regression analyses. Each Protocol was analyzed separately., Main Outcome Measures: Factors associated with CST fluctuations., Results: A total of 1197 eyes of 1197 subjects were included. In Protocol T (559 eyes, mean CST SD was 56.4 ± 35.1 microns), using multivariate linear regression analysis, baseline urine albumin/creatine ratio (for every 1000 mg/g, CST point estimate 3.50, 95% confidence interval [CI] 0.58 to 6.43, P  = 0.0190), and baseline CST (for every 10 microns, 0.87, 95% CI 0.58 to 1.16, P < 0.0001) were positively associated with CST fluctuations. Baseline visual acuity (for every 10 ETDRS letters, -9.52, 95% CI -11.89 to -7.15, P  < 0.0001) was negatively associated with CST fluctuations. In Protocol V (638 eyes, mean CST SD 36.6 ± 28.4 microns), gender (female, 2.18, 95% CI 0.30 to 4.06, P  = 0.0227), baseline CST (for every 10 microns, 2.51, 95% CI 2.21 to 2.82, P < 0.0001), systolic blood pressure (for every 1 mm of mercury, 0.11, 95% CI 0.01 to 0.21, P  = 0.0261), and observation with deferred anti-VEGF injections (5.04, 95% CI 2.51 to 7.58, P  < 0.0001) were positively associated with CST fluctuations. Type 2 diabetes (-7.37, 95% CI -13.64 to -1.11, P  = 0.0209) and prompt anti-VEGF injections (-6.51, 95% CI -9.07 to -3.96, P  < 0.0001) were negatively associated with CST fluctuations., Conclusions: Worse visual acuity at baseline, baseline renal disease, hypertension, female gender, type 1 diabetes, and delayed anti-VEGF treatment may be associated with increased CST fluctuations in patients with DME. Addressing these parameters may limit CST fluctuations and help identify patients requiring more frequent monitoring or treatment., (© 2022 by the American Academy of Ophthalmology.)

Purpose: To assess the correlation between the change in central subfield thickness (CST) and change in best-corrected visual acuity (BCVA) in eyes with diabetic macular edema (DME) treated with fixed-dosing intravitreal aflibercept injection (IAI). Methods: This post hoc analysis of the VISTA and VIVID randomized controlled clinical trials, in which 862 eyes with central-involved DME were randomly assigned to IAI 2 mg every 4 weeks (2q4; 290 eyes), IAI 2 mg every 8 weeks after 5 initial monthly doses (2q8; 286 eyes), or macular laser (286 eyes) and followed through 100 weeks. Correlations between the change in CST and change in BCVA from baseline to weeks 12, 52, and 100 were assessed using the Pearson correlation. Results: The respective correlations ( r [95% CI]) at weeks 12, 52, and 100 were -0.39 (-0.49 to -0.29), -0.27 (-0.38 to -0.15), and -0.30 (-0.41 to -0.17) in the 2q4 arm and -0.28 (-0.39 to -0.17), -0.29 (-0.41 to -0.17), and -0.33 (-0.44 to -0.20) in the 2q8 arm. Linear regression analysis of the correlation at week 100, adjusted for relevant baseline factors, showed CST changes accounted for 17% of the variance in BCVA changes; every 100-µm decrease in CST was associated with a 1.2-letter increase in BCVA ( P  = .001). Conclusions: Correlations between the change in CST and change in BCVA after 2q4 or 2q8 fixed-dosing IAI for DME were modest. Although a change in CST might be important in determining the need for antivascular endothelial growth factor for DME at follow-up, it was not a good surrogate for VA outcomes., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Drs Nanegrungsunk and Gu declare no conflict of interest. Dr S. Bressler has received grants to Johns Hopkins University School of Medicine from Bayer, Biocon, Biogen, Boehringer-Ingleheim Pharma GmbH & Co, EyePoint, Genentech (Roche), Mylan Inc, Notal Vision, Novartis, and Regeneron Pharmaceuticals Inc, and has a contract with Amgen as chair of the Data and Safety Monitoring Committee; Drs Du, Amer, and Moini are salaried employees with and have stock ownership in Regeneron Pharmaceuticals, Inc. Dr N. Bressler has received grants to Johns Hopkins University from Bayer, Biogen, Genentech (Roche), Novartis, Regeneron Pharmaceuticals, Inc, and Samsung Bioepis, and has contract with the American Medical Association as editor-in-chief of JAMA Ophthalmology., (© The Author(s) 2022.)