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Purpose: Proliferative vitreoretinopathy (PVR) is the major cause for surgical failure after primary rhegmatogenous retinal detachment (RRD). So far, no therapy has been proven to prevent PVR. Promising results for 5-fluorouracil (5-FU) and low-molecular weight heparin (LMWH) in high-risk eyes have been reported previously. The objective of this trial was to examine the effect of adjuvant intravitreal therapy with 5-FU and LMWH compared with placebo on incidence of PVR in high-risk patients with primary RRD. Design: Randomized, double-blind, controlled, multicenter, interventional trial with 1 interim analysis. Participants: Patients with RRD who were considered to be at high risk for PVR were included. Risk of PVR was assessed by noninvasive aqueous flare measurement using laser flare photometry. Methods: Patients were randomized 1:1 to verum (200 mg/ml 5-FU and 5 IU/ml dalteparin) and placebo (balanced salt solution) intravitreally applied during routine pars plana vitrectomy. Main Outcome Measures: Primary end point was the development of PVR grade CP (full-thickness retinal folds or subretinal strands in clock hours located posterior to equator) 1 or higher within 12 weeks after surgery. For grading, an end point committee assessed fundus photographs. Secondary end points included bestcorrected visual acuity and redetachment rate. A group sequential design with 1 interim analysis was applied using the O'Brien and Fleming boundaries. Proliferative vitreoretinopathy grade CP incidence was compared using a Mantel-Haenszel test stratified by surgeon. Results: A total of 325 patients in 13 German trial sites had been randomized (verum, n = 163; placebo, n = 162). In study eyes, mean laser flare was 31 +/- 26 pc/ms. No significant difference was found in PVR rate. Primary analysis in the modified intention-to-treat population results were: verum 28% vs. placebo 23% (including not assessable cases as failures); odds ratio [OR], 1.25; 95% confidence interval [CI], 0.76

Purpose: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. Methods: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. Results: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. Conclusion: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.

Purpose: To investigate the predictive value of preoperative anterior chamber aqueous flare levels measured by laser flare photometry for surgical success of idiopathic macular holes in addition to preoperative anatomic characteristics. Methods: Records of 105 consecutive eyes with full-thickness idiopathic macular holes which underwent pars plana vitrectomy with internal limiting membrane peeling and sulfur hexafluoride 20% (SF(6)20%) endotamponade were reviewed retrospectively. All patients underwent preoperative measurements of anterior chamber aqueous flare and anatomical idiopathic macular hole characteristics evaluated by optical coherence tomography: macular hole inner opening diameter, macular hole minimum linear diameter, macular hole base diameter, and macular hole height. Best-corrected visual acuity results were recorded pre- and postoperatively. Results: In 17 (16.2%) of 105 eyes primary closure of idiopathic macular hole failed, whereas in 88 eyes (83.8%) closure was achieved. Between both groups, preoperative macular hole minimum linear diameter (p = 0.001) and macular hole inner opening diameter (p = 0.006) were statistically different. Failure rates were significantly lower in eyes with macular hole minimum linear diameter < 400 mu m (7.4% vs 32.4%; p = 0.013) and preoperative macular hole minimum linear diameter showed moderate correlation with pre- and postoperative best-corrected visual acuity results (r = 0.512; p < 0.001; r = 0.612; p < 0.001). Mean anterior chamber aqueous flare of 11.5 +/- 9.9 pc/ms in eyes with anatomical closure and 11.8 +/- 6.4 pc/ms in unclosed cases was comparable (p = 0.28) and did not correlate with anatomical or functional results. Conclusion: Eyes with idiopathic macular hole > 400 mu m in size have a significantly higher failure rate following standardized pars plana vitrectomy with internal limiting membrane peeling and SF(6)20% endotamponade. Preoperative macular hole minimum linear diameter and macular hole inner

Background/aims The prospective, non-interventional ORCA module of the OCEAN study (Observation of Treatment Patterns with Lucentis in Approved Indications) evaluated the qualiy of spectral domain-optical coherence tomography (SD-OCT) image interpretation and treatment decisions by clinicians in Germany and the impact on visual outcomes over 24 months in patients with neovascular age-related macular degeneration (nAMD). Methods 2286 SD-OCT scans of 205 eyes were independently evaluated by clinicians and reading centres (RCs) regarding signs of choroidal neovascularisation (CNV) activity, including presence of intraretinal fluid, subretinal fluid, and/or increase in pigment epithelial detachments. Agreement between clinicians and RCs was calculated. Treatment decisions by clinicians and the impact on treatment outcomes were evaluated. Results CNV activity was detected by RCs on 1578 scans (69.0%) and by clinicians on 1392 scans (60.9%), with agreement in 74.9% of cases. Of the 1578 scans with RC detected CNV activity, anti-vascular endothelial growth factor injections were performed by clinicians in only 35.5% (560/1578). In 19.7% of cases (311/1578), lack of treatment was justified by patients request, termination criteria or chronic cystoid spaces without other signs for CNV activity. In 44.8% of cases (707/1578) with RC detected CNV activity, clinicians claimed no treatment was necessary despite having correctly detected CNV activity in about 2/3 of these cases. In 34% of cases with presumed undertreatment, visual acuity declined in the following visit. Conclusion Although broad agreement on CNV activity parameters was observed between clinicians and RCs, correct identification of CNV activity did not always lead to the initiation of (re-)treatment. To preserve vision over time, correct interpretation of SD-OCT scans and careful retreatment decisions are required.

Background The ORCA module of the non-interventional OCEAN study investigated the use of retinal imaging diagnostics in the clinical treatment of patients undergoing vascular endothelial growth factor (VEGF) inhibitor treatment as part of routine clinical care. This article analyzes the agreement between the diagnosis documented by the treating ophthalmologist and the evaluation of reading centers at baseline as well as the effect on the response to treatment during the course. Methods A total of 396 patients (age 75.4 years) were enrolled in which ranibizumab treatment was indicated by the treating ophthalmologist due to either diabetic macular edema (DME), neovascular age-related macular degeneration (nvAMD) or retinal venous occlusion (RVO). Over a period of 24 months, patient and examination data, treatments and interpretation of retinal imaging data by the treating ophthalmologist were systematically recorded. Furthermore, retinal imaging data were also evaluated by three reading centers. Results In 338 out of 396 (85.4%) study eyes, the baseline diagnosis of the treating ophthalmologist was confirmed by the reading centers (DME 87.5%, nvAMD 82.3%, RVO 94.9%). In 17 of the remaining 58 eyes with a discrepant diagnosis, there was at least a consensus with respect to the indications for VEGF inhibitor therapy. The differential diagnoses included a variety of different retinal diseases. During follow-up of up to 3 months, eyes with a consistent diagnosis showed a clear increase in visual acuity (6.4 versus 2.7 letters, p= 0.05) and greater decrease in central retinal thickness (-112.3 versus -24.4 mu m, p< 0.0001). Discussion The initial treatment decision for anti-VEGF therapy with consideration of the differential diagnoses can be challenging. Accurate evaluation of the clinical and imaging findings along with appropriate expertise appear to be important. The observation of superior initial response in eyes with a consensus of the diagnosis at baseline underline

Key PointsQuestionWhat are the safety and visual outcomes associated with the Argus II Retinal Prosthesis System in a postapproval cohort of patients? FindingsIn the first year of this postapproval study of 47 adults with Argus II implants, 49% experienced 51 nonserious adverse events and 26% experienced 13 serious adverse events, 9 of which were judged to be device related. On average, patients performed better on the square localization test and grating visual acuity in the implanted eye when the device was on than with it switched off. MeaningSafety and visual function outcomes in this clinical practice setting cohort of patients with Argus II implantations were consistent with previously reported results. This multicenter case series follows-up 47 patients who received the Argus II retinal prosthesis for severe to profound outer retinal degeneration to assess visual function and adverse events in the first year after implantation. ImportanceThe Argus II Retinal Prosthesis System is indicated for patients with vision loss due to severe to profound outer retinal degeneration, a group with few treatment options. ObjectivesTo collect postapproval safety and visual function data for the Argus II. Design, Setting, and ParticipantsMulticenter, postapproval clinical trial conducted at 9 sites in Germany and Italy. Data were collected from December 2, 2011, to September 30, 2017, and patients were followed-up for 12 months or longer. Patients were 25 years or older with severe to profound outer retinal degeneration, some residual light perception or the ability of the retina to respond to electrical stimulation, and a history of useful form vision and were already planning to undergo Argus II implantation. Main Outcomes and MeasuresThe primary end point of this study was the nature and rate of adverse events. Secondary end points included 3 visual function tests: square localization (SL), direction of motion, and grating visual acuity (GVA). ResultsForty-seven patients w

Background The purpose of this investigation was to analyse the ophthalmic follow-up care of former pre-term and fullterm born infants aged 4 to 10 years in the clinical practice and the comparison to the recommendations of the national ophthalmic guidelines. Methods For the prospective Wiesbaden Prematurity Study (WPS), 503 infants were examined: 239 former pre-term infants (PT) with gestational age (GA) <= 32 weeks and 264 former full-termborn infants (FT) with a GA >= 37 weeks aged 4 to 10 years. Ophthalmic examination was performed including refractive measurements and orthoptic examination. Anisometropia was defined as a difference of >= 1 D spherical equivalent. Data was assessed if an ophthalmological examination was performed after hospital discharge, and how many times the ophthalmologist was contacted within the last 12 months. Results Overall, strabismus and anisometropia were present in 18 and 10% of all PT, and in 2 and 5% of all FT infants, respectively. In infants aged 4 to 6 years, 65% of all former PT and 42% of all former FT had ophthalmological contacts within the last year ( p = 0.002). 15% of the pre-term infants with strabismus did not have an ophthalmological examination within the last year. The parents of three former pre-term infants reported that they never had an ophthalmologic examination after hospital discharge. Conclusion Two-thirds of the former pre-terminfants participated in a screening examination at the age of 4 to 6 years in the last year according to their parents, which is recommended by the guidelines for the care of former pre-term infants. There is still room for improvement to provide best ophthalmological care for this vulnerable population that have high risk for strabismus and amblyopia.

The purpose of the present study was to evaluate whether preexisting epiretinal membrane (ERM) is a significant risk factor for developing pseudophakic cystoid macular edema (PCME). Two hundred four consecutive eyes and 153 consecutive eyes without preexisting epiretinal membranes were retrospectively compared regarding PCME development following phacoemulsification with posterior chamber lens implantation. Patients with vascular retinal diseases, uveitis, trauma, neovascular macular degeneration, chronic inflammatory conditions, diabetic retinopathy, endophthalmitis, eventful cataract surgery, and combination of cataract surgery and vitrectomy during the observation period were excluded. Macular examination was performed using spectral-domain optical coherence tomography (SD-OCT) before as well as at 4, 8, 12, 16, 24, and 36 weeks after cataract surgery. Univariate and multivariate logistic regression analyses were calculated. PCME occurred in 32 of 204 eyes with preexisting ERM (15.7%), whereas 9 of 153 eyes without preexisting ERM (5.9%) developed PCME. The risk of PCME was significantly increased in eyes with ERM (p = 0.007). By multivariate logistic regression analysis, factors predictive of PCME included the history of previous pars plana vitrectomy for retinal detachment (odds ratio (OR) 3.619 [95% confidence interval (CI) 1.242 to 10.258]; p = 0.016) as well as the preexistence of ERM (OR 3.885 [95% CI 1.162 to 17.762]; p = 0.04). Preexisting ERM seems to be associated with an increased risk of PCME following cataract surgery. Therefore, this risk should be considered in surgery planning, preoperative medication, and follow-up care after surgery.

Patients with juvenile idiopathic arthritis often develop chronic anterior uveitis (JIAU). JIAU patients possess a particularly high risk for developing secondary glaucoma when inflammatory inactivity has been achieved. By using multiplex bead assay analysis, we assessed levels of pro-and anti-inflammatory cytokines, chemokines, or metalloproteinases in the aqueous humor (AH) of patients with clinically inactive JIAU with (JIAUwG) or without secondary glaucoma (JIAUwoG), or from patients with senile cataract as controls. Laser-flare photometry analysis prior to surgery showed no significant differences between JIAUwG or JIAUwoG. Compared with the control group, levels of interleukin-8, matrix metalloproteinase-2, -3, -9, serum amyloid A (SAA), transforming growth factor beta-1, -2, -3 (TGF beta-1, -2, -3), and tumor necrosis factor-alpha in the AH were significantly higher in patients with clinically inactive JIAUwG or JIAUwoG. Samples from JIAwoG patients displayed significantly higher levels of SAA (P < 0.0116) than JIAUwG patients. JIAUwG patients showed an increased level of TGF beta-2 in AH samples compared with JIAUwoG (P < 0.0009). These molecules may contribute to the clinical development of glaucoma in patients with JIAU.

Purpose The objective of this study was to investigate the relationship between visual acuity, peripapillary retinal nerve fibre layer (pRNFL), retinal thickness at the fovea and other factors with the neurologic status of former preterm children. Methods Results In this cross-sectional hospital based study in a maximum care tertiary centre, detailed anthropometric and ophthalmological data of former preterm children ranging from 4 to 10 years of age with a gestational age (GA) <= 32 weeks were assessed. Analyses of the correlation between pRNFL and foveal thickness, as well as visual acuity (VA) parameters at 4-10 years of age, with neurological development were evaluated at 2 years of age by Bayley Scales II of Infant Development, including Psychomotor Developmental Index (PDI) and Mental Developmental Index (MDI). Data were available for 106 former preterm children. Univariate analysis revealed a correlation between PDI with pRNFL thickness (B = 0.43; p = 0.013), VA (B = -29.2; p < 0.001), GA (B = 2.7; p = 0.002), retinopathy of prematurity (ROP; B = -16.3; p < 0.001) and intraventricular haemorrhages (IVH; B = -22.9; p < 0.001) but not with strabismus or foveal thickness. In the multivariable analysis, the association remained for visual acuity and IVH, but not for pRNFL thickness or ROP. Mental Developmental Index (MDI) was associated with visual acuity (B = -34.3; p = 0.001), GA (B = 2.53; p = 0.02) and IVH (B = -15.4; p = 0.02), the latter also in the multivariable analysis. Conclusion This study revealed an association between PDI at 2 years of age and lower visual acuity later in childhood. However, there was no correlation between retinal morphology and neurologic outcome in former preterm children after adjusting for several potential confounders.

PurposeThe inappropriate immune response to harmless foreign and self-antigens is a common feature of allergy, atopy and autoimmune disease. The influence of environmental factors in the initiation of autoimmunity is not well understood. It is conceivable that immune responses to allergens may also serve as a trigger of bystander immune reactions, including autoimmunity such as uveitis. Therefore, we wanted to investigate the prevalence of allergies and atopy in patients with different types of uveitis in comparison to a control cohort. MethodsIn total, 530 consecutive patients with new-onset anterior, intermediate, posterior and panuveitis were compared to a non-uveitis control cohort consisting of 1.060 consecutive new-referral patients who attended our specialized outpatient clinics for other reasons than uveitis. Allergy and atopy status as well as demographic data (age, gender and ethnicity) were obtained by standardized interviewer-assisted questionnaires. ResultsUveitis case cohort and control cohort did not differ significantly in the allergy status (p=0.910), such as the history of pollen allergy (p=0.671), history of drug allergy (p=0.920), history of food allergy (p=0.941), history of house dust mite allergy (p=0.197) or history of other allergens (p=0.593), nor in the atopy status (p=0.802), such as the history of atopic dermatitis (p=0.365), history of asthma (p=0.430) or history of allergic rhinitis (p=0.115). ConclusionsOur results argue against a substantial influence of allergies and atopy on the onset of uveitis.

Purpose: To compare the axial length and anterior segment alterations in preterm infants with and without retinopathy of prematurity with those of full-term infants. Methods: The Wiesbaden Prematurity Study investigated 503 participants of former gestational age <= 2 weeks and gestational age >= 37 weeks now being aged 4 to 10 years. This study included 485 participants in the prospective controlled cross-sectional, hospital-based study with successful Pentacam Scheimpflug imaging. Anterior segment parameters, axial length measurements, and associated factors were analyzed. Results: Corneal thickness did not differ between former preterm and full-term infants. Significant differences were found between preterm and full-term infants now aged <= 7 years for spherical equivalent, astigmatism, corneal diameter, and axial length. In preterm infants aged >= 8 years compared with full terms of the same age, we found a significant difference only in the corneal diameter. In multivariable analysis of the corneal diameter, we detected an association with birth weight and perinatal adverse events. Astigmatism correlated with birth weight and laser treatment, anterior chamber depth with birth weight, laser treatment and age at examination, and axial length with birth weight and age at examination. Conclusions: This study demonstrated altered axial length and anterior segment morphology in former preterm infants, especially in the first years of life. In addition, we observed that preterm infants seemed to catch up, so that the differences in ocular growth in terms of spherical equivalent, astigmatism, and axial length decreased within the first 8 years of life.

Objective To analyse macular retinal and choroidal layer thickness in former preterm and full-term infants and to assess associated perinatal influence factors and functional correlation. This prospective controlled, cross-sectional, hospital-based study in a tertiary center of maximum care examined former preterm infants with a gestational age (GA) ae 32 weeks and full-term neonates currently aged 4 to 10 years. We investigated data from 397 infants, analysing total foveal retinal thickness and six distinct macular retinal layer and choroidal layer measurements via spectral-domain optical coherence tomography. Multivariable linear regression analysis was performed to investigate associations of layer thickness with GA and retinopathy of prematurity (ROP). Total retinal thickness in the fovea was thicker in former preterm infants with GA ae 28 weeks and in those with GA between 29-32 weeks compared to full-term infants independently of ROP. Occurrence of ROP was also associated with increased foveal thickness. Ganglion cell layer together with inner plexiform layer (GCL+IPL) was thinner in infants with GA ae 28 weeks than in full-term infants at 1000 and 2000 mu m distance from the fovea, but no association with ROP was present. Similar results were found for the photoreceptor layer. Total foveal retinal thickness was associated with low visual function. This study identified low gestational age and ROP occurrence as main determinants for foveal thickening. Furthermore, thinned GCL+IPL measurements were associated with lower gestational age. This study highlights the prognostic value of these maturity parameters influencing retinal morphology, which may affect visual function.

Purpose The aim of the study was to investigate peripapillary retinal nerve fibre layer thickness (RNFLT) in former preterm infants and full-term neonates using spectral-domain optical coherence tomography (SD-OCT). Methods The prospective, controlled, cross-sectional, hospital-based study in a tertiary centre with maximum care examined 503 infants with a former gestational age (GA) of >= 37 and <= 32 weeks now aged between 4 and 10 years. In total, we analysed 432 participants with successful circular peripapillary RNFLT OCT measurements. Main outcome measures were RNFLT correlations to GA, birth weight, occurrence of retinopathy of prematurity (ROP), perinatal adverse events as well as functional correlation. Results Global RNFLT was thinner in infants with GA <= 28 weeks compared with infants with GA between 29 and 32 weeks (p=0.024), and to full-term neonates (p=0.007) independent of the occurrence of ROP. Multivariable analysis revealed that RNFLT was positively associated with higher birth weight and GA. Furthermore, a decrease of RNFLT was related to reduced visual function in all peripapillary sectors. Conclusions The main factors for retinal nerve fibre layer thinning are low birth weight and low GA. In addition, decreased RNFLT was associated with reduced visual function. This demonstrates that preterm infants are at high risk for peripapillary RNFL damage associated with reduced visual function.