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1.
Ophthalmology ; 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38878904

ABSTRACT

OBJECTIVE: Complications associated with intravitreal anti-vascular endothelial growth factor (VEGF) therapies are inconsistently reported in the literature, thus limiting an accurate evaluation and comparison of safety between studies. This study aimed to develop a standardized classification system for anti-VEGF ocular complications using the Delphi consensus process. DESIGN: Systematic review and Delphi consensus process. PARTICIPANTS: 25 international retinal specialists participated in the Delphi consensus survey. METHODS: A systematic literature search was conducted to identify complications of intravitreal anti-VEGF agent administration based on randomized controlled trials (RCTs) of anti-VEGF therapy. A comprehensive list of complications was derived from these studies, and this list was subjected to iterative Delphi consensus surveys involving international retinal specialists that voted on inclusion, exclusion, rephrasing, and addition of complications. As well, surveys determined specifiers for the selected complications. This iterative process helped refine the final classification system. MAIN OUTCOME MEASURES: The proportion of retinal specialists who choose to include or exclude complications associated with anti-VEGF administration. RESULTS: After screening 18,229 articles, 130 complications were initially categorized from 145 included RCTs. Participant consensus via the Delphi method resulted in the inclusion of 91 (70%) complications after three rounds. After incorporating further modifications made based on participant suggestions, such as rewording certain phrases and combining similar terms, 24 redundant complications were removed, leaving a total of 67 (52%) complications in the final list. A total of 14 (11%) complications met exclusion thresholds and were eliminated by participants across both rounds. All other remaining complications not meeting inclusion or exclusion thresholds were also excluded from the final classification system after the Delphi process terminated. In addition, 47 out of 75 (63%) proposed complication specifiers were included based on participant agreement. CONCLUSION: Using the Delphi consensus process, a comprehensive, standardized classification system consisting of 67 ocular complications and 47 unique specifiers was established for intravitreal anti-VEGF agents in clinical trials. The adoption of this system in future trials could improve consistency and quality of adverse event reporting, potentially facilitating more accurate risk-benefit analyses.

2.
Clin Exp Ophthalmol ; 52(3): 355-364, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38334000

ABSTRACT

Advances in the care of premature infants have resulted in unprecedented rates of survival of these infants into adulthood, including those born at very low gestational ages. Ophthalmologists have historically followed premature infants to assess for the presence of and potential need for treatment of retinopathy of prematurity. However, a growing body of literature suggests that the ophthalmic consequences of prematurity extended beyond retinopathy of prematurity and that ophthalmic sequelae of prematurity can endure through adulthood even among formerly preterm adults who were never diagnosed with retinopathy of prematurity. These abnormalities can include a range of both anterior segment and posterior segment sequelae, including higher rates of corneal aberrations, ocular hypertension, strabismus, foveal anomalies, and retinal tears and detachments. This review aims to summarise this literature, underscoring the importance of lifelong examinations and regular monitoring for these complications among adults who were born prematurely.


Subject(s)
Retinopathy of Prematurity , Strabismus , Infant, Newborn , Infant , Adult , Humans , Child , Retinopathy of Prematurity/diagnosis , Retinopathy of Prematurity/epidemiology , Retinopathy of Prematurity/complications , Infant, Premature , Gestational Age , Strabismus/etiology , Disease Progression , Fovea Centralis
3.
Curr Opin Ophthalmol ; 34(3): 195-202, 2023 May 01.
Article in English | MEDLINE | ID: mdl-36943458

ABSTRACT

PURPOSE OF REVIEW: Age-related macular degeneration (AMD) is one of the leading causes of blindness and can progress to geographic atrophy (GA) in late stages of disease. This review article highlights recent literature which assists in the accurate and timely identification of GA, and monitoring of GA progression. RECENT FINDINGS: Technology for diagnosing and monitoring GA has made significant advances in recent years, particularly regarding the use of optical coherence tomography (OCT). Identification of imaging features which may herald the development of GA or its progression is critical. Deep learning applications for OCT in AMD have shown promising growth over the past several years, but more prospective studies are needed to demonstrate generalizability and clinical utility. SUMMARY: Identification of GA and of risk factors for GA development or progression is essential when counseling AMD patients and discussing prognosis. With new therapies on the horizon for the treatment of GA, identification of risk factors for the development and progression of GA will become critical in determining the patients who would be appropriate candidates for new targeted therapies.


Subject(s)
Geographic Atrophy , Macular Degeneration , Humans , Geographic Atrophy/diagnosis , Geographic Atrophy/etiology , Disease Progression , Fluorescein Angiography , Macular Degeneration/diagnosis , Prognosis , Tomography, Optical Coherence/methods , Atrophy/complications
4.
Retina ; 40(2): 303-311, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31972801

ABSTRACT

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


Subject(s)
Conjunctiva/surgery , Conjunctival Diseases/etiology , Postoperative Complications/etiology , Prosthesis Implantation/adverse effects , Retinitis Pigmentosa/surgery , Visual Prosthesis/adverse effects , Conjunctival Diseases/epidemiology , Conjunctival Diseases/prevention & control , Europe/epidemiology , Female , Humans , Incidence , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Prosthesis Implantation/methods , Retrospective Studies , United States/epidemiology
5.
Exp Eye Res ; 184: 30-37, 2019 07.
Article in English | MEDLINE | ID: mdl-30978346

ABSTRACT

A patient with bilateral diffuse uveal melanocytic proliferation (BDUMP) associated with endometrial cancer was treated with plasmapheresis, but failed therapy with progressive serous retinal detachment. We collected plasma before and after plasmapheresis therapy. Our goal was to determine if the cultured melanocyte elongation and proliferation (CMEP) factor and hepatocyte growth factor (HGF) was present in the IgG enriched fraction and understand why our patient failed plasmapheresis therapy. Melanocytes were cultured for 3-5 days in the presence of control medium, unfractionated pre-plasmapheresis BDUMP medium, IgG enriched or IgG depleted BDUMP medium, or unfractionated post-plasmapheresis BDUMP medium. Subretinal fluid was collected from patients with BDUMP and control retinal detachments and analyzed by electropheresis with immunoblotting. Medium with unfractionated BDUMP plasma stimulated melanocyte growth 1.4-1.5 fold compared to control medium on days 3-5 (p < 0.001 for all). Both IgG enriched and IgG depleted BDUMP medium mildly increased melanocyte growth 1.3 fold (p < 0.05 for enriched, p < 0.01 for depleted) compared to control. In comparison, unfractionated BDUMP medium caused a 1.7-fold increase in melanocyte growth, which was significantly more than the enriched (p < 0.01) and depleted (p < 0.05) fractions. Pre-plasmapheresis and post-plasmapheresis unfractionated BDUMP medium equally stimulated melanocyte growth 1.7-fold (p < 0.05) compared to control. HGF was present in IgG depleted, pre-plasmapheresis, and post-plasmapheresis samples, but absent in the IgG enriched fraction. There was no enrichment of IgG in the subretinal fluid from eyes with BDUMP. In conclusion, CMEP factor is not concentrated in the IgG enriched plasma fraction in our patient who failed plasmapheresis therapy. HGF levels have no correlation with melanocyte growth. Because plasmapheresis preferentially removes immunoglobulins from the plasma, our patient responded poorly to plasmapheresis treatment with worsening retinal detachment.


Subject(s)
Adenocarcinoma, Clear Cell/pathology , Endometrial Neoplasms/pathology , Intercellular Signaling Peptides and Proteins/blood , Melanocytes/pathology , Paraneoplastic Syndromes, Ocular/pathology , Uvea/pathology , Adenocarcinoma, Clear Cell/blood , Adenocarcinoma, Clear Cell/therapy , Aged , Cell Proliferation , Cells, Cultured , Electrophoresis, Polyacrylamide Gel , Endometrial Neoplasms/blood , Endometrial Neoplasms/therapy , Female , Fluorescein Angiography , Humans , Immunoblotting , Multimodal Imaging , Paraneoplastic Syndromes, Ocular/blood , Paraneoplastic Syndromes, Ocular/therapy , Plasmapheresis , Subretinal Fluid , Treatment Failure
6.
Ophthalmology ; 125(7): 1014-1027, 2018 07.
Article in English | MEDLINE | ID: mdl-29409662

ABSTRACT

PURPOSE: To report the 3-year assessment of feasibility and usefulness of microscope-integrated intraoperative OCT (iOCT) during ophthalmic surgery. DESIGN: Prospective, consecutive case series. PARTICIPANTS: Adult participants undergoing incisional ophthalmic surgery with iOCT imaging who consented to be enrolled in the Determination of Feasibility of Intraoperative Spectral-Domain Microscope Combined/Integrated OCT Visualization during En Face Retinal and Ophthalmic Surgery (DISCOVER) study. METHODS: The DISCOVER study is a single-site, multisurgeon, institutional review board-approved investigational device prospective study. Participants included patients undergoing anterior or posterior segment surgery who underwent iOCT imaging with 1 of 3 prototype microscope-integrated iOCT systems (i.e., Zeiss Rescan 700, Leica EnFocus, or Cole Eye iOCT systems). Clinical characteristics were documented, iOCT was directed by the operating surgeon at predetermined surgical time points, and each surgeon completed a questionnaire after surgery to evaluate the usefulness of iOCT during surgery. MAIN OUTCOME MEASURES: Feasibility of iOCT based ability to obtain an OCT image during surgery and usefulness of iOCT based on surgeon reporting during surgery. RESULTS: Eight hundred thirty-seven eyes (244 anterior segment cases and 593 posterior segment cases) were enrolled in the DISCOVER study. Intraoperative OCT demonstrated feasibility with successful image acquisition in 820 eyes (98.0%; 95% confidence interval [CI], 96.8%-98.8%). In 106 anterior segment cases (43.4%; 95% CI, 37.1%-49.9%), the surgeons indicated that the iOCT information impacted their surgical decision making and altered the procedure. In posterior segment procedures, surgeons reported that iOCT enabled altered surgical decision making during the procedure in 173 cases (29.2%; 95% CI, 25.5%-33.0%). CONCLUSIONS: The DISCOVER iOCT study demonstrated both generalized feasibility and usefulness based on the surgeon-reported impact on surgical decision making. This large-scale study confirmed similar findings from other studies on the potential value and impact of iOCT on ophthalmic surgery.


Subject(s)
Eye Diseases/diagnostic imaging , Eye Diseases/surgery , Microscopy/instrumentation , Monitoring, Intraoperative/methods , Ophthalmologic Surgical Procedures , Surgery, Computer-Assisted , Tomography, Optical Coherence/methods , Adolescent , Adult , Ergonomics , Feasibility Studies , Female , Follow-Up Studies , Humans , Male , Prospective Studies , Technology Assessment, Biomedical , Treatment Outcome , Young Adult
7.
Ophthalmology ; 124(7): 1004-1013, 2017 07.
Article in English | MEDLINE | ID: mdl-28366503

ABSTRACT

PURPOSE: To describe a novel macular phenotype that is associated with normal visual function. DESIGN: Retrospective, observational case series. PARTICIPANTS: Thirty-six affected individuals from 23 unrelated families. METHODS: This was a retrospective study of patients who had a characteristic macular phenotype. Subjects underwent a full ocular examination, electrophysiologic studies, spectral-domain optical coherence tomography (OCT), and fundus autofluorescence imaging. Genomic analyses were performed using haplotype sharing analysis and whole-exome sequencing. MAIN OUTCOME MEASURES: Visual acuity, retinal features, electroretinography, and whole-exome sequencing. RESULTS: Twenty-six of 36 subjects were female. The median age of subjects at presentation was 15 years (range, 5-59 years). The majority of subjects were asymptomatic and presented after a routine eye examination (22/36 subjects) or after screening because of a positive family history (13/36 subjects) or by another ophthalmologist (1/36 subjects). Of the 3 symptomatic subjects, 2 had reduced visual acuity secondary to nonorganic visual loss and bilateral ametropic amblyopia with strabismus. Visual acuity was 0.18 logarithm of the minimum angle of resolution (logMAR) or better in 30 of 33 subjects. Color vision was normal in all subjects tested, except for the subject with nonorganic visual loss. All subjects had bilateral symmetric multiple yellow dots at the macula. In the majority of subjects, these were evenly distributed throughout the fovea, but in 9 subjects they were concentrated in the nasal parafoveal area. The dots were hyperautofluorescent on fundus autofluorescence imaging. The OCT imaging was generally normal, but in 6 subjects subtle irregularities at the inner segment ellipsoid band were seen. Electrophysiologic studies identified normal macular function in 17 of 19 subjects and normal full-field retinal function in all subjects. Whole-exome analysis across 3 unrelated families found no pathogenic variants in known macular dystrophy genes. Haplotype sharing analysis in 1 family excluded linkage with the North Carolina macular dystrophy (MCDR1) locus. CONCLUSIONS: A new retinal phenotype is described, which is characterized by bilateral multiple early-onset yellow dots at the macula. Visual function is normal, and the condition is nonprogressive. In familial cases, the phenotype seems to be inherited in an autosomal dominant manner, but a causative gene is yet to be ascertained.


Subject(s)
Eye Proteins/genetics , Macula Lutea/pathology , Macular Degeneration/diagnosis , Mutation , Visual Acuity , Adolescent , Adult , Child , Child, Preschool , DNA Mutational Analysis , Electroretinography , Exome , Eye Proteins/metabolism , Female , Fluorescein Angiography , Follow-Up Studies , Fundus Oculi , Humans , Macular Degeneration/metabolism , Macular Degeneration/physiopathology , Male , Middle Aged , Pedigree , Phenotype , Retrospective Studies , Tomography, Optical Coherence , Young Adult
8.
Retina ; 42(11): 2236-2242, 2022 11 01.
Article in English | MEDLINE | ID: mdl-35067615
10.
Retina ; 35(8): 1688-95, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25768250

ABSTRACT

PURPOSE: To report clinical course and visual and anatomical outcomes of six eyes with histopathologically confirmed vitreous cavity and retina epithelial downgrowth. METHODS: This is a retrospective 15-year review of archived pathologic slides and corresponding medical records of patients with vitreous cavity and retina epithelial downgrowth. Posterior segment epithelial downgrowth was defined as epithelial or goblet cells in the vitreous cavity or on the surface of the retina. RESULTS: Histopathologic diagnosis of epithelial downgrowth was made in 122 patients. Of those, 6 patients (5%) had vitreous cavity and retina epithelial downgrowth. Three patients developed blind painful eye, and epithelial downgrowth was identified in enucleated specimens. The other three eyes with visual potential presented with tractional retinal detachments. Epithelial downgrowth was identified in epiretinal membranes obtained during pars plana vitrectomy. The latter group had more previous surgeries (P = 0.03), and all had keratoprosthesis implantation as their last surgery. All three had pathologic specimens obtained at the time of the keratoprosthesis implantation; no anterior segment epithelial downgrowth was noted in two patients, and one patient had involvement of corneal button, iris, and posterior capsule. Final visual acuity ranged from hand motion to light perception. CONCLUSION: In the current study, vitreous cavity and retina epithelial downgrowth occurred after multiple intraocular surgeries, including repair of the open globe injuries both in enucleated specimens and in eyes with visual potential. In eyes with visual potential, keratoprosthesis implantation seems to predispose the development of posterior segment epithelial downgrowth.


Subject(s)
Epithelial Cells/pathology , Epithelium, Corneal/pathology , Eye Diseases/diagnosis , Retinal Diseases/diagnosis , Visual Acuity/physiology , Vitreous Body/pathology , Adolescent , Adult , Aged , Conjunctiva/pathology , Eye Diseases/surgery , Eye Enucleation , Eye Injuries/surgery , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors
13.
Ophthalmic Surg Lasers Imaging Retina ; 55(4): 204-210, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38319056

ABSTRACT

BACKGROUND AND OBJECTIVE: Geographic atrophy (GA) is a form of late-stage age-related macular degeneration (AMD). This study aims to characterize the journey of patients with GA in real-world ophthalmology practice. PATIENTS AND METHODS: This is a retrospective cohort study of 100 patients with GA and 100 with intermediate AMD (iAMD). RESULTS: Approximately one-third of GA patients' eyes had GA at the time of their initial AMD diagnosis, and nearly half of the iAMD patients' eyes had iAMD at that time. When holding confounders constant, GA patients experienced significantly worse visual acuity outcomes, and a significantly higher proportion required referrals for low vision evaluation, needed assistance for activities of daily living, failed to meet driving standards, and met criteria for legal blindness when compared to iAMD controls. CONCLUSIONS: Many patients have already progressed to GA by the time they receive an AMD diagnosis, emphasizing the importance of providing early detection and intervention, especially considering novel treatment options. [Ophthalmic Surg Lasers Imaging Retina 2024;55:204-210.].


Subject(s)
Geographic Atrophy , Visual Acuity , Humans , Geographic Atrophy/diagnosis , Geographic Atrophy/physiopathology , Retrospective Studies , Female , Male , Aged , Aged, 80 and over , Ophthalmology , Disease Progression , Middle Aged , Tomography, Optical Coherence/methods , Follow-Up Studies , Fluorescein Angiography/methods
14.
J Vitreoretin Dis ; 8(3): 317-324, 2024.
Article in English | MEDLINE | ID: mdl-38770075

ABSTRACT

Purpose: To characterize the visual outcomes and rate of macular hole (MH) closure with tractional retinal detachment (TRD) and proliferative diabetic retinopathy (PDR). Methods: Visit data of patients who had pars plana vitrectomy were retrospectively reviewed; patient demographics, other procedure(s), the MH closure rate, and visual outcomes were also collected. Paired t, Fisher exact, and Mann-Whitney U tests were performed. Results: Ten patients (10 eyes) developed a TRD MH; 3 distinct MH presentations were identified. At the 3-month follow-up, 90% of MHs remained closed without the need for further reoperation (n = 6, type 1 closure; n = 3, type 2 closure). All MHs were closed 12 months after the initial surgery, with 1 eye requiring a single reoperation. The mean visual acuity (VA) at baseline and at 12 months was 20/235 and 20/138, respectively. Conclusions: MHs in the setting of fibrovascular proliferation resulting from PDR present with varied morphology. There is a high rate of MH closure and a trend toward improved VA.

15.
Ophthalmol Retina ; 8(1): 10-17, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37673396

ABSTRACT

PURPOSE: A subset of patients with neovascular age-related macular degeneration (nAMD) experience treatment burden and suboptimal response with anti-VEGF therapy. The aim of this study was to investigate the effect of switching to a novel, bispecific agent, faricimab, in patients with nAMD currently treated with anti-VEGF. DESIGN: Retrospective, noncomparative cohort study. SUBJECTS: Patients with nAMD previously treated with anti-VEGF and switched to intravitreal faricimab injection (IFI) at the Cleveland Clinic's Cole Eye Institute. METHODS: Switching and administration schedule of IFI was at the discretion of the clinician. Visual acuity (VA) and macular OCT parameters, including central subfield thickness (CST), maximum pigment epithelial detachment (PED) height, and presence of subretinal (SRF) or intraretinal fluid (IRF), were assessed at baseline (day of first IFI) and after each IFI. MAIN OUTCOME MEASURES: Central subfield thickness and presence of IRF or SRF after ≥ 3 IFIs. RESULTS: One hundred twenty-six eyes of 106 patients were included in the analysis with a mean follow-up time of 24.3 ± 5.2 weeks. Before switching to IFI, patients received a mean of either aflibercept (20.0 ± 8.4, mean ± standard deviation), bevacizumab (7 ± 8.9), ranibizumab (1.9 ± 8.5), or brolucizumab (0.3 ± 1.6) injections. The most common agent used before switching to IFI was aflibercept (n = 110, 87%), and the mean treatment interval with any anti-VEGF was 5.6 ± 1.6 weeks before switching. Central subfield thickness was reduced from baseline after the first IFI (266.8 ± 64.7 vs. 249.8 ± 58.6 µm, P = 0.02) and persisted over the 3 IFIs (P = 0.01). Pigment epithelial detachment height was reduced after the third IFI (249.6 ± 179.0 vs. 206.9 ± 130.0 µm, P = 0.01). The mean VA (62.9 vs. 62.7 approximate ETDRS letters, P = 0.42) and interval between injections (6.3 vs. 5.7 weeks, P = 0.16) was similar after the third IFI compared with baseline. Eleven (8.7%) eyes were switched back to their previous anti-VEGF, including 2 (1.6%) eyes from 1 patient with intraocular inflammation requiring cessation of IFI. There were no other adverse events from switching. CONCLUSIONS: Switching to faricimab resulted in a reduction in mean CST (-11.6 µm, P = 0.01) and PED height (-44.2 µm, P = 0.01) after 3 injections, with stable VA and at a similar treatment interval to prior anti-VEGF therapy. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.


Subject(s)
Macular Degeneration , Retinal Detachment , Humans , Angiogenesis Inhibitors , Cohort Studies , Retrospective Studies , Treatment Outcome , Retinal Detachment/drug therapy , Macular Degeneration/drug therapy
16.
Ophthalmic Surg Lasers Imaging Retina ; 55(5): 270-277, 2024 May.
Article in English | MEDLINE | ID: mdl-38648428

ABSTRACT

BACKGROUND AND OBJECTIVE: This study compared the surgeon experience between conventional microscope-integrated intraoperative optical coherence tomography (iOCT) and digitally enabled microscope-integrated iOCT in vitreoretinal surgery. PATIENTS AND METHODS: This is a post hoc case-control analysis of the DISCOVER study. Conventional microscope-integrated iOCT (Rescan 700, Zeiss) was compared with digitally enabled iOCT (Artevo 800, Zeiss). Compared variables included surgical field-based visualization (ie, ocular heads-up display in the conventional group; three-dimensional screen-based visualization in the digital iOCT group) and non-surgical field-based visualization (ie, review on the external two-dimensional monitor). RESULTS: A total of 200 patients were included. Surgical field-based visualization of iOCT was significantly higher in the digitally enabled group (P < 0.0001). Required endoillumination level was significantly lower in the digital iOCT group (P < 0.0001). Surgeons reported "significant" back discomfort and headache more frequently when using conventional iOCT (P = 0.003 and P = 0.001, respectively). CONCLUSIONS: Digitally enabled iOCT resulted in greater surgical visualization efficiency, appeared to require a lower illumination level, and may provide advantages for ergonomic-related discomfort. [Ophthalmic Surg Lasers Imaging Retina 2024;55:270-277.].


Subject(s)
Imaging, Three-Dimensional , Microscopy , Tomography, Optical Coherence , Vitreoretinal Surgery , Humans , Tomography, Optical Coherence/methods , Male , Female , Imaging, Three-Dimensional/methods , Microscopy/methods , Middle Aged , Case-Control Studies , Surgery, Computer-Assisted/methods , Aged , Retinal Diseases/surgery , Retinal Diseases/diagnosis
17.
Ophthalmol Retina ; 2024 May 07.
Article in English | MEDLINE | ID: mdl-38719191

ABSTRACT

PURPOSE: To evaluate the impact of reduction in geographic atrophy (GA) lesion growth on visual acuity in the GATHER trials using categorical outcome measures. DESIGN: Randomized, double-masked, sham-controlled phase 3 trials. PARTICIPANTS: Aged ≥50 years with noncenter point-involving GA and best-corrected visual acuity (BCVA) of 25 to 80 ETDRS letters in the study eye. METHODS: GATHER1 consisted of 2 parts. In part 1, 77 patients were randomized 1:1:1 to avacincaptad pegol (ACP) 1 mg, ACP 2 mg, and sham. In part 2, 209 patients were randomized 1:2:2 to ACP 2 mg, ACP 4 mg, and sham. In GATHER2, patients were randomized 1:1 to ACP 2 mg (n = 225) and sham (n = 223). A post hoc analysis of 12-month data for pooled ACP 2 mg and sham groups is reported. MAIN OUTCOME MEASURES: Proportion of study eyes that experienced ≥10-, ≥15-, or ≥20-BCVA ETDRS letter loss from baseline to month 12; time-to-event analysis of persistent vision loss of ≥10, ≥15, or≥ 20 BCVA letters from baseline at ≥2 consecutive visits over 12 months; proportion of study eyes with BCVA loss to a level below driving eligibility threshold at month 12 among those eligible to drive at baseline. RESULTS: Lower proportions of study eyes experienced ≥10-, ≥15-, or ≥20-BCVA letter loss from baseline over 12 months with ACP 2 mg (11.6%, 4.0%, and 1.6%, respectively) versus sham (14.1%, 7.6%, and 4.5%, respectively). There was a reduction in the risk of persistent loss of ≥15 BCVA ETDRS letters with ACP 2 mg (3.4%) versus sham (7.8%) through 12 months. A lower proportion of study eyes treated with ACP 2 mg reached the threshold for driving ineligibility versus sham by 12 months. CONCLUSIONS: Treatment with ACP 2 mg delayed the risk of progression to persistent vision loss (i.e., ≥10-, ≥15-, and ≥20-BCVA letter loss or BCVA loss to a level below driving eligibility threshold) versus sham over 12 months. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

18.
J Vitreoretin Dis ; 7(1): 20-26, 2023.
Article in English | MEDLINE | ID: mdl-37008399

ABSTRACT

Purpose: To assess the short-term and long-term effects of a delay in care on visual acuity (VA) in patients requiring intravitreal injections. Methods: This retrospective cohort study comprised patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO) receiving intravitreal injections. The visual and anatomic outcomes at the next completed visit and at the 1-year follow-up were studied. Results: Of 1172 patients, 38% had a delay in care (mean 5.7 weeks). Compared with baseline, these patients lost VA (Early Treatment Diabetic Retinopathy Study letters) (mean -2.13 ± 0.49 SE) in the short-term (P = .0003) and had a thicker central subfield. Patients with no delay in care had a net VA gain (0.97 ± 0.39) (P = .0067). There was no difference in VA between 1 year and the baseline in either group. Long term, patients with nAMD in both groups had VA loss (no delay in care: -1.76 ± 0.60; delayed care: -2.44 ± 0.78) (P = .0005 and P = .0114, respectively). Patients with DME and no delay in care maintained gains in vision (4.68 ± 1.86) but those with delayed care did not (1.72 ± 2.24) (P = .0202 and P = .3756, respectively). In both groups, patients with RVO had no significant difference in vision from baseline. Conclusions: In patients requiring intravitreal injections, a delay in care of 5.7 weeks affected vision outcomes in the short term but not the long term.

19.
JAMA Ophthalmol ; 141(9): 819-824, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37498609

ABSTRACT

Importance: Language-learning model-based artificial intelligence (AI) chatbots are growing in popularity and have significant implications for both patient education and academia. Drawbacks of using AI chatbots in generating scientific abstracts and reference lists, including inaccurate content coming from hallucinations (ie, AI-generated output that deviates from its training data), have not been fully explored. Objective: To evaluate and compare the quality of ophthalmic scientific abstracts and references generated by earlier and updated versions of a popular AI chatbot. Design, Setting, and Participants: This cross-sectional comparative study used 2 versions of an AI chatbot to generate scientific abstracts and 10 references for clinical research questions across 7 ophthalmology subspecialties. The abstracts were graded by 2 authors using modified DISCERN criteria and performance evaluation scores. Main Outcome and Measures: Scores for the chatbot-generated abstracts were compared using the t test. Abstracts were also evaluated by 2 AI output detectors. A hallucination rate for unverifiable references generated by the earlier and updated versions of the chatbot was calculated and compared. Results: The mean modified AI-DISCERN scores for the chatbot-generated abstracts were 35.9 and 38.1 (maximum of 50) for the earlier and updated versions, respectively (P = .30). Using the 2 AI output detectors, the mean fake scores (with a score of 100% meaning generated by AI) for the earlier and updated chatbot-generated abstracts were 65.4% and 10.8%, respectively (P = .01), for one detector and were 69.5% and 42.7% (P = .17) for the second detector. The mean hallucination rates for nonverifiable references generated by the earlier and updated versions were 33% and 29% (P = .74). Conclusions and Relevance: Both versions of the chatbot generated average-quality abstracts. There was a high hallucination rate of generating fake references, and caution should be used when using these AI resources for health education or academic purposes.


Subject(s)
Artificial Intelligence , Eye , Humans , Cross-Sectional Studies , Hallucinations , Health Education
20.
Ophthalmol Retina ; 7(4): 325-332, 2023 04.
Article in English | MEDLINE | ID: mdl-36280203

ABSTRACT

PURPOSE: To evaluate the anatomic and visual outcomes of patients with idiopathic epiretinal membranes (ERMs) complicated by schisis of the retinal nerve fiber layer (sRNFL) in routine clinical practice. DESIGN: Retrospective case-control study. PARTICIPANTS: Patients undergoing idiopathic ERM surgery at Cole Eye Institute from 2013 to 2021. METHODS: Patients were grouped by the presence or absence of sRNFL before surgery. Preoperative and postoperative data were collected regarding visual acuity (VA), changes in central subfield thickness (CST) over time, and presence of cystoid macular edema. MAIN OUTCOME MEASURES: Frequency of sRNFL in patients undergoing idiopathic ERM surgery. RESULTS: Overall, 48 (53.9%) of 89 patients presented with sRNFL. Schisis of the retinal nerve fiber layer patients presented with significantly decreased VA compared with those without (58.63 ± 12.48 vs. 67.68 ± 7.84 ETDRS letters, P < 0.001, respectively). At the final follow-up after ERM removal, there was no significant difference in final VA in patients with sRNFL compared with those without (71.16 ± 2.93 vs. 74.11 ± 2.76, P = 0.467). At presentation, patients with sRNFL had greater CST than those without (454 ± 10.01 vs. 436 ± 0.23, P = 0.23). This difference persisted at the 90-day follow-up after ERM removal (402 ± 8.08 vs. 375 ± 10.19 µm, P = 0.043). The resolution of sRNFL was reported at postoperative week 1 in 30 (96.7%) of 31 cases. CONCLUSIONS: Schisis of the retinal nerve fiber layer is a microstructural feature in > 50% of idiopathic ERMs in routine clinical practice and carries visual significance on presentation and anatomic significance postoperatively. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Subject(s)
Epiretinal Membrane , Humans , Epiretinal Membrane/surgery , Retrospective Studies , Case-Control Studies , Retina , Nerve Fibers
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