Grating acuity and contrast tests for clinical trials of severe vision loss

Purpose.: To evaluate the reliability and validity of grating visual acuity (VA) and contrast sensitivity (CS) tests, which could be useful outcome measures to assess changes in severely reduced vision. Methods.: The Grating Acuity Test (GAT) and Grating Contrast Sensitivity (GCS) tests, which involve the detection of grating orientation in a four-Alternative Forced Choice paradigm on a liquid crystal display screen, were compared with the well-validated Early Treatment of Diabetic Retinopathy Study (ETDRS) and Pelli-Robson (PR) charts. Grating tests were repeated two or three times within-visit, across three or four sessions, in 20 legally blind subjects: 8 with retinitis pigmentosa (RP) (16 eyes) and 12 with other retinal diseases (OR) (16 eyes). Results.: VA determined by ETDRS and GAT was in good agreement and scaled very similarly, as shown by regression of the within-session difference between the two measures against their mean [RP group: slope (m) = 0.11; 95% confidence interval [CI]: -0.06, 0.29; p = 0.21; OR group: m = -0.07; 95% CI: 0.33, 0.20; p = 0.62]. On average, higher logCS levels were obtained using the GCS than the PR in both groups. The two CS measures scaled similarly in the RP group (m = 0.07; 95% CI: -0.09, 0.22; p = 0.39) but not in the OR group (m = 0.41; 95% CI: 0.12, 0.70; p = 0.005). The within- and between-visit 95% coefficient of repeatability (CR.95) were 0.11 to 0.17 log units for the ETDRS charts and GAT in both groups and 0.14 to 0.15 log units for the PR and GCS in the RP group, whereas the OR group demonstrated more variability in CS. Between-visit CR.95 did not significantly change with mean VA or CS for the ETDRS, PR, or GCS tests, but RP patients' CR.95 on the GAT increased significantly with decreasing VA. Floor effects occurred for some RP eyes with ETDRS and PR charts but not with the GAT and GCS. Conclusions.: Computer-driven grating tests appear to be reliable, capable of evaluating vision that may fall outside of the range of standard clinical tests and may be useful during clinical trials for advanced eye disease.