Glaucoma is one of the leading causes of blindness in the United States and other industrialized countries. In fact, glaucoma is now recognized to be the number one cause of blindness in African Americans. Elevated intraocular pressure (IOP) is a common condition and is thought to be the leading risk factor for the development of open-angle glaucoma. There is conflicting evidence as to whether early medical treatment is effective in preventing or delaying the onset of glaucomatous damage in individuals with elevated intraocular pressure (referred to as ocular hypertensive individuals or glaucoma suspects). The proposed study is a long-term, randomized, multicenter, single-masked clinical trial to determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous optic nerve and/or visual field damage in ocular hypertensive subjects. 1,500 subjects with IOP's greater than or equal to 24 mm Hg but less than or equal to 32 mm Hg in at least one eye (IOP's greater than or equal to 21 mm HG in the fellow eye) as determined by two consecutive measurements at least 2 hours, but not greater than 12 weeks, apart and normal visual fields and optic discs in both eyes will be assigned randomly to receive stepped medical treatment to both eyes or to close observation only to both eyes. Because of this level of intraocular pressure, the subjects are considered to be at moderate risk for the development of open- angle glaucoma. The subjects will be followed twice yearly with automated, threshold, central, static perimetry (Humphrey program 30-2) and once yearly with stereoscopic optic disc photographs. The study endpoints are progressive optic disc damage and/or reproducible glaucomatous visual field loss in either eye of a patient. All visual fields and optic disc photographs will be read in masked fashion in Reading Centers. While this trial is designed to study the efficacy and safety of early medical treatment in ocular hypertension, there will be other benefits as well. This study will allow us to refine and validate estimates of risk for individual ocular hypertensive patients in a large national sample. Furthermore, this study will also determine the conversion rate of African American ocular hypertensive subjects to open-angle glaucoma. At the conclusion of this study, practitioners should be able to make reasonable estimates of risk for individual ocular hypertensive patients and determine which ocular hypertensive individuals are most likely to benefit from early prophylactic medical treatment. The Study Chairman's Office and the Data Coordinating Center will be at Washington University. The Visual Field Reading Center will be at U.C.- Davis and the Optic Disc Reading Center at Yale University. The various Clinical Centers will be chosen by the NEI using an RFA mechanism at a later time.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY009307-10
Application #
6476393
Study Section
Vision Research and Training Committee (VSN)
Program Officer
Everett, Donald F
Project Start
1992-09-30
Project End
2003-11-30
Budget Start
2001-12-01
Budget End
2002-11-30
Support Year
10
Fiscal Year
2002
Total Cost
$1,720,579
Indirect Cost
Name
Washington University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
062761671
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
Budenz, Donald L; Huecker, Julia Beiser; Gedde, Steven J et al. (2017) Thirteen-Year Follow-up of Optic Disc Hemorrhages in the Ocular Hypertension Treatment Study. Am J Ophthalmol 174:126-133
Scheetz, Todd E; Faga, Ben; Ortega, Lizette et al. (2016) Glaucoma Risk Alleles in the Ocular Hypertension Treatment Study. Ophthalmology 123:2527-2536
Song, Christian; De Moraes, Carlos Gustavo; Forchheimer, Ilana et al. (2014) Risk calculation variability over time in ocular hypertensive subjects. J Glaucoma 23:1-4
Anderson, Andrew J; Stainer, Matthew J (2014) A control experiment for studies that show improved visual sensitivity with intraocular pressure lowering in glaucoma. Ophthalmology 121:2028-32
Kummet, Colleen M; Zamba, K D; Doyle, Carrie K et al. (2013) Refinement of pointwise linear regression criteria for determining glaucoma progression. Invest Ophthalmol Vis Sci 54:6234-41
Gardiner, Stuart K; Demirel, Shaban; Gordon, Mae O et al. (2013) Seasonal changes in visual field sensitivity and intraocular pressure in the ocular hypertension treatment study. Ophthalmology 120:724-30
Gardiner, Stuart K; Demirel, Shaban; De Moraes, Carlos Gustavo et al. (2013) Series length used during trend analysis affects sensitivity to changes in progression rate in the ocular hypertension treatment study. Invest Ophthalmol Vis Sci 54:1252-9
Zangwill, Linda M; Jain, Sonia; Dirkes, Keri et al. (2013) The rate of structural change: the confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study. Am J Ophthalmol 155:971-82
De Moraes, Carlos Gustavo; Demirel, Shaban; Gardiner, Stuart K et al. (2012) Effect of treatment on the rate of visual field change in the ocular hypertension treatment study observation group. Invest Ophthalmol Vis Sci 53:1704-9
De Moraes, Carlos Gustavo; Demirel, Shaban; Gardiner, Stuart K et al. (2012) Rate of visual field progression in eyes with optic disc hemorrhages in the ocular hypertension treatment study. Arch Ophthalmol 130:1541-6

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