Review of Ophthalmology Online

FROM THE EDITORS OF REVIEW OF OPHTHALMOLOGY:







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Volume 18, Number 38
Monday, September 17, 2018
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SEPTEMBER IS HEALTHY AGING MONTH



In this issue: (click heading to view article)
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######### Autonomous AI-based Diagnostic System for DR Detection
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######### Macular Morphology and VA in Year Five of CATT
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######### Prevalence of Novel Candidate Sjögren’s Autoantibodies in DREAM Study
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######### Antiplatelet/Anticoagulant Use in Eyes with Optic Disc Hemorrhage
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  Briefly

 

Autonomous AI-based Diagnostic System for DR Detection

This trial evaluated an autonomous artificial intelligence system’s ability to detect diabetic retinopathy in 900 subjects with diabetes but no history of DR at primary care clinics. Researchers compared the AI system’s findings with those of FPRC-certified photographers via widefield stereoscopic photography and macular optical coherence tomography at the Wisconsin Fundus Photograph Reading Center, and FPRC grading of Early Treatment Diabetic Retinopathy Study Severity Scale and diabetic macular edema.

More than mild DR (mtmDR) was defined as ETDRS level 35 or higher and/or DME in at least one eye. AI system operators underwent a standardized training protocol before the study started.

The median age was 59 years (range: 22 to 84 years). Among participants: 47.5 percent were male, 16.1 percent were Hispanic, 83.3 percent weren’t Hispanic, 28.6 percent were African American and 63.4 percent weren’t African American. A total of 198 (23.8 percent) had mtmDR.

The AI system demonstrated exceeded all pre-specified superiority endpoints, with:
• sensitivity of 87.2 percent (CI, 81.8 to 91.2 percent) (>85 percent);
• specificity of 90.7 percent (CI, 88.3 to 92.7 percent) (>82.5 percent); and
• imageability of 96.1 percent (CI, 94.6 to 97.3 percent).

Researchers wrote that these results prompted the FDA to approve the system for clinical use to detect mtmDR and DME, making it the first FDA-approved, autonomous AI diagnostic system in any field of medicine.

SOURCE: Abràmoff MD, Lavin PT, Birch M, et al. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. npj Digital Medicine 2018; Aug. 28. [Epub ahead of print].





Macular Morphology and VA in Year Five of CATT

Investigators evaluated associations of morphologic features with five-year visual acuity in the Comparison of Age-related Macular Degeneration Treatments Trials, as part of a cohort study.

CATT participant eyes with AMD-associated choroidal neovascularization and VA between 20/25 and 20/320 were eligible. Treatment was assigned randomly to ranibizumab or bevacizumab, to three dosing regimens for two years and at the ophthalmologists’ discretion thereafter.

Main outcome measures included: VA, thickness and morphological features on optical coherence tomography, lesion size, and foveal composition on fundus photography and fluorescein angiography.

VA and image gradings were available for 523 of 914 (57 percent) participants alive at five years. At five years:
• Sixty percent of eyes had intraretinal fluid, 38 percent had subretinal fluid, 36 percent had subretinal pigment epithelium fluid and 66 percent had subretinal hyperreflective material.
• Mean (SD) foveal center thickness (μm) was 148 (99) for retina, 5 (21) for SRF, 125 (107) for subretinal tissue complex, 11 (33) for SHRM and 103 (95) for RPE+RPE elevation.
• SHRM, thinner retina, greater CNV lesion area and foveal center pathology (all p<0.001) and IRF (p<0.05) were independently associated with worse VA.
• Adjusted mean VA letters was 62 for no pathology in the foveal center; 61 for CNV, fluid or hemorrhage; 65 for non-geographic atrophy, 64 for non-fibrotic scar, 53 for GA and 56 for fibrotic scars.
• Incidence or worsening of eight pathological features (foveal GA, scar and CNV; SHRM, foveal IRF, retinal thinning, CNV lesion area and GA area) between years two and five were independently associated with greater VA loss between those years, and between baseline and year five.

Investigators found that associations between VA and morphologic features previously identified through year one were maintained or strengthened at year five. They also determined that new foveal scars, CNV, intraretinal fluid, SHRM and retinal thinning; development or worsening of foveal GA; and increased lesion size were important contributors to VA decline from year two to five. Investigators suggested that new therapies were needed to address these adverse pathological features.

SOURCE: Jaffe GJ, Ying G-S, Toth CA, et al. Macular morphology and visual acuity in year five of the Comparison of Age-related Macular Degeneration Treatments Trials (CATT). Ophthalmology 2018; Sept. 3. [Epub ahead of print].



Prevalence of Sjögren’s Autoantibodies in DREAM Study

Scientists evaluated the prevalence of Sjögren’s syndrome autoantibodies [salivary protein-1, parotid secretory protein and carbonic anhydrase 6] in the DRy Eye Assessment and Management cohort, as part of a study evaluating the effectiveness of omega-3 fatty acid supplements for the treatment of dry eye.

Participants underwent ocular surface exams and serological testing for traditional and novel SS autoantibodies. Dry-eye assessment and management participants were categorized into the following three groups: 1) no history of SS or other autoimmune diseases and negative traditional SS autoantibodies (n=352); 2) no history of SS but a history of other autoimmune diseases (n=66); and 3) those who met the 2012 American College of Rheumatology SS classification criteria (n=52).

Eleven percent had a history of SS, and 6 percent of those without a history of SS were suspected of having undiagnosed SS. The SS group had a higher prevalence of SP-1 autoantibodies than the group without SS or other autoimmune diseases (33 percent vs. 19 percent; p=0.02), but had no difference in carbonic anhydrase 6 (p=0.31) or parotid secretory protein autoantibodies (p=0.33). Participants who were positive for traditional autoantibodies alone, or for traditional and novel autoantibodies, had the highest scores for corneal (p=0.002) and conjunctival staining (p<0.001).

Scientists wrote that data demonstrated that novel candidate autoantibody SP-1 was associated with underlying SS, and that that novel autoantibodies might be associated with worse ocular surface disease. They added that future longitudinal studies would be needed to evaluate the utility of the autoantibodies in screening individuals with dry eye for SS.

SOURCE: Bunya VY, Ying GS, Maguire MG, et al. Prevalence of novel candidate Sjögren Syndrome autoantibodies in the Dry Eye Assessment and Management (DREAM) study. Cornea 2018; Aug 29. [Epub ahead of print].




Antiplatelet/Anticoagulant Use in Eyes with Optic Disc Hemorrhage

Researchers assessed whether the use of antiplatelets/anticoagulants affected glaucoma progression in eyes with optic disc hemorrhage. A total of 119 from 119 individuals with primary open-angle glaucoma in whom a DH was observed at least once during the follow-up period (mean follow-up duration: 6.2 y) were included in this retrospective, observational study.

Researchers used Cox proportional hazard models to identify the association between putative factors, including AP/AC use, and glaucoma progression. Researchers assessed glaucoma progression on the basis of changes noted on serial optic disc and retinal nerve fiber layer photographs, or changes in the visual field.

Nineteen individuals took AP/AC drugs daily [AP/AC-use group (AG)], while other participants didn’t [no-use group (NG)]. The follow-up period to progression was significantly different between the two groups (61.2 ±23.5 months for the AG and 47.6 ±22 months for the NG; p=0.016). Kaplan-Meier analysis revealed a greater cumulative probability of glaucoma progression in the NG group than in the AG group, with borderline statistical significance (p=0.081). Higher mean intraocular pressure during the follow-up period was a risk factor for glaucoma progression (HR, 1.107; p=0.014), while AP/AC drug use protected against glaucoma progression (HR, 0.576; p=0.046).

Researchers determined that their results indicated that use of AP/AC drugs was associated with a lower risk of glaucoma progression in eyes with DH.

SOURCE: Lee J, Sung KR, Kwon J, et al. Effect of antiplatelet/anticoagulant use on glaucoma progression in eyes with optic disc hemorrhage. J Glaucoma 2018; Sep 7. [Epub ahead of print].






  • Alcon Adds Ultraviolet-absorbing-Only IOL Options
    Alcon recently expanded its AcrySof intraocular lens portfolio with the introduction of multifocal and multifocal toric ultraviolet-absorbing IOLs, and the introduction of the AcrySof UV-absorbing monofocal IOL with the UltraSert Pre-loaded Delivery System. These lenses come without blue light filtering that some surgeons dislike. The new multifocal and multifocal toric options are the AcrySof ReSTOR +2.5 Multifocal UV-Absorbing IOL with Activefocus optical design and the AcrySof ReSTOR +2.5 Multifocal Toric UV-Absorbing IOL with Activefocus optical design. The unique optical design of the lenses is intended to deliver crisp, clear distance vision and a range of vision for patients who desire less dependence on glasses, the company says. Read more.


  • Apellis Announces First Patient Dosed in Phase III Trials for APL-2 in GA
    Apellis commenced its Phase III clinical program for APL-2 in individuals with geographic atrophy, consisting of two Phase III trials (DERBY and OAKS), with the first subject dosed in OAKS, and the first subject enrolled in DERBY. The trials will assess the safety and efficacy of multiple intravitreal injections of APL-2 in individuals with GA. The Phase III program, consisting of 600 subjects in two prospective, international, multicenter, randomized, double-masked, sham-injection controlled studies, are similar in design to the company’s Phase II FILLY trial, including the eligibility criteria and primary endpoint of change in GA lesion size from baseline to month 12, compared with sham, the company says. In DERBY and OAKS, individuals will continue on therapy for an additional year. Read more.

  • Iridex Introduces Updated TruFocus LIO Premiere Laser Accessory
    Following FDA 510(k) clearance, Iridex introduced its updated TruFocus LIO Premiere laser accessory to the U.S. market. The light combination and reflection viewing system used with Iridex retina laser systems is worn on the physician’s head and combines a laser treatment beam from an Iridex laser source with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam. They physician uses a handheld ophthalmic exam lens to enter a patient’s pupil, and view and treat the retina. Read more.



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