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Glaucoma Progression in American and Korean Cohorts
April 2016
Konstanyan et al. set out to compare the structural and functional progression of glaucoma among U.S. and Korean cohorts. They found differences in type of glaucoma, retinal nerve fiber layer (RNFL) thickness at baseline, and rates of RNFL thinning.
In this retrospective longitudinal study, the investigators examined 313 eyes from 189 glaucoma patients and suspects. Participants were followed for a median of 38 months and examined semiannually using visual field (VF) testing and spectral-domain optical coherence tomography. Each subject had 5 or more documented office visits.
The main outcome measures included rates of change in RNFL thickness, cup-to-disc (C/D) ratios, and VF mean deviation. For each of these parameters, the researchers evaluated the possible effects of a number of variables, including ethnicity, refraction, baseline age, disease severity, disease subtype (high-tension versus normal-tension glaucoma), and clinical diagnosis (glaucoma versus glaucoma suspect).
The Korean cohort, which was composed entirely of Asians participants, predominantly had normal-tension glaucoma. In contrast, the U.S. cohort, which included both white and black participants, was more likely to have high-tension glaucoma. Although both cohorts had similar VF parameters at baseline, the eyes in the Korean cohort had significantly thicker mean RNFL and larger cups than the U.S. cohort. The Korean eyes with glaucoma also demonstrated more rapid RNFL thinning (mean, –0.71 μm per year versus –0.24 μm per year; p < .01). The researchers found no detectable differences in the rate of change between the glaucoma cohorts for C/D ratios and VF mean deviation.
However, when assessing the entire study group (i.e., not comparing the 2 cohorts) for rate of change, the researchers determined that ethnicity, baseline severity, disease subtype, and clinical diagnosis in different combinations had a significant effect on progression. Thus, they concluded that these factors should be considered when comparing glaucoma studies.
Intravitreal Aflibercept in DME Patients With and Without Prior Anti-VEGF Treatment
April 2016
As treatment evolves for diabetic macular edema (DME), researchers are continuing to assess response to laser versus anti-VEGF therapy. Do et al. compared outcomes of intravitreal aflibercept injections (IAI) versus laser treatment in DME patients with or without prior anti-VEGF therapy. They found that IAI produced better outcomes than laser both in patients who had prior anti-VEGF treatment and those who were treatment naive.
The current study is a post hoc analysis of eyes with center-involving DME from 2 randomized controlled double-masked phase 3 trials: VISTA (n = 461) and VIVID (n = 404). In those studies, patients were randomized to 3 groups: 2 mg of IAI every 4 weeks (2q4); 2 mg of IAI every 8 weeks after 5 monthly doses (2q8); or macular laser photocoagulation at baseline with sham injections at study visits.
Of the patients with prior anti-VEGF therapy, a large majority had received only bevacizumab, and treatment ranged from 28 days to 3.9 years. In these patients, the changes in mean best-corrected visual acuity from baseline to 100 weeks in the 3 study groups were as follows: IAI 2q4, +10.9 letters; IAI 2q8, +10.8 letters; and laser, –0.8 letters. For patients without prior anti-VEGF treatment, the changes at week 100 were as follows: IAI 2q4, +12.0 letters; IAI 2q8, +11.3 letters; and laser, +2.1 letters.
Among patients with prior anti-VEGF treatment, mean reductions in central retinal thickness for the 3 study groups were 180.1 μm, 196.4 μm, and 94.1 μm at week 100. Corresponding reductions among patients without prior anti-VEGF treatment were 200.0 μm, 186.7 μm, and 76.9 μm at week 100.
The researchers concluded that IAI yielded better visual anatomic results over laser regardless of prior anti-VEGF treatment status. They also noted that eyes with DME that had been initially treated with anti-VEGF therapy, particularly bevacizumab, had the potential to achieve further improvements after being switched to IAI.
Treatment of Presbyopia Witha Shape-Changing Corneal Inlay
March 2016
Whitman et al. reported the 1-year safety and clinical outcomes of a novel shape-changing corneal inlay designed to treat presbyopia. Their study was a prospective nonrandomized multicenter U.S. FDA Investigational Device Exemption clinical trial.
The 373 emmetropic presbyopic study participants (mean age, 51.3 years), underwent implantation of the Raindrop Near Vision Inlay (ReVision Optics) in their nondominant eye. The corneal inlay was implanted under a corneal flap created with a femtosecond laser centered on the light-constricted pupil. The inlay itself has no refractive power. Rather, it biomechanically raises the stroma and epithelium over the inlay and alters the anterior corneal surface.
Of the initial participants, 340 completed the 1-year follow-up. Main outcome measures were monocular and binocular visual acuity (VA), refractive stability, contrast sensitivity, symptoms, satisfaction questionnaire results, and adverse events.
At 1 year, uncorrected near VA in the participants’ treated eye had improved by 5.1 lines; uncorrected intermediate VA improved by 2.5 lines; and uncorrected distance VA decreased by 1.2 lines. From 3 months through 1 year, 93% of the study participants had uncorrected near VA of 20/25 or better; 97% had an uncorrected intermediate VA of 20/32 or higher; and 95% had uncorrected distance VA of 20/40 or better. Binocularly, the mean uncorrected distance visual acuity exceeded 20/20 from 3 months through 1 year. The researchers noted that contrast sensitivity loss occurred only at the highest spatial frequencies and only in the treated eye.
Visual symptoms (glare, halos, double vision, and fluctuations in vision), were rated as absent or mild in 96% of the participants. Pain, light sensitivity, and discomfort were reported as absent or mild by 99% of subjects. For dry eye symptoms, 95.3% of subjects reported absent or mild dryness, and 4.1% reported moderate dryness; additionally, 1 subject reported marked dryness, and 1 reported severe dryness.
The researchers noted that adverse events were treatable and resolved over time. Eighteen inlays were exchanged, mainly because of decentration; and 11 inlays were explanted, for reasons including patient dissatisfaction with vision, flap problems, or corneal haze. After explantation, the uncorrected distance acuity, on average, returned to within 1 line of preoperative status.
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Ophthalmology summaries are written by Marianne Doran and edited by Susan M. MacDonald, MD.
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