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. 2018 May:189:127-138.
doi: 10.1016/j.ajo.2018.02.012. Epub 2018 Mar 15.

Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints

Kimberly J Cocce  1 , Sandra S Stinnett  1 , Ulrich F O Luhmann  2 , Lejla Vajzovic  1 , Anupama Horne  1 , Stefanie G Schuman  1 , Cynthia A Toth  1 , Scott W Cousins  1 , Eleonora M Lad  3
Affiliations

Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints

Kimberly J Cocce et al. Am J Ophthalmol. 2018 May.

Abstract

Purpose: To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD.

Design: Cross-sectional analysis of baseline data from a prospective study.

Methods: One hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests.

Results: Functional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m2) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD.

Conclusions: Our study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD.

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Figures

Figure 1
Figure 1. Boxplot of Low Luminance Visual Acuity, standard and computerized
Boxplot showing LLVA testing: (Left) standard and computerized at (Middle) 1.3 cd/m2 (LLVA1) or (Right)) 0.5 cd/m2 (LLVA2) for control and each AMD AREDS clinical group. LLVA measures are reported in ETDRS letters.
Figure 2
Figure 2. Examples of functional testing performed in a patient with intermediate AMD
(Top Left) Report of the cone contrast test (CCT) showing a marked reduction in all cone tones; 90–100% represents a normal score. (Top Right) Dark adaptometry graph with rod intercept of 16 min (normal range < 7 min). (Bottom Left) Macular pigment optical density report screen: green circle represents plateau or reference point set at 7°, red circle at 0.5° and blue circle at 1° from foveal center. (Bottom Right) MAIA microperimetry SLO image showing decreased retinal sensitivities in multiple loci (normal retinal sensitivity > 25 dB), reported average threshold and percent reduced threshold values.
Figure 3
Figure 3. Boxplot of mesopic microperimetry percent reduced threshold
Boxplot showing percent reduced threshold (PRT) on microperimetry testing for control and each AMD AREDS clinical group. PRT measured by percent.
See this image and copyright information in PMC

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