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Delaying Treatment of Ocular HypertensionThe Ocular Hypertension Treatment Study
Michael A. Kass, MD;
Mae O. Gordon, PhD;
Feng Gao, PhD;
Dale K. Heuer, MD;
Eve J. Higginbotham, MD;
Chris A. Johnson, PhD;
John K. Keltner, MD;
J. Philip Miller, BS;
Richard K. Parrish, MD;
M. Roy Wilson, MD; for the Ocular Hypertension Treatment Study Group
Arch Ophthalmol. 2010;128(3):276-287. doi:10.1001/archophthalmol.2010.20
Objective To compare the safety and efficacy of earlier vs later treatment in preventing primary open-angle glaucoma (POAG) in individuals with ocular hypertension.
Methods One thousand six hundred thirty-six individuals with intraocular pressure (IOP) from 24 to 32 mm Hg in 1 eye and 21 to 32 mm Hg in the fellow eye were randomized to observation or to topical ocular hypotensive medication. Median time of treatment in the medication group was 13.0 years. After a median of 7.5 years without treatment, the observation group received medication for a median of 5.5 years. To determine if there is a penalty for delaying treatment, we compared the cumulative proportions of participants who developed POAG at a median follow-up of 13 years in the original observation group and in the original medication group.
Main Outcome Measures Cumulative proportion of participants who developed POAG.
Results The cumulative proportion of participants in the original observation group who developed POAG at 13 years was 0.22 (95% confidence interval [CI], 0.19-0.25), vs 0.16 (95% CI, 0.13-0.19) in the original medication group (P = .009). Among participants at the highest third of baseline risk of developing POAG, the cumulative proportion who developed POAG was 0.40 (95% CI, 0.33-0.46) in the original observation group and 0.28 (95% CI, 0.22-0.34) in the original medication group. There was little evidence of increased adverse events associated with medication.
Application to Clinical Practice Absolute reduction was greatest among participants at the highest baseline risk of developing POAG. Individuals at high risk of developing POAG may benefit from more frequent examinations and early preventive treatment.
Trial Registration clinicaltrials.gov Identifier: NCT00000125
Author Affiliations: Department of Ophthalmology and Visual Sciences (Drs Kass and Gordon), and Division of Biostatistics (Dr Gao and Mr Miller), Washington University School of Medicine, St Louis, Missouri; Department of Ophthalmology, Medical College of Wisconsin, Milwaukee (Dr Heuer); Morehouse School of Medicine, Atlanta, Georgia (Dr Higginbotham); Department of Ophthalmology, University of Iowa Hospitals and Clinics, Iowa City (Dr Johnson); Department of Ophthalmology and Vision Science, University of California–Davis, Davis (Dr Keltner); Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida (Dr Parrish); and University of Colorado–Denver, Denver (Dr Wilson).
Group Information: A list of the Ocular Hypertension Treatment Study Group members was published in Arch Ophthalmol. 2002;120(6):701-713.
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