Ophthalmology science最新文献

{"title":"CANBERRA: A Phase II Randomized Clinical Trial to Test the Therapeutic Potential of Oral Vicasinabin in Diabetic Retinopathy","authors":"Beatriz G. Armendariz PhD ,&nbsp;Ulrich F.O. Luhman PhD ,&nbsp;Brian Berger MD ,&nbsp;Jules Hernandez-Sanchez PhD ,&nbsp;Katrijn Bogman PhD ,&nbsp;Nikolaos Mitrousis PhD ,&nbsp;Martina Wollenhaupt MD ,&nbsp;David Kent MD ,&nbsp;Andreas Wenzel PhD ,&nbsp;Sascha Fauser MD, PhD","doi":"10.1016/j.xops.2024.100650","DOIUrl":"10.1016/j.xops.2024.100650","url":null,"abstract":"<div><h3>Objective</h3><div>Nonproliferative diabetic retinopathy (NPDR) is a progressive disease that can lead to blindness. Current therapies for NPDR are invasive and not extensively used or accessible until the disease progresses, pointing to the need for an early noninvasive treatment. The objective of CANBERRA was to assess the safety, tolerability, and efficacy of oral administration of vicasinabin (RG7774) on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe NPDR and good vision.</div></div><div><h3>Design</h3><div>CANBERRA was a global, multicentric randomized, double-masked, parallel-group, placebo-controlled, phase II study. The study duration was 36 months.</div></div><div><h3>Participants</h3><div>A total of 139 treatment-naïve patients with type 1 or type 2 diabetes mellitus and Diabetic Retinopathy Severity Scale (DRSS) levels of 47 or 53 in ≥1 eye were enrolled.</div></div><div><h3>Intervention</h3><div>Eligible patients were randomized 1:1:1 to 36 weeks of daily oral placebo, vicasinabin 30 mg, or vicasinabin 200 mg. Participants were followed for an additional 12 weeks.</div></div><div><h3>Main Outcome Measures</h3><div>The primary safety objective was to evaluate the safety and tolerability of vicasinabin by the frequency and severity of adverse events (AEs). The primary efficacy objective was to assess the effect of vicasinabin on the severity of DR, assessing the proportion of participants with ≥2-step improvement in DRSS from baseline at week 36 in the study eye.</div></div><div><h3>Results</h3><div>Results are presented in the following order: placebo, vicasinabin 30 mg, vicasinabin 200 mg; 47, 48, and 44 participants were enrolled. Baseline characteristics were balanced. Adherence to treatment was approximately 90%, and pharmacokinetic analysis showed dose-dependent plasma exposure to vicasinabin. The primary efficacy endpoint was not met: the percentage of participants who improved their DRSS by ≥2 steps at week 36 from baseline were 7.9, 9.5, and 5.7, without statistically significant differences. The systemic and ocular safety profiles of vicasinabin were favorable, and AEs distributed evenly across arms. Vicasinabin did not induce changes in glycemic control or any kidney function or cardiovascular parameters. Three patients in the placebo arm discontinued the study due to serious AEs not related to the drug.</div></div><div><h3>Conclusions</h3><div>At the doses tested, vicasinabin did not improve DRSS in participants with NPDR. The role of the cannabinoid system in DR remains elusive.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov identifier: NCT04265261. EUDRACT number: 2019-002067-10.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100650"},"PeriodicalIF":3.2,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11719906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142973868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Longitudinal Assessment of Structural and Functional Changes in Rod-cone Dystrophy: A 10-year Follow-up Study","authors":"Alexis Ceecee Britten-Jones BOptom (Hons), PhD ,&nbsp;Chi D. Luu BOrth (Hons), PhD ,&nbsp;Jasleen K. Jolly MSc, DPhil ,&nbsp;Carla J. Abbott BOptom, PhD ,&nbsp;Penelope J. Allen MBBS, FRANZCO ,&nbsp;Tina Lamey PhD ,&nbsp;Terri McLaren BSc ,&nbsp;Jennifer A. Thompson PhD ,&nbsp;John De Roach PhD ,&nbsp;Thomas L. Edwards PhD, FRANZCO ,&nbsp;Lauren N. Ayton BOptom, PhD","doi":"10.1016/j.xops.2024.100649","DOIUrl":"10.1016/j.xops.2024.100649","url":null,"abstract":"<div><h3>Purpose</h3><div>Emerging clinical trials for inherited retinal disease (IRD) require an understanding of long-term progression. This longitudinal study investigated the genetic diagnosis and change in retinal structure and function over 10 years in rod-cone dystrophies (RCDs).</div></div><div><h3>Design</h3><div>Longitudinal observational follow-up study.</div></div><div><h3>Participants</h3><div>Individuals initially diagnosed with retinitis pigmentosa who underwent baseline assessment between 2010 and 2013.</div></div><div><h3>Methods</h3><div>Baseline and follow-up assessments included best-corrected visual acuity (VA), Goldmann visual field (GVF) perimetry, spectral-domain OCT imaging, electroretinogram, and panel-based genetic testing. Linear mixed models were used to investigate disease progression and interaction between progression rate and baseline measurement. Interocular symmetry in disease progression was assessed using intraclass correlation coefficients (ICCs).</div></div><div><h3>Main Outcome Measures</h3><div>Change in VA, GVF area, and ellipsoid zone (EZ) width over 10 years in RCD.</div></div><div><h3>Results</h3><div>A total of 23 participants attended follow-up (mean age 63 ± 15 years at follow-up; 48% female), with 20 classified as having RCD and 3 reclassified as having cone-rod dystrophy based on genetic diagnosis. At 10-year follow-up, only 60% of RCD participants showed progression of ≥15 letters in either or both eyes, and 40% did not meet the criteria in either eye. Between the eye with poorer versus better VA at baseline, high symmetry in disease progression was observed for GVF area (ICC = 0.87; 95% confidence interval [CI]: 0.68–0.95), and moderate interocular symmetry in disease progression was observed for VA (ICC = 0.50 [95% CI: 0.07–0.77]) and EZ width (ICC = 0.64 [95% CI: 0.25–0.85]). Baseline values influenced progression for VA and percentage change in GVF area, whereas total percentage change in EZ width did not differ across baseline values.</div></div><div><h3>Conclusions</h3><div>Many individuals with RCD did not have a significant 15-letter decline in VA over a 10-year follow-up, highlighting the challenges of relying on VA as a measure of disease progression. Symmetry between eyes varies, emphasizing a key consideration for selection of outcome measures in IRD clinical trials.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100649"},"PeriodicalIF":3.2,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Autologous Neurosensory Retinal Flap Transplantation in a Porcine Model of Retinal Hole","authors":"Madeline E. Olufsen MD ,&nbsp;Jens Hannibal MD ,&nbsp;Nina B. Soerensen MD ,&nbsp;Anders T. Christiansen MD ,&nbsp;Ulrik C. Christensen MD ,&nbsp;Grazia Pertile MD ,&nbsp;David H. Steel MD ,&nbsp;Steffen Heegaard MD ,&nbsp;Jens F. Kiilgaard MD","doi":"10.1016/j.xops.2024.100644","DOIUrl":"10.1016/j.xops.2024.100644","url":null,"abstract":"<div><h3>Purpose</h3><div>Autologous retinal transplantation has been successfully employed in the treatment of large and myopic macular holes that are refractory to standard surgical treatments. Patients transplanted with a peripheral neurosensory retinal graft have shown unexpected improvements in visual acuity. The study aims to investigate if neural integration of the graft takes place in a porcine model of retinal hole.</div></div><div><h3>Design</h3><div>Experimental animal study.</div></div><div><h3>Subjects</h3><div>Left eyes of 10 Danish landrace pigs.</div></div><div><h3>Methods</h3><div>The pigs underwent vitrectomy under general anesthesia, and a subretinal bleb was created within the visual streak on both sites of the optic disc. A retinal hole, approximately 1900 to 4000 microns in size, was cut temporally using a vitrector. A graft of matching size was harvested from the nasal retina. The graft was gently moved toward the retinal hole under perfluoro-n-octane and placed within it. Endolaser was applied around the donor site, and either air or oil tamponade was used. OCT and color fundus photography were performed 2 and 6 weeks after surgery. At the end of follow-up, the eyes were enucleated for histological examination, including immunohistochemical analysis with antibodies against retinal glial cells, photoreceptors, and inner retinal neurons.</div></div><div><h3>Main Outcome Measures</h3><div>The primary outcome measures were the morphology of the graft and the junctional area between the host and the graft.</div></div><div><h3>Results</h3><div>Retinal hole closure was achieved in 9 of 10 cases, with the graft remaining in situ in 6 cases. In 4 cases, OCT scans indicated preservation of the outer retinal layers, and in 2 of these cases, there was apparent integration with the adjacent host retina. Corresponding histology confirmed the preservation of the photoreceptor layer in 3 cases, but there was no evidence of graft integration with degeneration of the inner retina in all cases. The distance between the margins of the retinal hole decreased during follow-up, suggesting that the graft contracts and drags the surrounding retina toward the center.</div></div><div><h3>Conclusions</h3><div>The outer retina of a retinal graft can be preserved, while the inner retina degenerates. No evidence of neuroretinal integration of the graft was observed. The retinal graft serves as a scaffold, promoting the centripetal migration of the edges of the hole, resulting in closure of large retinal holes.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100644"},"PeriodicalIF":3.2,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699102/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142934009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cover","authors":"","doi":"10.1016/S2666-9145(24)00176-3","DOIUrl":"10.1016/S2666-9145(24)00176-3","url":null,"abstract":"","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"4 6","pages":"Article 100640"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retinoblastoma with and without Extraocular Tumor Extension","authors":"Swathi Kaliki MD ,&nbsp;Vijitha S. Vempuluru MD ,&nbsp;Ido Didi Fabian MD","doi":"10.1016/j.xops.2024.100637","DOIUrl":"10.1016/j.xops.2024.100637","url":null,"abstract":"<div><h3>Purpose</h3><div>To study the treatment and outcomes of children with retinoblastoma (RB) with extraocular tumor extension (RB-EOE) and compare them with RB without extraocular tumor extension (RB-w/o-EOE).</div></div><div><h3>Design</h3><div>Multicenter intercontinental collaborative prospective study from 2017 to 2020. RB-EOE cases included those with overt orbital tumor extension in treatment-naive patients. Cases with microscopic orbital extension detected postenucleation were excluded from the study.</div></div><div><h3>Participants</h3><div>A total of 319 children with RB-EOE and 3116 children with RB-w/o-EOE.</div></div><div><h3>Intervention</h3><div>Chemotherapy, enucleation, exenteration, radiotherapy.</div></div><div><h3>Main Outcome Measures</h3><div>Systemic metastasis and death.</div></div><div><h3>Results</h3><div>Of the 3435 RB patients included in this study, 309 (9%) were from low-income countries (LIC), 1448 (42%) from lower-middle income, 1012 (29%) from upper-middle income, and 666 (19%) patients from high-income countries. There was an inverse relationship between the percentage of RB-EOE and national income level, with 96 (31%) patients from LIC, 197 (6%) lower-middle income, 20 (2%) upper-middle income, and 6 (1%) patients from high-income countries (<em>P</em> = 0.0001). The outcomes were statistically significant for RB-EOE compared with RB-w/o-EOE: systemic metastasis (32% vs. 4% respectively; <em>P</em> = 0.0001) and metastasis-related death (63% vs. 6% respectively; <em>P</em> = 0.0001). Multimodal treatment was the most common form of treatment (n = 177; 54%) for RB-EOE, with most cases undergoing a combination of intravenous chemotherapy and enucleation (n = 97; 30%). Adjuvant external beam radiotherapy (EBRT) after surgery (enucleation/orbital exenteration) was given in only 68 (21%) cases. Kaplan–Meier analysis for systemic metastasis and metastasis-related death in RB-EOE was 28% and 57% at 1 year, 29% and 60% at 2 years, and 29% and 61% at 3 years, respectively. Cox regression analysis revealed that the risk of death from RB-EOE was greater in patients aged &gt;4 years than &lt;2 years (hazard ratio, 2.912; <em>P</em> &lt; 0.001) and for unimodal (surgery or intravenous chemotherapy) and bimodal (surgery and intravenous chemotherapy) treatment than trimodal treatment (surgery, intravenous chemotherapy, and EBRT) (hazard ratio, 2.023; <em>P</em> = 0.004 and hazard ratio, 1.819; <em>P</em> = 0.027, respectively).</div></div><div><h3>Conclusions</h3><div>Retinoblastoma with extraocular tumor extension is associated with a higher risk of metastasis and death. Patients with RB-EOE are likely to benefit from trimodal treatment (intravenous chemotherapy, surgery, and EBRT) rather than treatment protocols excluding EBRT.</div></div><div><h3>Financial Disclosure(s)</h3><div>The authors have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100637"},"PeriodicalIF":3.2,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11696820/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual Reality Portable Perimetry and Home Monitoring of Glaucoma: Retention and Compliance over a 2-year Period","authors":"Runjie B. Shi MD, PhD ,&nbsp;Leo Y. Li-Han PhD ,&nbsp;Irfan N. Kherani MD, FRCSC ,&nbsp;Graham E. Trope PhD, FRCSC ,&nbsp;Yvonne M. Buys MD, FRCSC ,&nbsp;Willy Wong PhD ,&nbsp;Moshe Eizenman PhD","doi":"10.1016/j.xops.2024.100639","DOIUrl":"10.1016/j.xops.2024.100639","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate long-term retention, compliance, and performance of glaucoma patients using a virtual reality portable perimeter to monitor visual fields (VFs) at home.</div></div><div><h3>Design</h3><div>Prospective, longitudinal, cohort study.</div></div><div><h3>Subjects</h3><div>Twenty-five glaucoma patients with stable and reliable VFs (average age 67.4 years) were recruited at Toronto Western Hospital, Ontario, Canada.</div></div><div><h3>Methods</h3><div>Participants were instructed to perform bilateral home VF tests fortnightly for 2 years using the Toronto Portable Perimeter (TPP). Based on empirical home monitoring data, simulation analyses were conducted to evaluate the progression detection performance of high-frequency TPP testing.</div></div><div><h3>Main Outcome Measures</h3><div>Retention rates were calculated as the percentage of participants who performed ≥1 home VF test. Compliance rates measured the percentage of participants adhering to the recommended test frequency of every 2-month period. Visual field indices, test reliability, intertest variability, and the precision of estimating progression rate with TPP were compared to those with the Humphrey Field Analyzer (HFA). After 6 months, participants completed a questionnaire to evaluate their experiences and preferences. The years required to detect progression were also compared between HFA and TPP tests.</div></div><div><h3>Results</h3><div>Eighteen of the 25 participants (72%) completed ≥1 unsupervised VF test at home, with an average test frequency of 1.6 tests/month. Compliance decreased as the monitoring duration progressed, dropping from 83% (initial 2 months) to 11% (final 2 months). Unfamiliarity with technology and time constraints were identified as the main barriers to regular testing. Visual field indices of TPP home tests were strongly correlated with clinical results (<em>r</em> &gt; 0.900). Home testing significantly reduced intertest variability (<em>P</em> &lt; 0.001) and improved the precision of progression rate estimates (<em>P</em> &lt; 0.010). Participants overwhelmingly preferred home testing over clinic VF follow-ups (<em>P</em> &lt; 0.001). Simulations showed that TPP tests can significantly shorten the time to detect progression for different progression rates compared with clinical VF follow-up, even with compromised compliance.</div></div><div><h3>Conclusions</h3><div>Despite the small sample size, our study demonstrated that glaucoma patients could reliably perform VF tests at home over a 2-year period. However, issues with retention rate and compliance with long-term VF monitoring were observed in some participants. Nevertheless, high-quality VF data from home tests can provide supplementary information to improve the timely detection of VF progression.</div></div><div><h3>Financial Disclosure(s)</h3><div>The author(s) have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100639"},"PeriodicalIF":3.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142743643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retinal Vascular Permeability in Diabetic Subjects without Retinopathy Compared with Mild Diabetic Retinopathy and Healthy Controls","authors":"Sarah R. Vavrek ,&nbsp;Elif Kayaalp Nalbant PhD ,&nbsp;Nicholas Konopek ,&nbsp;Nicole L. Decker ,&nbsp;Amani A. Fawzi MD ,&nbsp;William F. Mieler MD ,&nbsp;Kenneth M. Tichauer PhD ,&nbsp;Jennifer J. Kang-Mieler PhD","doi":"10.1016/j.xops.2024.100636","DOIUrl":"10.1016/j.xops.2024.100636","url":null,"abstract":"<div><h3>Objective</h3><div>To investigate retinal vascular permeability mapping as a potential biomarker for diabetic retinopathy in subjects with diabetes with no signs of retinopathy and with mild nonproliferative retinopathy.</div></div><div><h3>Design</h3><div>This is a case-control study.</div></div><div><h3>Subjects</h3><div>Participants included 7 healthy controls, 22 subjects with diabetes mellitus and no clinical signs of retinopathy (DMnoDR), and 7 subjects with mild nonproliferative diabetic retinopathy (NPDR).</div></div><div><h3>Methods</h3><div>All participants underwent routine retinal fluorescein videoangiography (FVA). Each FVA dataset was analyzed with the dynamic tracer kinetic model (DTKM) method to estimate 5 parameters: extraction fraction (<em>E</em>), blood flow, arrival time, transit time, and rate constant defined via adiabatic solution. The DTKM method was based on indicator dilution theory, including sequential use of 2 prominent kinetic models: the plug flow model and the adiabatic approximation to the tissue homogeneity model.</div></div><div><h3>Main Outcome Measures</h3><div>Extraction fraction, i.e., the fluorescein dye leakage measured during 1 pass through surrounding retinal tissue, is extracted via DTKM method and directly relates to retinal vascular permeability. Thus, <em>E</em> represents the preclinical biomarker, retinal vascular permeability.</div></div><div><h3>Results</h3><div>The 3 diagnostic groups were found to have significantly different permeability (<em>P</em> = 0.003). Despite having no clinical signs of retinopathy, the mean rank of average vascular <em>E</em> was significantly higher in DMnoDR subjects compared with healthy controls (<em>P</em> = 0.04), as was the mean rank of <em>E</em> for mild NPDR subjects (<em>P</em> = 0.002). The average <em>E</em> for mild NPDR, DMnoDR, and control subjects was 0.10 ± 0.04, 0.07 ± 0.04, and 0.04 ± 0.01, respectively.</div></div><div><h3>Conclusions</h3><div>The vascular permeability extracted from FVA datasets using the DTKM method is a promising biomarker for detecting preclinical retinal pathology in patients with diabetes. Longitudinal studies are ongoing to explore the ability of this biomarker to distinguish those subjects with diabetes who will progress to clinically apparent retinopathy from those who will not.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100636"},"PeriodicalIF":3.2,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664132/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ocular Adverse Events Following Coronavirus Disease 2019 Infection: A Self-controlled Case Series Study from the Entire Korean Population","authors":"Sungsoon Hwang MD, PhD ,&nbsp;Se Woong Kang MD, PhD ,&nbsp;Jaehwan Choi MD ,&nbsp;Kyung-Ah Park MD, PhD ,&nbsp;Dong Hui Lim MD, PhD ,&nbsp;Ju-Young Shin PhD ,&nbsp;Danbee Kang PhD ,&nbsp;Juhee Cho PhD ,&nbsp;Sang Jin Kim MD, PhD","doi":"10.1016/j.xops.2024.100638","DOIUrl":"10.1016/j.xops.2024.100638","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aimed to assess the risk of ocular adverse events, including retinal artery occlusion (RAO), retinal vein occlusion (RVO), noninfectious uveitis (NIU), noninfectious scleritis (NIS), optic neuritis (ON), ischemic optic neuropathy (ION), and ocular motor cranial nerve palsy (OMCNP), after coronavirus disease 2019 (COVID-19) infection.</div></div><div><h3>Design</h3><div>Population-based self-controlled case series (SCCS).</div></div><div><h3>Participants</h3><div>The study included patients from the entire Korean population of 52 million who experienced incident RAO, RVO, anterior NIU, nonanterior NIU, NIS, ON, ION, or OMCNP between January 1, 2021, and October 29, 2022.</div></div><div><h3>Methods</h3><div>This nationwide SCCS utilized data from the Korea National Health Insurance Service and the Korea Disease Control and Prevention Agency. The risk period after infection was defined as up to 24 weeks after COVID-19 infection. Conditional Poisson regression was used to calculate the relative incidence rate ratios (IRRs) for RAO, RVO, anterior NIU, nonanterior NIU, NIS, ON, ION, and OMCNP during the designated risk periods.</div></div><div><h3>Main Outcome Measures</h3><div>The IRRs for RAO, RVO, anterior NIU, nonanterior NIU, NIS, ON, ION, and OMCNP during the risk periods.</div></div><div><h3>Results</h3><div>The study included 9336, 103 362, 201 010, 25 428, 23 744, 3026, 69 933, and 16 335 cases of incident RAO, RVO, anterior NIU, nonanterior NIU, NIS, ON, ION, and OMCNP, respectively. The IRRs (95% confidence interval) during the early risk period (1–8 weeks) were 0.94 (0.83–1.07), 1.01 (0.97–1.04), 1.00 (0.98–1.03), 0.96 (0.90–1.03), 1.00 (0.94–1.07), 0.97 (0.81–1.17), 0.97 (0.93–1.01), and 1.02 (0.94–1.11), respectively. In the late risk period (9–24 weeks), the IRRs were 1.02 (0.92–1.12), 1.01 (0.98–1.04), 1.01 (0.99–1.03), 1.02 (0.97–1.08), 1.02 (0.97–1.08), 0.99 (0.85–1.15), 1.02 (0.99–1.06), and 0.97 (0.90–1.03), respectively. Stratified analyses showed that in patients with a history of cerebro-cardiovascular disease, the risk of RAO increased during the late risk period, with an IRR (95% confidence interval) of 1.19 (1.02–1.40).</div></div><div><h3>Conclusions</h3><div>The risk of incident RVO, anterior NIU, nonanterior NIU, NIS, ON, ION, or OMCNP did not increase after COVID-19 infection. The risk of incident RAO increased only in individuals with preexisting cardio-cerebrovascular disease.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100638"},"PeriodicalIF":3.2,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence","authors":"Anish Salvi MS ,&nbsp;Julia Cluceru PhD ,&nbsp;Simon S. Gao PhD ,&nbsp;Christina Rabe PhD ,&nbsp;Courtney Schiffman PhD ,&nbsp;Qi Yang PhD ,&nbsp;Aaron Y. Lee MD, MSCI ,&nbsp;Pearse A. Keane MD, FRCOphth ,&nbsp;Srinivas R. Sadda MD ,&nbsp;Frank G. Holz MD ,&nbsp;Daniela Ferrara MD, PhD ,&nbsp;Neha Anegondi MTech","doi":"10.1016/j.xops.2024.100635","DOIUrl":"10.1016/j.xops.2024.100635","url":null,"abstract":"<div><h3>Purpose</h3><div>The region of growth (ROG) of geographic atrophy (GA) throughout the macular area has an impact on visual outcomes. Here, we developed multiple deep learning models to predict the 1-year ROG of GA lesions using fundus autofluorescence (FAF) images.</div></div><div><h3>Design</h3><div>In this retrospective analysis, 3 types of models were developed using FAF images collected 6 months after baseline to predict the GA lesion area (segmented lesion mask) at 1.5 years, FAF images collected at baseline and 6 months to predict the GA lesion at 1.5 years, and FAF images collected 6 months after baseline to predict the GA lesion at 1 and 1.5 years. The 1-year ROG from the 6-month visit was derived by taking the difference between the GA lesion area (segmented lesion mask) at the 1.5-year and 6-month visits.</div></div><div><h3>Participants</h3><div>Patients enrolled in the following lampalizumab clinical trials and prospective observational studies: NCT02247479, NCT02247531, NCT02479386, and NCT02399072.</div></div><div><h3>Methods</h3><div>Datasets of study eyes from 597 patients were split into model training (310), validation (78), and test sets (209), stratified by baseline or initial lesion area, lesion growth rate, foveal involvement, and focality. Deep learning experiments were performed using the 2-dimensional U-Net; whole-lesion and multiclass models were developed.</div></div><div><h3>Main Outcome Measures</h3><div>The performance of the models was evaluated by calculating the Dice score, coefficient of determination (R²), and the squared Pearson correlation coefficient (r²) between the true and derived GA lesion 1-year ROG.</div></div><div><h3>Results</h3><div>The model using baseline and 6-month FAF images to predict GA lesion enlargement at 1.5 years had the best performance for the derived 1-year ROG. Mean Dice scores were 0.73, 0.68, and 0.70 in the training, validation, and test sets, respectively. The R² (0.77, 0.53, and 0.79) and r² (0.83, 0.61, and 0.79) showed similar trends across the 3 sets.</div></div><div><h3>Conclusions</h3><div>These findings show the potential of using baseline and/or 6-month visit FAF images to predict 1-year GA ROG using a deep learning approach. This work could potentially help support decision-making in clinical trials and more informed treatment decisions in clinical practice.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100635"},"PeriodicalIF":3.2,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699103/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Substance P- and Insulin-like Growth Factor 1-derived Tetrapeptides for Neurotrophic Keratopathy Related to Leprosy: A Clinical Trial","authors":"Shoko Kondo MD ,&nbsp;Yoshiko Okano MD, PhD ,&nbsp;Satoshi Iraha MD, PhD ,&nbsp;Shoji Tokunaga PhD","doi":"10.1016/j.xops.2024.100634","DOIUrl":"10.1016/j.xops.2024.100634","url":null,"abstract":"<div><h3>Purpose</h3><div>Neurotrophic keratopathy is part of the leprosy sequelae and causes progressive deterioration of visual acuity. Although leprosy is bacteriologically curable, there is currently no efficient treatment. Eye drops containing tetrapeptides, phenylalanine-glycine-leucine-methionine-amide (FGLM-NH₂) and serine-serine-serine-arginine (SSSR), derived from substance P and insulin-like growth factor 1, are clinically efficacious in the treatment of corneal epithelial disorders caused by neurotrophic keratopathy. To further investigate the effect of this treatment on leprosy sequalae, we evaluated the clinical efficacy of FGLM-NH₂+SSSR eye drops for treating neurotrophic keratopathy.</div></div><div><h3>Design</h3><div>Clinical trial: interventional, multicenter, exploratory, single-arm, before and after comparison.</div></div><div><h3>Participants</h3><div>The eyes (12) of 11 patients, aged &gt;60 years, were studied from 2 leprosy sanatoriums in Japan.</div></div><div><h3>Methods</h3><div>Patients with neurotrophic keratopathy in leprosy sanatorium, specifically those with corneal perception of &lt;40 mm, assessed by the Cochet-Bonnet corneal esthesiometer, and persistent corneal epithelial defects (PEDs) or corneal stromal thinning, or both, were included in this study. Those treated for infection in the acute phase were excluded from the study. Eye drops containing FGLM-NH₂ 0.05% and SSSR 5 × 10^-6% were administered 4 times daily for up to 3 months. Fluorescein staining and optical corneal sections were photographed using a slit lamp microscope at protocol-set intervals. Where possible, anterior segment OCT was performed before and after the intervention.</div></div><div><h3>Main Outcome Measures</h3><div>The primary outcome measured was improvement in neurotrophic keratopathy. The patient was judged to have improved when ≥1 of the following criteria were met: (1) healing epithelial defects or (2) increased thickness in the thin area of the cornea. Secondary end points were visual acuity, subjective findings, and time to complete healing for a PED.</div></div><div><h3>Results</h3><div>Neurotrophic keratopathy on epithelial defects or stromal thickness improved in 83.3% of the patients (90% confidence interval 56.2%–97.0%, <em>P</em> &lt; 0.00001). The mean value of corrected visual acuity increased −0.16 by logarithm of the minimum angle of resolution. There were no adverse events reported in association with the treatment.</div></div><div><h3>Conclusions</h3><div>We confirmed that FGLM-NH₂+SSSR eye drops are effective for neurotrophic keratopathy without any adverse reaction in leprosy. These results should be disseminated to any parties who could need this information.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"5 2","pages":"Article 100634"},"PeriodicalIF":3.2,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11665617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}