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Purpose: To provide the long-term outcome of patients with end-stage severe ocular surface disease (OSD) consecutively treated with cultivated oral mucosal epithelial transplantation (COMET) followed by limbal-rigid contact lens (CL)-wear therapy., Design: Retrospective cohort., Methods: In 23 eyes of 18 patients with severe OSD who underwent COMET surgery between 2002 and 2019 and who were followed with limbal-rigid CL-wear therapy for at least 1 year postoperative, patient demographics, best-corrected visual acuity (BCVA, logMAR), Ocular Surface Grading Scores (OSGS), surgical indication and adverse events were reviewed. Primary and secondary outcomes were BCVA and OSGS changes at baseline and final examination, respectively., Results: This study involved 16 patients with Stevens-Johnson syndrome and 2 patients with mucous membrane pemphigoid (mean age: 59±15 years). The indications for COMET were as follows: corneal reconstruction for vision improvement (10 eyes (43.5%)), corneal reconstruction for persistent epithelial defect (4 eyes (17.4%)) and conjunctival (fornix) reconstruction for symblepharon release (9 eyes (39.1%)). The mean duration of CL-wear postsurgery was 6.4±3.9 years (range: 1.4 to 13.3 years). The mean BCVA at baseline and at final follow-up was logMAR 1.9±0.5 and 1.3±0.7, respectively (p<0.05). Compared with those at baseline, the OSGSs for symblepharon and upper and lower fornix shortening showed significant improvement at each follow-up time point post treatment initiation. No serious intraoperative or postoperative adverse events were observed., Conclusion: In patients afflicted with severe OSD, COMET combined with limbal-rigid CL-wear therapy postsurgery was found effective for vision improvement and ocular surface stabilisation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

To assess the surgical outcomes of re-excimer laser phototherapeutic keratectomy (re-PTK) for recurrent disease after initial PTK. Retrospective cohort study with historical comparison group. This study involved 56 patients who underwent re-PTK (mean follow-up period: 47.9 ± 36.2 months) at the Baptist Eye Institute, Kyoto, Japan. In all subjects, corrected-distance visual acuity (CDVA) before and after re-PTK was compared. Postoperative recurrence of corneal lesion with a decrease of CDVA of two lines or more was compared with postoperative best CDVA deemed as a significant relapse. The Kaplan-Meier method was used to compare the recurrence rate post-re-PTK with that after the initial PTK. The disease classification in the 78 eyes was heterozygous-type GCD (hetero-GCD, n = 47 eyes), homozygous-type GCD (homo-GCD, n = 13 eyes), band keratopathy (n = 7 eyes), lattice corneal dystrophy (n = 6 eyes), and other (n = 5 eyes). After re-PTK, homo-GCD recurred statistically significantly earlier than hetero-GCD (P = 0.0042). No significant difference was found in the recurrence rate for all diseases between post-re-PTK and post initial PTK (P > 0.05). Surgical outcomes after re-PTK were nearly equal to those after initial-PTK.

Purpose: To investigate the efficacy of aflibercept for the treatment of diabetic macular edema via a treat-and-extend regimen., Methods: This prospective, single-center, open-label, interventional study involved 30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm. The enrolled eyes each received a monthly intravitreal aflibercept injection until the CRT decreased below 300 μm, upon which the administration interval was extended for 1 month until the CRT once again increased to ≥300 μm. Main outcome measures were median BCVA and CRT at 6 and 12 months after initiation of treatment via last observation carried forward analysis, the median number of injections over the 12 months, and the effects on the diabetic retinopathy severity scale (DRSS) score of the patients who completed the 12-month follow-up period., Results: Of the 30 enrolled patients, 29 and 25 respectively completed the 6- and 12-month follow-up examinations. From baseline to 6 and 12 months after treatment initiation, the median BCVA (logarithm of the minimum angle of resolution) significantly improved from 0.52 to 0.30 and 0.35, respectively, and the median CRT significantly decreased from 439.5 to 268.5 and 249.0 μm, respectively. The median number of injections over the 12-month follow-up period was 6.0. Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more., Conclusions: When administered in a treat-and-extend regimen, aflibercept is an effective treatment option for diabetic macular edema., Competing Interests: This investigator-initiated research study was supported by Bayer Yakuhin, Ltd. (Osaka, Japan). Bayer Yakuhin, Ltd. had no role in the study design or execution. No other potential conflicts of interest relevant to this article were reported., (© 2020 The Korean Ophthalmological Society.)

Background: This study aimed to investigate the pre- and post-surgery reading ability in patients with idiopathic epiretinal membrane (ERM) to evaluate whether measurement of reading performance is a helpful test in addition to visual acuity (VA) as an assessment measure., Methods: This prospective observational study involved 42 eyes of 40 patients with idiopathic ERM. Best-corrected visual acuity (BCVA), reading ability, and metamorphopsia score were evaluated at baseline and at 3, 6, and 12 months post-surgery. As the outcome measure, the reading ability of each patient (i.e., overall performance) was examined with MNREAD-J, the Japanese version of the MNREAD reading acuity (RA) charts, to determine RA, critical print size (CPS), and maximum reading speed (MRS). Generally, a difference of 0.2 logMAR or more is considered a significant change in BCVA. Thus, as a subgroup analysis, we additionally evaluated the BCVA and reading ability of the patients with a BCVA difference of 0.1 logMAR or less between at baseline and at 12 months post-surgery., Results: Relative to their values at baseline, the subjects exhibited significantly improved BCVA, RA, and CPS throughout the post-surgery examination period (P < 0.001) and significantly improved MRS at 12 months post-surgery (P = 0.04). No significant change in the vertical metamorphopsia score was observed throughout the post-surgery follow-up period. However, and compared to the value at baseline, significant improvements in the horizontal metamorphopsia score were observed at 3, 6 (P < 0.05), and 12 months (P < 0.001) post-surgery. In the subgroup analysis of the 23 eyes that exhibited a BCVA improvement of 0.1 logMAR or less, the median BCVA did not change, but the median RA and CPS improved by 0.2 logMAR., Conclusions: Our findings showed that the surgical removal of ERM improves reading ability, even when the BCVA score does not improve. The measurement of reading performance appears to be a helpful test in addition to VA as a measure for assessing the surgical removal of ERM.

Purpose: To evaluate the surgical outcomes of the 27-gauge (G) vitrectomy system for the treatment of primary rhegmatogenous retinal detachment (RRD)., Methods: This retrospective consecutive series multicenter study involved a total of 410 eyes of 406 patients who underwent 3-port transconjunctival 27G pars plana vitrectomy (PPV) for RRD between November 2014 and December 2016 and who were followed for a minimum of 3 months postoperative. The main outcome measure was primary reattachment, with the secondary outcome measures being final reattachment, improvement of visual acuity (VA), intraocular pressure (IOP), intraoperative and postoperative complications, and surgery time., Results: Of the 410 treated eyes, primary reattachment was achieved in 392 (95.6%) and final reattachment was achieved in 410 (100%). In 226 eyes (55.1%) with macula-on RRD, the mean logarithm of the minimum angle of resolution (logMAR) VA improved from 0.16 ± 0.51 pre-surgery to 0.02 ± 0.14 post-surgery (P = 0.11). In 184 eyes (44.9%) with macula-off RRD, logMAR VA improved from 1.06 ± 0.77 pre-surgery to 0.26 ± 0.35 post-surgery (P < 0.001). Following surgery, the mean IOP was highest at 1 day (15.7 ± 7.0 mmHg) postoperative. In all eyes, surgery was concluded without the use of sutures or the need of conversion to a larger-gauge instrument. Although hypotony was observed in 14 (3.4%) of the 410 treated eyes at 1 day postoperative, it spontaneously resolved within 1 week without additional surgical intervention. No postoperative complications such as infectious endophthalmitis were observed throughout the follow-up period., Conclusion: Our findings show that 27G PPV is both safe and effective for the treatment of primary RRD.

A healthy corneal epithelium, which is essential for proper vision and protection from external pathogens, is continuously replenished throughout life by stem cells located at the limbus. In diseased or injured eyes, however, in which stem cells are deficient, severe ocular problems manifest themselves. These are notoriously difficult to manage and as a result the last 20 or so years has seen a number of therapeutic strategies emerge that aim to recover the ocular surface and restore vision in limbal stem cell deficient eyes. The dominant concept involves the generation of laboratory cultivated epithelial cell sheets expanded from small biopsies of the epithelial limbus (for patient or donors) or another non-corneal epithelial tissue such as the oral mucosa. Typically, cells are grown on sterilised human amniotic membrane as a substrate, which then forms part of the graft, or specially formulated plastic culture dishes from which cells sheets can be released by lowering the temperature, and thus the adherence of the plastic to the cells. Overall, clinical results are promising, as is discussed, with new cultivation methodologies and different cell lineages currently being investigated to augment the treatment options for visual disturbance caused by a corneal epithelial limbal stem cell deficiency., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

To assess the indications, outcomes and time to recurrence of phototherapeutic keratectomy (PTK) for anterior corneal pathology.This study involved 714 eyes of 477 consecutive patients (mean age: 66.0 ± 15.2 years; range: 6-101 years) who underwent PTK as the initial surgical intervention for an anterior corneal pathology. In case of each patient, the cornea treated by PTK, followed up by slit-lamp examination and corrected distance visual acuity (CDVA) testing. Main outcome measures included Slit-lamp findings (1), CDVA (2), patients' complaints (3).The mean follow-up period was 44.0 ± 38.8 months (range: 1-156 months).We treated 376 granular corneal dystrophy (GCD) eyes, 238 band keratopathy (BK) eyes, 23 epithelium attachment disorder eyes, 16 gelatinous drop-like corneal dystrophy (GDLD) eyes, 13 lattice corneal dystrophy (LCD) eyes, and 48 eyes with other corneal diseases. The CDVA significantly improved from LogMAR 0.65 ± 0.61 pre PTK to LogMAR 0.26 ± 0.39 post PTK. A 2 or more lines increase of CDVA was observed in GCD eyes (67.8%), BK eyes (49.2%), epithelium attachment disorder eyes (57.1%), GDLD eyes (87.5%), LCD eyes (76.9%), and other corneal disease eyes (60.4%). The recurrence of BK was rare. GCD recurred slowly. Epithelium attachment disorder eyes remitted simultaneously, and recurred comparatively faster.PTK was proved to be a successful therapy for all 6 corneal disease categories. Disease recurrence after PTK differed among the diseases, and surgeons should recognize the different rates of disease recurrence after PTK surgery.

Purpose: To evaluate the safety and efficacy of 27-gauge vitrectomy for various vitreoretinal disorders., Methods: In this retrospective comparative study, 163 consecutive eyes with various diseases that underwent 27-gauge pars plana vitrectomy with or without ultraspeed transformer by a single surgeon from June 2012 through December 2014 were analyzed in regard to best-corrected visual acuity, intraocular pressure, intraoperative and postoperative complications, and surgery time., Results: In 2 eyes (1.2%), peripheral retina breaks were encountered intraoperatively, yet no other complications were found in those eyes. No cases required larger-gauge vitrectomy. Mean best-corrected visual acuity improved from 20/58 (logarithm of the minimum angle of resolution, 0.46 ± 0.64) preoperatively to 20/32 (logarithm of the minimum angle of resolution, 0.20 ± 0.40) postoperatively (P < 0.001). Mean follow-up was 16.7 months (range, 6-33 months). Intraocular pressure remained stable throughout the postoperative course. Hypotony was seen in 15 eyes (9.2%) at 1-day postoperative, yet that spontaneously improved within 1 week. No case of retinal detachment or endophthalmitis was recorded. In macular surgeries, such as idiopathic epiretinal membrane and macular hole combined with cataract surgery, the mean surgery time was 32.1 ± 6.9 minutes with ultraspeed transformer (n = 38) and 37.1 ± 7.7 minutes without ultraspeed transformer (n = 40) (P = 0.004)., Conclusion: The 27-gauge pars plana vitrectomy was found to be safe and effective for treating various vitreoretinal disorders.

Stevens-Johnson syndrome (SJS) is an acute blistering disease of the skin and mucous membranes. Acute SJS leads to the acute inflammation of the ocular surface and chronic conjunctivitis. If not properly treated, it causes chronic cicatricial conjunctivitis and cicatricial lid margin abnormalities. Persistent inflammation and ulceration of the ocular surface with cicatricial complications of the lids leads to chronic ocular sequelae, ocular surface damage, and corneal scarring. The destruction of the glands that secrete the tear film leads to a severe form of dry eye that makes the management of chronic SJS difficult. The option that is routinely used for corneal visual rehabilitation, keratoplasty, is best avoided in such cases. We describe the management strategies that are most effective during the acute and chronic stages of SJS. Although treatments for acute SJS involve immunosuppressive and immunomodulatory therapies, amniotic membrane transplantation is also useful. The options for visual rehabilitation in patients with chronic SJS are undergoing radical change. We describe the existing literature regarding the management of SJS and highlight recent advances in the management of this disorder., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: To report the effectiveness, disease-specific outcomes, and safety of cultivated oral mucosal epithelial sheet transplantation (COMET), with the primary objective of visual improvement., Design: Noncomparative, retrospective, interventional case series., Participants: This study involved 46 eyes in 40 patients with complete limbal stem cell deficiency (LSCD) who underwent COMET for visual improvement. These LSCD disorders fell into the following 4 categories: Stevens-Johnson syndrome (SJS; 21 eyes), ocular cicatricial pemphigoid (OCP; 10 eyes), thermal or chemical injury (7 eyes), or other diseases (8 eyes)., Methods: Best-corrected visual acuity (BCVA) and ocular surface grading score were examined before surgery; at the 4th, 12th, and 24th postoperative week; and at the last follow-up. Data on COMET-related adverse events and postoperative management were collected. The outcomes in each disease category were evaluated separately., Main Outcome Measures: The primary outcome was the change in median logarithm of the minimum angle of resolution (logMAR) BCVA at the 24th postoperative week. The secondary outcome was the ocular surface grading score., Results: Median logMAR BCVA at baseline was 2.40 (range, 1.10 to 3.00). In SJS, logMAR BCVA improved significantly during the 24 weeks after surgery. In contrast, the BCVA in OCP was improved significantly only at the 4th postoperative week. In 6 of the 7 thermal or chemical injury cases, logMAR BCVA improved after planned penetrating keratoplasty or deep lamellar keratoplasty. Grading scores of ocular surface abnormalities improved in all categories. Of 31 patients with vision loss (logMAR BCVA, >2) at baseline, COMET produced improvement (logMAR BCVA, ≤2) in 15 patients (48%). Visual improvement was maintained with long-term follow-up (median, 28.7 months). Multivariate stepwise logistic regression analysis showed that corneal neovascularization and symblepharon were correlated significantly with logMAR BCVA improvement at the 24th postoperative week (P=0.0023 and P=0.0173, respectively). Although postoperative persistent epithelial defects and slight to moderate corneal infection occurred in the eyes of 16 and 2 patients, respectively, all were treated successfully with no eye perforation., Conclusions: Long-term visual improvement was achievable in cases of complete LSCD. Cultivated oral mucosal epithelial sheet transplantation offered substantial visual improvement even for patients with end-stage severe ocular surface disorders accompanying severe tear deficiency. Patients with corneal blindness such as SJS benefited from critical improvement of visual acuity., Financial Disclosure(s): The author(s) have no proprietary or commercial interest in anymaterials discussed in this article., (Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To investigate the relation between visual function, clinical findings, and visual symptoms in Stevens-Johnson syndrome (SJS) and to compare the results with Sjögren syndrome (SS) patients and normal subjects., Design: Cross-sectional comparative study., Methods: One hundred fifteen eyes of 59 consecutive patients with SJS and toxic epidermal necrolysis (TEN), 208 eyes of 104 healthy normal subjects, and 132 eyes of 66 SS patients were investigated in this multicenter study. All study subjects underwent tear function and ocular surface examinations, Landolt and functional visual acuity examinations, and the Japanese version of the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire)., Results: The mean ocular surface grading scores were significantly higher and the mean score of all 12 NEI VFQ subscales was significantly lower in the SJS patients compared to the SS patients and the normal subjects (P < .05). The conventional and functional logarithm of minimal angle of resolution (logMAR) visual acuities in SJS patients with minimal corneal complications were significantly higher and the mean total composite NEI VFQ scores were lower compared to SS patients. The conventional and functional logMAR visual acuities and the mean ocular surface grading scores in SJS with aqueous deficiency were significantly higher and the mean total composite NEI VFQ scores were lower compared to SS patients. Strong correlations between best-corrected logMAR functional visual acuities and either ocular surface grading scores or the composite NEI VFQ-25 scores were observed., Conclusions: The functional visual acuity examination reflects the severity of clinical ocular surface findings and vision-related quality of life more than the standard conventional visual acuity in SJS., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: To evaluate the correlation of functional visual acuity (FVA) measurement with ocular surface findings in patients with Stevens-Johnson syndrome (SJS)., Design: Prospective comparative study., Methods: Sixty-nine eyes of 38 patients with chronic SJS assessed at the Tokyo Dental College, Tokyo Medical Center, and the Kyoto Prefectural University of Medicine, Department of Ophthalmology, Kyoto, Japan, were studied. Twenty eyes of 10 normal subjects and 40 eyes of 20 patients with Sjögren syndrome (SS) were also studied. Conventional Landolt visual acuity (VA) and FVA examinations and slit-lamp examinations were performed. FVA was measured continuously by the FVA measurement system during a 30-second blink-free period in one eye. The visual maintenance ratio (VMR) was calculated as follows: VMR = [(2.7 - FVA)/(2.7 - baseline VA)], where logarithm of minimal angle of resolution values of FVA were entered into the formula and 2.7 represented the lowest visual acuity in this series. Slit-lamp examinations, Schirmer test, and fluorescein vital stainings were also performed in all subjects., Results: VMR was markedly lower in patients with SJS compared with patients with SS and controls. FVA values showed a relation with the presence of corneal opacity and vascularization., Conclusions: The FVA measurement system is not only a useful tool in the evaluation of dynamic VA changes, but also reflects the ocular surface clinical findings in SJS.

Meibomitis-related keratoconjunctivitis (MRKC) is characterized by meibomitis with corneal epithelial abnormalities, and can be divided into two types: MRKC accompanied with phlyctenular keratitis, and MRKC accompanied with keratoepitheliopathy that is similar to superficial punctate keratopathy (SPK). The purpose of this retrospective study was to investigate the characteristic features of keratoepitheliopathy and treatment outcomes for MRKC. This study involved 27 eyes of 18 MRKC patients (3 males and 15 females). National Eye Institute (NEI) scores and visual acuity were compared at pre and post treatment. All subjects were treated with a small-dose administration of clarithromycin. Keratoepitheliopathy characteristic to MRKC, yet different in appearance from SPK, was noted in 24 of the 27 eyes. Fluorescein staining revealed granular epithelial lesions generally larger than SPK that coexisted with small dark spots. In 17 eyes, keratoepitheliopathy was located within the pupillary zone, and the visual acuity in 12 eyes was less than 1.0. Our findings showed significant improvement in the NEI score in MRKC (p < 0.0001) and in visual acuity (p = 0.0157) post treatment, and the characteristic features of keratoepitheliopathy in MRKC that are often associated with decreased visual acuity were elucidated. The treatment of clarithromycin was found to be effective for MRKC with keratoepitheliopathy. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the long-term contrast sensitivity (CS) after laser in-situ keratomileusis (LASIK) for myopia.Methods: This retrospective, single-center, cohort study involved 190 eyes of 95 patients who underwent bilateral LASIK between January 2001 and October 2007. This study includes patients who underwent CS and higher-order aberration (HOA) measurements in a five-year postoperative period. For all enrolled patients, visual acuity, refractive error (RE) in diopters (D), CS at 3-, 6-, 12-, and 18-cycles per degree (cpd), and HOA in a 4 mm area of the dilated pupil were measured before surgery and 6 months, 1 year, and 5 years after it.Results: The mean RE measured before the surgery and after 6 months, 1 year, and 5 years after was -6.08 ± 2.50D, -0.26 ± 0.65D, -0.28 ± 0.65D, and -0.48 ± 0.80D, respectively. There were no clinically significant changes between preoperative results and the measures taken 6 months, 1 year, and 5 years after surgery. The slight increase in HOA had little effect on CS over the mid to long-term postoperative period.Conclusion: Our findings show that CS does not clinically change post LASIK. Although we were unable to identify the specific mechanism, we theorize that after LASIK there is a possibility for the compensation of HOA. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the surgical outcomes of the 27-gauge (G) vitrectomy system for the treatment of primary rhegmatogenous retinal detachment (RRD). Methods: This retrospective consecutive series multicenter study involved a total of 410 eyes of 406 patients who underwent 3-port transconjunctival 27G pars plana vitrectomy (PPV) for RRD between November 2014 and December 2016 and who were followed for a minimum of 3 months postoperative. The main outcome measure was primary reattachment, with the secondary outcome measures being final reattachment, improvement of visual acuity (VA), intraocular pressure (IOP), intraoperative and postoperative complications, and surgery time. Results: Of the 410 treated eyes, primary reattachment was achieved in 392 (95.6%) and final reattachment was achieved in 410 (100%). In 226 eyes (55.1%) with macula-on RRD, the mean logarithm of the minimum angle of resolution (logMAR) VA improved from 0.16 ± 0.51 pre-surgery to 0.02 ± 0.14 post-surgery (P = 0.11). In 184 eyes (44.9%) with macula-off RRD, logMAR VA improved from 1.06 ± 0.77 pre-surgery to 0.26 ± 0.35 post-surgery (P < 0.001). Following surgery, the mean IOP was highest at 1 day (15.7 ± 7.0 mmHg) postoperative. In all eyes, surgery was concluded without the use of sutures or the need of conversion to a larger-gauge instrument. Although hypotony was observed in 14 (3.4%) of the 410 treated eyes at 1 day postoperative, it spontaneously resolved within 1 week without additional surgical intervention. No postoperative complications such as infectious endophthalmitis were observed throughout the follow-up period. Conclusion: Our findings show that 27G PPV is both safe and effective for the treatment of primary RRD. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effectiveness of topical non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of cystoid macular edema (CME) post Descemet’s stripping automated endothelial keratoplasty (DSAEK).Study design: Retrospective observational studyMethods: In this study of 334 patients who underwent DSAEK at the Baptist Eye Institute, Kyoto, Japan between July 2011 and December 2015, 18 patients with postoperative CME (determined by optical coherence tomography) treated with topical NSAIDs after the onset of CME were included.Results: At CME onset, 17 of the 18 patients were treated with bromfenac eye drops and 1 was treated with nepafenac eye drops. Post initiation of treatment with topical NSAIDs, CME in 17 (94.4%) of the 18 patients improved at 1 month and all cases completely recovered within 3 months. At 12-months post initiation of treatment, 61.1% (n = 11) of patients achieved a visual acuity (VA) of 20/40 or better, and there was no significant difference of VA between the patients with or without an episode of postoperative CME (P = 0.55).Conclusion: The administration of topical NSAID eye drops was found to be effective in treating patients with CME post DSAEK. [ABSTRACT FROM AUTHOR]

In the long axial length subgroup, the percentage of eyes within ±0.50 D prediction error was significantly different between the four formulas (P = 0.011). In the low power subgroup, although the Cochran's Q test confirmed a statistically significant difference between the four IOL power formulas in the percentage of eyes within ±0.50 D prediction error (P = 0.021), McNemar's test with Bonferroni correction showed no significant difference in any two groups. [Extracted from the article]

To evaluate the efficacy and safety of a cultured human corneal endothelial cell (cHCEC) product in eyes with bullous keratopathy (BK). Combined analysis of multicenter phase II and III clinical trials. This analysis involved 15 BK eyes in the phase II trial and 12 BK eyes in the phase III trial that underwent cHCEC transplant therapy. Safety was assessed in all the cases. Efficacy was assessed in 17 cases with exclusion of the low- and medium-dose groups in the phase II trial. The primary endpoint was a corneal endothelial cell density of 1000 cells/mm2 or more at 24 weeks post-transplant, which was attained in 94.1% of the eyes (16 of 17), with a 95% CI of 71.3–99.9%. Additionally, 82.4% of the eyes (14 of 17) met the secondary endpoint of reduction in corneal thickness to less than 630 µm without corneal epithelial edema within the same time frame, with a 95% CI of 56.6–96.2%. The mean decrease in corneal thickness from baseline to 24 weeks post-transplant was −187.4 µm (95% CI, −240.2 µm to −134.5 µm). Furthermore, all the eyes exhibited improvement in best-corrected visual acuity from baseline to 24 weeks post-transplant (95% CI, 80.5–100.0%). By 24 weeks post-transplant, 88.9% of the patients (24 of 27) had experienced adverse events, which were mostly local, mild, and transient. The cHCEC product of this study reconstitutes the corneal endothelial layer with high cellular density and restores corneal thickness and improves visual acuity. [ABSTRACT FROM AUTHOR]

To report the safety and efficacy of a novel cell injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term 5-year postoperative clinical data from a first-in-humans clinical trial group. Prospective observational study. This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC injection therapy between December 2013 and December 2014. All patients underwent follow-up examinations at 1 week, 4 weeks, 12 weeks, and 24 weeks and 1 year, 2 years, 3 years, 4 years, and 5 years after surgery. Specific corneal endothelial cell parameters (i.e., corneal endothelial cell density [ECD], coefficient of variation of area, and percentage of hexagonal cells) and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure (IOP) were recorded. The primary outcome was the change in central ECD after cell injection therapy, and the secondary outcome was corneal thickness, BCVA, and IOP during the 5-year-postoperative follow-up period. At 5 years after surgery, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean ± standard deviation central corneal ECD was 1257 ± 467 cells/mm2 (range, 601–2067 cells/mm2), BCVA improved significantly in 10 treated eyes, the mean visual acuity changed from 0.876 logarithm of the minimum angle of resolution before surgery to 0.046 logarithm of the minimum angle of resolution after surgery, and no major adverse reactions directly related to the hCEC injection therapy were observed. The findings in this study confirmed the safety and efficacy of cultured hCEC injection therapy for up to 5 years after surgery. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the therapeutic benefits of limbal-supported contact lens (CL) wear in patients with ocular sequelae due to Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).Methods: This interventional study enrolled 10 chronic SJS/TEN eyes with a spectacle best-corrected visual acuity (BCVA) of between 0.01 and 0.7 that were fitted with a limbal-supported CL. At baseline and at after 3-months CL use, CL-wear BCVA and the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores were measured, and then compared. Incidence rates and severities of adverse events were also analyzed.Results: At after 3-months CL use, BCVA with the fitted CL significantly improved compared to that with spectacle correction at baseline (LogMAR: 0.76-0.15) (P = 0.0039), all NEI VFQ-25 scores improved, however, only in ocular pain and mental health showed statistically significant improvement (P = 0.0078 and 0.0039). No serious adverse events were observed during the follow-up.Conclusion: Wearing of the limbal-supported CL improved vision compared to spectacles and reduced ocular pain in patients with ocular sequelae due to SJS/TEN. [ABSTRACT FROM AUTHOR]

Purpose: To report an assessment of the two-step surgical combination of cultivated autologous oral mucosal epithelial transplantation (COMET) and penetrating keratoplasty (PKP) used to treat patients with severe limbal deficiency disorders, and to investigate the keratin expression patterns of transplanted surviving oral mucosal epithelium. Design: Observational case series. Methods: Two patients with Stevens-Johnson syndrome and chemical eye injury were treated by COMET followed, approximately six months later, by a PKP triple procedure. In the course of a mean follow-up period of 22.5 months, their clinical outcomes and the efficacy of this two-step surgical procedure were assessed. In addition, the keratin expression in corneal buttons excised during PKP were immunohistochemically examined to characterize the oral mucosal epithelium that survived ectopically on the cornea. In vivo laser confocal microscopy was used to investigate the structure of the epithelium on the corneal grafts. Results: The ocular surfaces were successfully reconstructed with cultivated autologous oral mucosal epithelial sheets and PKP. No clinical complications, such as persistent epithelial defects, rejections, or recurrence of cicatrization, were encountered. Postoperative best-corrected visual acuity was 20/125 in one patient and 20/100 in the other. The surviving oral mucosal epithelium, distinguished by its fluorescence pattern, consisted of an irregular, nonkeratinized, stratified epithelium without goblet cells. Immunohistochemical study demonstrated that K3, but not K12, was expressed in the transplanted cultivated oral mucosal epithelium that was similar to oral mucosal tissue. In vivo, the epithelial structure and cell density in the basal cell layer of the corneal grafts were similar to normal cornea. Conclusions: This study presents a two-step surgical approach to treat severely scarred ocular surfaces by means of a combination of COMET and PKP. Clinical outcomes suggest that this treatment may be beneficial for the maintenance of the reconstructed ocular surface by providing oral mucosal epithelium around the corneal graft. [Copyright &y& Elsevier]