PURPOSE: To assess the rate of change of visual field (VF) mean deviation (MD) in the Ocular Hypertension Treatment Study (OHTS). METHODS: OHTS data were filtered to exclude eyes that had fewer than 10 reliable VFs or less than 5 years of follow-up or that reached a nonglaucomatous endpoint. The rate of change of MD (MDR) was calculated for each eye. Differences were sought between groups of eyes differing in primary open angle glaucoma (POAG) outcome, how POAG was determined, and original randomization. RESULTS:In total, 2609 eyes (1379 participants) met the selection criteria. The mean MDR was -0.08 ± 0.20 dB/y (±SD). POAG eyes (n = 359) had significantly worse MDRs (-0.26 ± 0.36 dB/y) than non-POAG eyes (n = 2250; -0.05 ± 0.14 dB/y; P < 0.001). Eyes that reached POAG endpoints based on only VF change (n = 74; -0.29 ± 0.31 dB/y) or only optic disc change (n = 158; -0.12 ± 0.19 dB/y) had significantly worse MDRs than non-POAG eyes (both P < 0.001). Eyes that reached POAG endpoints for both VF and optic disc change (n = 127) deteriorated more rapidly (-0.42 ± 0.46 dB/y) than eyes showing only VF change (P = 0.017) or only optic disc change (P < 0.001). There was not a significant association between MDR and original OHTS randomization (observe vs. treat, P = 0.168). CONCLUSIONS: Eyes that develop POAG have significantly worse MDRs than eyes that do not. Eyes that reached endpoints due to both VF and optic disc change had worse MDRs than eyes displaying change in only one of these. MDR was not significantly associated with randomization, suggesting that MDR may not be the best measure of VF change in early-stage POAG. (ClinicalTrials.gov number, NCT00000125.).
RCT Entities:
PURPOSE: To assess the rate of change of visual field (VF) mean deviation (MD) in the Ocular Hypertension Treatment Study (OHTS). METHODS: OHTS data were filtered to exclude eyes that had fewer than 10 reliable VFs or less than 5 years of follow-up or that reached a nonglaucomatous endpoint. The rate of change of MD (MDR) was calculated for each eye. Differences were sought between groups of eyes differing in primary open angle glaucoma (POAG) outcome, how POAG was determined, and original randomization. RESULTS: In total, 2609 eyes (1379 participants) met the selection criteria. The mean MDR was -0.08 ± 0.20 dB/y (±SD). POAG eyes (n = 359) had significantly worse MDRs (-0.26 ± 0.36 dB/y) than non-POAG eyes (n = 2250; -0.05 ± 0.14 dB/y; P < 0.001). Eyes that reached POAG endpoints based on only VF change (n = 74; -0.29 ± 0.31 dB/y) or only optic disc change (n = 158; -0.12 ± 0.19 dB/y) had significantly worse MDRs than non-POAG eyes (both P < 0.001). Eyes that reached POAG endpoints for both VF and optic disc change (n = 127) deteriorated more rapidly (-0.42 ± 0.46 dB/y) than eyes showing only VF change (P = 0.017) or only optic disc change (P < 0.001). There was not a significant association between MDR and original OHTS randomization (observe vs. treat, P = 0.168). CONCLUSIONS: Eyes that develop POAG have significantly worse MDRs than eyes that do not. Eyes that reached endpoints due to both VF and optic disc change had worse MDRs than eyes displaying change in only one of these. MDR was not significantly associated with randomization, suggesting that MDR may not be the best measure of VF change in early-stage POAG. (ClinicalTrials.gov number, NCT00000125.).
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