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Original Investigation
April 15, 2021

Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up

Author Affiliations
  • 1Washington University School of Medicine in St Louis, St Louis, Missouri
  • 2David Geffen School of Medicine, Los Angeles, California
  • 3Office of Inclusion and Diversity, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  • 4Bascom Palmer Eye Institute, Miami, Florida
  • 5Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota
  • 6Davis Eye Center, University of California, Davis, Davis
  • 7University of Louisville, Louisville, Kentucky
  • 8University of Iowa, Iowa City
  • 9University of California, Davis, Davis
  • 10Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 11Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri
JAMA Ophthalmol. Published online April 15, 2021. doi:10.1001/jamaophthalmol.2021.0341
Key Points

Question  Do 20-year follow-up data from the Ocular Hypertension Treatment Study inform the management of patients with ocular hypertension?

Findings  In this cohort study of 1636 participants with ocular hypertension who participated in the Ocular Hypertension Treatment Study, the 20-year cumulative incidence of primary open-angle glaucoma was 46% in 1 or both eyes, and the cumulative incidence of visual field loss was 25% after adjusting for exposure time.

Meaning  This study’s findings, together with a predictive model, may help clinicians and patients make informed personalized decisions about the management of ocular hypertension.

Abstract

Importance  Ocular hypertension is an important risk factor for the development of primary open-angle glaucoma (POAG). Data from long-term follow-up can be used to inform the management of patients with ocular hypertension.

Objective  To determine the cumulative incidence and severity of POAG after 20 years of follow-up among participants in the Ocular Hypertension Treatment Study.

Design, Setting, and Participants  Participants in the Ocular Hypertension Treatment Study were followed up from February 1994 to December 2008 in 22 clinics. Data were collected after 20 years of follow-up (from January 2016 to April 2019) or within 2 years of death. Analyses were performed from July 2019 to December 2020.

Interventions  From February 28, 1994, to June 2, 2002 (phase 1), participants were randomized to receive either topical ocular hypotensive medication (medication group) or close observation (observation group). From June 3, 2002, to December 30, 2008 (phase 2), both randomization groups received medication. Beginning in 2009, treatment was no longer determined by study protocol. From January 7, 2016, to April 15, 2019 (phase 3), participants received ophthalmic examinations and visual function assessments.

Main Outcomes and Measures  Twenty-year cumulative incidence and severity of POAG in 1 or both eyes after adjustment for exposure time.

Results  A total of 1636 individuals (mean [SD] age, 55.4 [9.6] years; 931 women [56.9%]; 1138 White participants [69.6%]; 407 Black/African American participants [24.9%]) were randomized in phase 1 of the clinical trial. Of those, 483 participants (29.5%) developed POAG in 1 or both eyes (unadjusted incidence). After adjusting for exposure time, the 20-year cumulative incidence of POAG in 1 or both eyes was 45.6% (95% CI, 42.3%-48.8%) among all participants, 49.3% (95% CI, 44.5%-53.8%) among participants in the observation group, and 41.9% (95% CI, 37.2%-46.3%) among participants in the medication group. The 20-year cumulative incidence of POAG was 55.2% (95% CI, 47.9%-61.5%) among Black/African American participants and 42.7% (95% CI, 38.9%-46.3%) among participants of other races. The 20-year cumulative incidence for visual field loss was 25.2% (95% CI, 22.5%-27.8%). Using a 5-factor baseline model, the cumulative incidence of POAG among participants in the low-, medium-, and high-risk tertiles was 31.7% (95% CI, 26.4%-36.6%), 47.6% (95% CI, 41.6%-53.0%), and 59.8% (95% CI, 53.1%-65.5%), respectively.

Conclusions and Relevance  In this study, only one-fourth of participants in the Ocular Hypertension Treatment Study developed visual field loss in either eye over long-term follow-up. This information, together with a prediction model, may help clinicians and patients make informed personalized decisions about the management of ocular hypertension.

Trial Registration  ClinicalTrials.gov Identifier: NCT00000125.

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