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Visual Acuity, Full-field Stimulus Thresholds, and Electroretinography for 4 Years in The Rate of Progression of USH2A-related Retinal Degeneration (RUSH2A) Study ush2a相关性视网膜变性(RUSH2A)进展速度研究的4年视力、全视野刺激阈值和视网膜电图
IF 3.2
Ophthalmology science Pub Date : 2024-11-08 DOI: 10.1016/j.xops.2024.100648
David G. Birch PhD , Peiyao Cheng PhD , Maureen G. Maguire PhD , Jacque L. Duncan MD , Allison R. Ayala MS , Janet K. Cheetham PharmD , Nicole R. Doucet MPH , Todd A. Durham PhD , Abigail T. Fahim MD, PhD , Frederick L. Ferris III MD , Rachel M. Huckfeldt MD, PhD , Michele Melia ScM , Michel Michaelides MD (Res) , Mark E. Pennesi MD, PhD , José-Alain Sahel MD , Katarina Stingl MD , Ajoy Vincent MBBS, MS , Christina Y. Weng MD, MBA , Foundation Fighting Blindness Clinical Consortium Investigator Group
{"title":"Visual Acuity, Full-field Stimulus Thresholds, and Electroretinography for 4 Years in The Rate of Progression of USH2A-related Retinal Degeneration (RUSH2A) Study","authors":"David G. Birch PhD ,&nbsp;Peiyao Cheng PhD ,&nbsp;Maureen G. Maguire PhD ,&nbsp;Jacque L. Duncan MD ,&nbsp;Allison R. Ayala MS ,&nbsp;Janet K. Cheetham PharmD ,&nbsp;Nicole R. Doucet MPH ,&nbsp;Todd A. Durham PhD ,&nbsp;Abigail T. Fahim MD, PhD ,&nbsp;Frederick L. Ferris III MD ,&nbsp;Rachel M. Huckfeldt MD, PhD ,&nbsp;Michele Melia ScM ,&nbsp;Michel Michaelides MD (Res) ,&nbsp;Mark E. Pennesi MD, PhD ,&nbsp;José-Alain Sahel MD ,&nbsp;Katarina Stingl MD ,&nbsp;Ajoy Vincent MBBS, MS ,&nbsp;Christina Y. Weng MD, MBA ,&nbsp;Foundation Fighting Blindness Clinical Consortium Investigator Group","doi":"10.1016/j.xops.2024.100648","DOIUrl":"10.1016/j.xops.2024.100648","url":null,"abstract":"<div><h3>Purpose</h3><div>To describe progression of best-corrected visual acuity (BCVA), full-field stimulus thresholds (FST), and electroretinography (ERG) over 4 years in the <em>USH2A</em>-related Retinal Degeneration study and to assess their suitability as clinical trial endpoints.</div></div><div><h3>Design</h3><div>Prospective natural history study.</div></div><div><h3>Participants</h3><div>Participants (n = 105) with biallelic disease-causing sequence variants in USH2A and BCVA letter scores of ≥54 were included.</div></div><div><h3>Methods</h3><div>BCVA, FST, fundus-guided microperimetry, static perimetry, and spectral domain OCT were performed annually and ERG at baseline and 4 years only. Mixed effects models were used to estimate annual rates of change with 95% confidence intervals. Associations of change from baseline to 4 years between BCVA, FST, ERG, and other metrics were assessed with Spearman correlation coefficients (r<sub>s</sub>).</div></div><div><h3>Main Outcome Measures</h3><div>Best-corrected visual acuity, FST, and ERG.</div></div><div><h3>Results</h3><div>The annual rate of decline in BCVA was 0.83 (95% confidence interval: 0.65−1.02) letters/year. For FST, the change was 0.09 (0.07−0.11) log cd.s/m<sup>2</sup>/year for white threshold, 0.10 (0.08−0.12) log cd.s/m<sup>2</sup>/year for blue threshold, and 0.05 (0.04−0.06) log cd.s/m<sup>2</sup>/year for red threshold. Changes were 22.6 (17.4−28.2)%/year for white threshold, 26.0 (20.3−32.1)%/year for blue threshold, and 12.3 (8.7−16.0)%/year for red threshold. The high percentage of eyes with undetectable ERGs at baseline limited assessment of change.</div></div><div><h3>Conclusions</h3><div>Best-corrected visual acuity was not a sensitive measure of progression over 4 years. Full-field stimulus threshold was a more sensitive measure; however, additional information on the clinical relevance of changes in FST is needed before this test can be adopted as an endpoint for 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 100648"},"PeriodicalIF":3.2,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985700","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}
引用次数: 0
Long-term Impact of Carotid Endarterectomy on Choroidal and Choriocapillaris Perfusion: The INFLATE Study
IF 3.2
Ophthalmology science Pub Date : 2024-11-08 DOI: 10.1016/j.xops.2024.100651
Alessandro Berni MD , Yi Zhang PhD , Sandy Zhou Wenting MD , Natalie Noam MD , David Rabinovitch BSc , Basheer Sheick Yousif MD , Gissel Herrera MD , Mengxi Shen MD, PhD , Robert O’Brien PhD , Giovanni Gregori PhD , Ruikang K. Wang PhD , Philip J. Rosenfeld MD, PhD , Omer Trivizki MD
{"title":"Long-term Impact of Carotid Endarterectomy on Choroidal and Choriocapillaris Perfusion: The INFLATE Study","authors":"Alessandro Berni MD ,&nbsp;Yi Zhang PhD ,&nbsp;Sandy Zhou Wenting MD ,&nbsp;Natalie Noam MD ,&nbsp;David Rabinovitch BSc ,&nbsp;Basheer Sheick Yousif MD ,&nbsp;Gissel Herrera MD ,&nbsp;Mengxi Shen MD, PhD ,&nbsp;Robert O’Brien PhD ,&nbsp;Giovanni Gregori PhD ,&nbsp;Ruikang K. Wang PhD ,&nbsp;Philip J. Rosenfeld MD, PhD ,&nbsp;Omer Trivizki MD","doi":"10.1016/j.xops.2024.100651","DOIUrl":"10.1016/j.xops.2024.100651","url":null,"abstract":"<div><h3>Purpose</h3><div>When performed for clinically significant carotid artery stenosis (CAS), the long-term impact of carotid endarterectomy (CEA) on choroidal and choriocapillaris (CC) circulation was studied using swept-source OCT angiography.</div></div><div><h3>Design</h3><div>Prospective observational study.</div></div><div><h3>Participants</h3><div>Patients with clinically significant CAS undergoing unilateral CEA.</div></div><div><h3>Methods</h3><div>Swept-source OCT angiography scans were performed on both eyes at baseline (before CEA), within 1 week post-CEA (short-term follow-up [FU]), and ≥30 days post-CEA (long-term FU). Using validated algorithms, we measured mean choroidal thickness (MCT), choroidal vascularity index (CVI), choroidal vessel volume (CVV), CC flow deficit percentage (CC FD%), and CC thickness within the 5-mm circle centered on the fovea for both the eye ipsilateral to CEA (surgical side) and the contralateral eye (nonsurgical side). Multivariable regression analysis was conducted to evaluate the impact of baseline demographic and clinical factors on the changes in choroidal and CC parameters.</div></div><div><h3>Main Outcome Measures</h3><div>Both the short- and long-term changes in MCT, CVI, CVV, CC FD%, and CC thickness.</div></div><div><h3>Results</h3><div>The study included 58 eyes from 29 patients. Significant short-term improvements in MCT (<em>P</em> &lt; 0.001) and CC thickness (<em>P</em> = 0.006) were observed post-CEA on the surgical side. Long-term FU showed sustained increases in MCT compared with baseline (<em>P</em> = 0.02), while CC thickness was not significantly different from baseline (<em>P</em> = 0.10). The CVI did not change significantly from baseline at either short-term (<em>P</em> = 0.45) or long-term (<em>P</em> = 0.22) FU on the surgical side. While CVV demonstrated a short-term rise immediately post-CEA (<em>P</em> &lt; 0.001), the difference was not statistically significant at the long-term evaluation (<em>P</em> = 0.06). No significant improvement in CC FD% from baseline was observed at any visit post-CEA (short-term <em>P</em> = 0.81, long-term <em>P</em> = 0.91). The nonsurgical side only showed a significant reduction in CVI at the long-term FU visit compared with before CEA (<em>P</em> = 0.01). Clinical variables such as age, degree of stenosis, diabetes, hypertension, and smoking status did not greatly impact the outcomes.</div></div><div><h3>Conclusions</h3><div>Unilateral CEA demonstrated a sustained increase in MCT, suggesting persistent improvements in choroidal perfusion in the ipsilateral eye.</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 100651"},"PeriodicalIF":3.2,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030390","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}
引用次数: 0
CANBERRA: A Phase II Randomized Clinical Trial to Test the Therapeutic Potential of Oral Vicasinabin in Diabetic Retinopathy 堪培拉:一项测试口服维卡西那宾治疗糖尿病视网膜病变潜力的II期随机临床试验。
IF 3.2
Ophthalmology science Pub Date : 2024-11-08 DOI: 10.1016/j.xops.2024.100650
Beatriz G. Armendariz PhD , Ulrich F.O. Luhman PhD , Brian Berger MD , Jules Hernandez-Sanchez PhD , Katrijn Bogman PhD , Nikolaos Mitrousis PhD , Martina Wollenhaupt MD , David Kent MD , Andreas Wenzel PhD , Sascha Fauser MD, PhD
{"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}
引用次数: 0
Longitudinal Assessment of Structural and Functional Changes in Rod-cone Dystrophy: A 10-year Follow-up Study 杆状锥体营养不良的结构和功能变化的纵向评估:一项10年随访研究。
IF 3.2
Ophthalmology science Pub Date : 2024-11-06 DOI: 10.1016/j.xops.2024.100649
Alexis Ceecee Britten-Jones BOptom (Hons), PhD , Chi D. Luu BOrth (Hons), PhD , Jasleen K. Jolly MSc, DPhil , Carla J. Abbott BOptom, PhD , Penelope J. Allen MBBS, FRANZCO , Tina Lamey PhD , Terri McLaren BSc , Jennifer A. Thompson PhD , John De Roach PhD , Thomas L. Edwards PhD, FRANZCO , Lauren N. Ayton BOptom, PhD
{"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}
引用次数: 0
Autologous Neurosensory Retinal Flap Transplantation in a Porcine Model of Retinal Hole 自体神经感觉视网膜瓣移植在猪视网膜孔模型中的应用。
IF 3.2
Ophthalmology science Pub Date : 2024-11-05 DOI: 10.1016/j.xops.2024.100644
Madeline E. Olufsen MD , Jens Hannibal MD , Nina B. Soerensen MD , Anders T. Christiansen MD , Ulrik C. Christensen MD , Grazia Pertile MD , David H. Steel MD , Steffen Heegaard MD , Jens F. Kiilgaard MD
{"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}
引用次数: 0
Cover 封面
IF 3.2
Ophthalmology science Pub Date : 2024-11-01 DOI: 10.1016/S2666-9145(24)00176-3
{"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}
引用次数: 0
Retinoblastoma with and without Extraocular Tumor Extension 伴有和不伴有眼外肿瘤扩展的视网膜母细胞瘤:3435例患者的全球比较研究
IF 3.2
Ophthalmology science Pub Date : 2024-10-30 DOI: 10.1016/j.xops.2024.100637
Swathi Kaliki MD , Vijitha S. Vempuluru MD , Ido Didi Fabian MD
{"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}
引用次数: 0
Virtual Reality Portable Perimetry and Home Monitoring of Glaucoma: Retention and Compliance over a 2-year Period 青光眼的虚拟现实便携式视野测量和家庭监测:2年期间的保留和依从性
IF 3.2
Ophthalmology science Pub Date : 2024-10-29 DOI: 10.1016/j.xops.2024.100639
Runjie B. Shi MD, PhD , Leo Y. Li-Han PhD , Irfan N. Kherani MD, FRCSC , Graham E. Trope PhD, FRCSC , Yvonne M. Buys MD, FRCSC , Willy Wong PhD , Moshe Eizenman PhD
{"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}
引用次数: 0
Retinal Vascular Permeability in Diabetic Subjects without Retinopathy Compared with Mild Diabetic Retinopathy and Healthy Controls 无视网膜病变的糖尿病患者与轻度糖尿病视网膜病变及健康对照的视网膜血管通透性比较。
IF 3.2
Ophthalmology science Pub Date : 2024-10-26 DOI: 10.1016/j.xops.2024.100636
Sarah R. Vavrek , Elif Kayaalp Nalbant PhD , Nicholas Konopek , Nicole L. Decker , Amani A. Fawzi MD , William F. Mieler MD , Kenneth M. Tichauer PhD , Jennifer J. Kang-Mieler PhD
{"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}
引用次数: 0
Ocular Adverse Events Following Coronavirus Disease 2019 Infection: A Self-controlled Case Series Study from the Entire Korean Population 2019年冠状病毒病感染后的眼部不良事件:来自韩国全体人口的自控病例系列研究
IF 3.2
Ophthalmology science Pub Date : 2024-10-26 DOI: 10.1016/j.xops.2024.100638
Sungsoon Hwang MD, PhD , Se Woong Kang MD, PhD , Jaehwan Choi MD , Kyung-Ah Park MD, PhD , Dong Hui Lim MD, PhD , Ju-Young Shin PhD , Danbee Kang PhD , Juhee Cho PhD , Sang Jin Kim MD, PhD
{"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}
引用次数: 0
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