TY - JOUR
T1 - 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
AU - Ocular Hypertension Study Group
AU - Kass, Michael A.
AU - Heuer, Dale K.
AU - Higginbotham, Eve J.
AU - Parrish, Richard K.
AU - Khanna, Cheryl L.
AU - Brandt, James D.
AU - Soltau, Joern B.
AU - Johnson, Chris A.
AU - Keltner, John L.
AU - Huecker, Julia B.
AU - Wilson, Bradley S.
AU - Liu, Lei
AU - Miller, J. Phillip
AU - Quigley, Harry A.
AU - Gordon, Mae O.
N1 - Funding Information:
Funding/Support: This study was supported by
Funding Information:
receiving grants from Merck, the National Institutes of Health, Pfizer, and Research to Prevent Blindness during the conduct of the study and owning stock options in Smartlens outside the submitted work. Dr Heuer reported receiving personal fees from Washington University as a subcontractor for the National Eye Institute and the National Institutes of Health during the conduct of the study and receiving personal fees from Advanced Clinical (for serving as consultant to Google) and InnFocus outside the submitted work. Dr Higginbotham reported receiving grants from the National Eye Institute and being a subcontractor for Washington University during the conduct of the study. Ms Huecker reported receiving grants from the National Eye Institute during the conduct of the study and outside the submitted work. Mr Wilson reported receiving grants from the National Eye Institute during the conduct of the study. Dr Liu reported receiving grants from the National Institutes of Health during the conduct of the study and receiving consulting fees from Mesoblast outside the submitted work. Mr Miller reported receiving grants from the National Institutes of Health during the conduct of the study and receiving grants from the National Institutes of Health and the Patient-Centered Outcomes Research Institute and personal fees from General Dynamics (US Department of Defense) and the National Institutes of Health outside the submitted work. Dr Brandt reported receiving grants from the National Eye Institute during the conduct of the study and receiving consulting fees from Aerie
Publisher Copyright:
© 2021 American Medical Association.
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85104446568&partnerID=8YFLogxK
U2 - 10.1001/jamaophthalmol.2021.0341
DO - 10.1001/jamaophthalmol.2021.0341
M3 - Article
C2 - 33856434
AN - SCOPUS:85104446568
SN - 2168-6165
VL - 139
SP - 558
EP - 566
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
IS - 5
ER -