Abstract

Ahmed et al (p. 52) conducted a prospective, multicenter, randomized clinical trial to compare the efficacy of 2 microinvasive glaucoma surgery (MIGS) devices—The Hydrus Microstent and the iStent Trabecular Micro-Bypass Stent System—for reducing intraocular pressure (IOP) and medications in open-angle glaucoma. A total of 152 eyes from 152 patients were randomized 1:1 to standalone MIGS, consisting of either 1 Hydrus Microstent or 2 iStent devices. In the 148 subjects who completed 12-month follow-up, the Hydrus resulted in a higher surgical success rate and fewer medications used compared with the 2-iStent procedure, and both devices had similar safety profiles. The study suggests that MIGS devices could help manage IOP and demonstrates some advantages of the Hydrus Microstent. In 2 similarly designed randomized, double-masked, multicenter phase 3 trials (HAWK and HARRIER), Dugel et al (p. 72) compared brolucizumab, a single-chain antibody fragment that inhibits vascular endothelial growth factor-A, with aflibercept to treat neovascular age-related macular degeneration. A total of 1817 patients were randomized to intravitreal brolucizumab 3 mg (HAWK only) or 6 mg or aflibercept 2 mg. In both trials, each brolucizumab arm demonstrated noninferiority versus aflibercept in best-corrected visual acuity change. More than 50% of brolucizumab 6 mg-treated eyes were maintained on an every-12-weeks dosing through Week 48. At the matched Week 16 assessment, fewer brolucizumab 6 mg-treated eyes had disease activity versus aflibercept in both studies. Anatomic retinal fluid outcomes favored brolucizumab over aflibercept, and overall safety with brolucizumab was similar to aflibercept. The authors conclude that brolucizumab is noninferior to aflibercept in visual function at Week 48 and suggest that it could serve as an alternative treatment option. In a cross-sectional, population-based survey, Ito et al set (p. 107) out to determine the association between retinal thickness and cognitive function. A total of 1293 Japanese persons aged 65 to 86 years underwent comprehensive ophthalmic assessment, as well as detailed mental health examinations to designate them into 3 groups: normal, having mild cognitive impairment, or having dementia. Significant differences were found in the 3 groups in all retinal layers and ganglion cell complex (GCC) thickness, but not in peripapillary retinal nerve fiber layer (ppRNFL) thickness. Ganglion cell complex and macular thicknesses were associated with the presence of dementia, but ppRNFL thickness was not. Ganglion cell-inner plexiform layer, GCC, and full macular thicknesses were all associated with the presence of dementia in the inferior sectors. The results indicate that macular thickness, but not ppRNFL, was associated with the presence of dementia, and the authors suggest that OCT measurements of the macula could be superior in assessing neuro-degenerative changes. Maa et al (p. 38) conducted a prospective comparison between the standard protocol of the Veterans Affairs Healthcare System’s Technology-based Eye Care Services (TECS) and face-to-face (FTF) examination to identify aspects of the process that could be refined to improve accuracy. A total of 256 patients with no known history of significant ocular disease were recruited. The researchers found that TECS readers showed substantial agreement for cataract and diabetic retinopathy, moderate to substantial agreement for glaucoma/glaucoma suspect, and moderate agreement for age-related macular degeneration compared with an FTF examination. The TECS protocol showed high percent agreements and good sensitivity and excellent specificity compared with an FTF eye examination for the detection of common eye diseases. The authors conclude that the standard TECS protocol is comparable with an FTF examination, and its diagnostic capabilities could be enhanced by including additional sophisticated ophthalmic testing. Pflugfelder et al (p. 14) conducted a multicenter, randomized, double-masked vehicle-controlled trial to evaluate the safety and efficacy of topical recombinant human nerve growth factor (cenegermin) in patients with neurotrophic keratopathy. Forty-eight patients were enrolled and randomized 1:1 to receive either cenegermin 20 mg/ml or vehicle eye drops. Cenegermin treatment showed higher rates of corneal healing, with statistically significant differences between treatment groups at week 8. Cenegermin-treated patients showed significantly reduced lesion sizes compared with vehicle-treated patients, and fewer cenegermin-treated patients experienced disease progression over the 8-week treatment course compared with vehicle-treated patients. The researchers found that cenegermin was well tolerated. They conclude that cenegermin treatment could potentially serve as a safe and noninvasive treatment for neurotrophic keratopathy.

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