2021 Apr 15 DOI: 10.1001/jamaophthalmol.2021.0341 https://pubmed.ncbi.nlm.nih.gov/33856434/
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.
Additional information:
483 participants (29.5%) in this study developed primary open-angle glaucoma in 1 or both eyes. That is the unadjusted incidence. The next paragraph provides better insights into the study results.
After the research team adjusted for exposure time, the 20-year cumulative incidence of the disease in 1 or both eyes was 45.6% among the entire patient population.
This broke down to 49.3% among participants in the observation group and 41.9% among participants in the medication group.
In addition, 20-year cumulative incidence of primary open-angle glaucoma was 55.2% among African American participants and 42.7% among participants of other races.
Therefore, a better headline might be "20-year glaucoma follow-up finds glaucoma in nearly half of all patients." That paints an entirely different picture.
The researchers also used a 5-factor baseline model and found the cumulative incidence of disease among participants was:
- low-risk tertile: 31.7%
- medium-risk tertile: 47.6%
- high-risk tertile: 59.8%
The full text article is not yet available (at the time I posted this). We need the full text to determine the non-IOP risk factors associated with the participants in this study.