Ocular Hypertension Treatment Study (OHTS)

Overview

About this study

To determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive participants judged to be at moderate risk for developing open-angle glaucoma. To produce natural history data to assist in identifying patients at most risk for developing open-angle glaucoma and those most likely to benefit from early medical treatment. To quantify risk factors for developing open-angle glaucoma among ocular hypertensive individuals.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Men and nonpregnant women between the ages of 40 and 80 
  • IOP greater than or equal to 24 mm Hg but less than or equal to 32 mm Hg in at least one eye and IOP greater than or equal to 21 but less than or equal to 32 mm Hg in the fellow eye
  •  Normal visual fields
  • Optic discs are eligible for the trial

Exclusion Criteria:

  • Patients presenting with best-corrected visual acuity worse than 20/40 in either eye
  • Previous intraocular surgery
  • A life-threatening or debilitating disease
  • Secondary causes of elevated IOP
  • Angle-closure glaucoma or anatomically narrow angles
  • Other diseases that can cause visual field loss
  • Background diabetic retinopathy
  • Optic disc abnormalities that can produce visual field loss or obscure the interpretation of the optic disc
  • Unwillingness to undergo random assignment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cheryl Khanna, M.D.

Closed for enrollment

Contact information:

Heather McLaren-Picciano

(480)301-7147

MclarenPicciano.Heather@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Cheryl Khanna, M.D.

Closed for enrollment

Contact information:

Jane Sultze CCRP

(507)538-5523

Sultze.Jane@mayo.edu

More information

Publications

  • To identify objective, quantitative optic nerve head (ONH) structural features and model the contributions of glaucoma. Read More on PubMed
  • To explore the association between peripapillary atrophy (PPA) area and conversion from ocular hypertension (OHT) to glaucoma. Read More on PubMed
  • To compare rates of topographic change in ocular hypertensive eyes that develop primary open-angle glaucoma (POAG) compared to eyes that do not, and to identify factors that influence the rate of change. Read More on PubMed
  • Longitudinal testing plays a key role in glaucoma management. Variability between visits hampers the ability to monitor progression. It has previously been shown that average intraocular pressure (IOP) exhibits seasonal fluctuations. This study examines whether visual field sensitivity also exhibits seasonal fluctuations and seeks to determine whether such fluctuations are correlated to seasonal IOP effects. Read More on PubMed
  • Trend analysis techniques to detect glaucomatous progression typically assume a constant rate of change. This study uses data from the Ocular Hypertension Treatment Study to assess whether this assumption decreases sensitivity to changes in progression rate, by including earlier periods of stability. Read More on PubMed
  • To compare rates of visual field (VF) change in ocular hypertensive eyes with and without optic dischemorrhage (DH). Read More on PubMed
  • To determine the change in intraocular pressure (IOP) after cataract extraction in the observation group of the Ocular Hypertension Treatment Study. Read More on PubMed
  • To create and validate a statistical model predicting progression of primary open-angle glaucoma (POAG) assessed by loss of visual field as measured in mean deviation (MD) using 3 landmark studies of glaucoma progression and treatment. Read More on PubMed
  • The goal in this study was to compare rates of visual field (VF) change before and after the initiation of treatment in participants originally randomized to the observation arm of the Ocular Hypertension Treatment Study (OHTS). Read More on PubMed
  • To determine if the accuracy of the baseline prediction model for the development of primary open-angle glaucoma (POAG) in patients with ocular hypertension can be improved by correcting intraocular pressure (IOP) for central corneal thickness (CCT). Read More on PubMed
  • To assess the rate of change of visual field (VF) mean deviation (MD) in the Ocular Hypertension Treatment Study (OHTS). Read More on PubMed
  • Primary open-angle glaucoma (POAG) is among the leading causes of blindness in the United States and worldwide. While numerous prospective clinical trials have convincingly shown that elevated intraocular pressure (IOP) is a leading risk factor for the development of POAG, an increasingly debated issue in recent years is the effect of IOP fluctuation on the risk of developing POAG. In many applications, this question is addressed via a "naïve" two-step approach where some sample-based estimates (e.g., standard deviation) are first obtained as surrogates for the "true" within-subject variability and then included in Cox regression models as covariates. However, estimates from two-step approach are more likely to suffer from the measurement error inherent in sample-based summary statistics. In this paper we propose a joint model to assess the question whether individuals with different levels of IOP variability have different susceptibility to POAG. In our joint model, the trajectory of IOP is described by a linear mixed model that incorporates patient-specific variance, the time to POAG is fit using a semi-parametric or parametric distribution, and the two models are linked via patient-specific random effects. Parameters in the joint model are estimated under Bayesian framework using Markov chain Monte Carlo (MCMC) methods with Gibbs sampling. The method is applied to data from the Ocular Hypertension Treatment Study (OHTS) and the European Glaucoma Prevention Study (EGPS), two large-scale multi-center randomized trials on the prevention of POAG. Read More on PubMed
  • In some clinical trials and epidemiologic studies, investigators are interested in knowing whether the variability of a biomarker is independently predictive of clinical outcomes. This question is often addressed via a naïve approach where a sample-based estimate (e.g., standard deviation) is calculated as a surrogate for the "true" variability and then used in regression models as a covariate assumed to be free of measurement error. However, it is well known that the measurement error in covariates causes underestimation of the true association. The issue of underestimation can be substantial when the precision is low because of limited number of measures per subject. The joint analysis of survival data and longitudinal data enables one to account for the measurement error in longitudinal data and has received substantial attention in recent years. In this paper we propose a joint model to assess the predictive effect of biomarker variability. The joint model consists of two linked sub-models, a linear mixed model with patient-specific variance for longitudinal data and a full parametric Weibull distribution for survival data, and the association between two models is induced by a latent Gaussian process. Parameters in the joint model are estimated under Bayesian framework and implemented using Markov chain Monte Carlo (MCMC) methods with WinBUGS software. The method is illustrated in the Ocular Hypertension Treatment Study to assess whether the variability of intraocular pressure is an independent risk of primary open-angle glaucoma. The performance of the method is also assessed by simulation studies. Read More on PubMed
  • To assess agreement between longitudinal and cross-sectional analyses for determining visual field progression in data from the Ocular Hypertension Treatment Study. Read More on PubMed
  • To determine whether adjusting the intraocular pressure (IOP) change of the trial eye for the IOP change of the fellow eye (i.e., monocular trial) is a better assessment of medication response than testing each eye independently. Read More on PubMed
  • To evaluate the predictive ability of baseline confocal scanning laser ophthalmoscopy (CSLO) Glaucoma Probability Score (GPS) for the development of primary open-angle glaucoma (POAG) and to compare it with the Moorfields regression analysis (MRA) classification, other topographic optic disc parameters, and stereophotograph-based cup-to-disc ratio. Read More on PubMed
  • To assess the influence of expected life span on the cost-effectiveness of treating ocular hypertension to prevent primary open-angle glaucoma. Read More on PubMed
  • To determine the incidence of retinal vein occlusion (RVO) in the Ocular Hypertension Treatment Study (OHTS). Read More on PubMed
  • To describe variability of intraocular pressure (IOP) measurements within the same eye and between right and left eyes over a 60-month period in participants in the Ocular Hypertension Treatment Study. Read More on PubMed
  • This report compares the accuracy of 3 prediction models for the development of primary open-angle glaucoma (POAG). The models differ primarily in their handling of these eye-specific variables: intraocular pressure (IOP), central corneal thickness (CCT), vertical cup-to-disc ratio (VCD), and visual field pattern standard deviation (PSD). The "means" model includes age and the means of right and left eyes; the "means plus asymmetry" model includes age, the means of right and left eyes as well as the absolute difference between eyes for eye-specific variables; and the "worse" eye model includes age and values from the eye at higher risk for developing POAG. Read More on PubMed
  • To describe how much change, if any, occurs between central corneal thickness (CCT) measurements performed an average of 3.8 years apart in participants in the Ocular Hypertension Treatment Study (OHTS) and to identify clinical and demographic factors that are associated with changes in CCT, including baseline intraocular pressure, duration and class of ocular hypotensive medication, medical history, and systemic medication. Read More on PubMed
  • To report the impact of visual field quality control (QC) procedures on the rates of visual field unreliability, test parameter errors, and visual field defects attributed to testing artifacts in the Ocular Hypertension Treatment Study (OHTS). Read More on PubMed
  • To compare the intraocular pressure (IOP) responses of self-identified African American and white participants in the Ocular Hypertension Treatment Study to therapeutic trials of topical, nonselective beta-adrenergic antagonists or prostaglandin analogues. Read More on PubMed
  • To test the validity and generalizability of the Ocular Hypertension Treatment Study (OHTS) prediction model for the development of primary open-angle glaucoma (POAG) in a large independent sample of untreated ocular hypertensive individuals and to develop a quantitative calculator to estimate the 5-year risk that an individual with ocular hypertension will develop POAG. Read More on PubMed
  • To compare the rates of detection of optic disc hemorrhages by clinical examination and by review of optic disc photographs at the Optic Disc Reading Center (ODRC), to assess the incidence of and the predictive factors for disc hemorrhages in the annual disc photographs of the Ocular Hypertension Treatment Study (OHTS), and to determine whether optic disc hemorrhages predict the development of primary open-angle glaucoma (POAG) in the OHTS. Read More on PubMed
  • To determine whether topical ocular hypotensive medication is associated with refractive changes, visual symptoms, decreased visual function, or increased lens opacification. Read More on PubMed
  • To compare subbasal corneal nerve and keratocyte density and endothelial characteristics of ocular hypertensive patients treated with medications or observation. Read More on PubMed
  • To evaluate whether baseline visual field data and asymmetries between eyes predict the onset of primary open-angle glaucoma (POAG) in Ocular Hypertension Treatment Study (OHTS) participants. Read More on PubMed
  • To determine the association between change from baseline in the optic nerve head (ONH) and the visual field (VF) during follow-up of ocular hypertension participants in the Ocular Hypertension Treatment Study. Read More on PubMed
  • The Ocular Hypertension Treatment Study (OHTS) demonstrated that medical treatment of people with intraocular pressure (IOP) of > or =24 mm Hg reduces the risk of the development of primary open-angle glaucoma (POAG) by 60%. There is no consensus on which people with ocular hypertension would benefit from treatment. Read More on PubMed
  • To assess the reproducibility of determining whether an eye has developed optic disk deterioration by the Optic Disc Reading Center (ODRC) in the Ocular Hypertension Treatment Study (OHTS). Read More on PubMed
  • To determine whether baseline confocal scanning laser ophthalmoscopy (CSLO) optic disc topographic measurements are associated with the development of primary open-angle glaucoma (POAG) in individuals with ocular hypertension. Read More on PubMed
  • To compare the occurrence of normal visual field (VF) test results following 2 vs 3 consecutive, abnormal, reliable test results in the Ocular Hypertension Treatment Study. Read More on PubMed
  • To determine whether central corneal thickness (CCT) correlates with measured intraocular pressure (IOP) response to topical ocular hypotensive medication in the Ocular Hypertension Treatment Study (OHTS). Read More on PubMed
  • Higher baseline pattern standard deviation (PSD) and larger vertical cup-to-disk ratio (VC/D) were factors in the predictive model for the development of primary open-angle glaucoma (POAG) in the Ocular Hypertension Treatment Study. Because early changes in PSD and VC/D may be indicative of early POAG damage, we repeated the prediction model excluding PSD and VC/D. Read More on PubMed
  • The prevalence of glaucoma is higher in African American individuals than in white individuals. Read More on PubMed
  • To describe the study design of the Confocal Scanning Laser Ophthalmoscopy (CSLO) Ancillary Study to the Ocular Hypertension Treatment Study (OHTS) and to examine the associations between optic disk topography, and baseline demographic, clinical, and ocular factors at study entry. Read More on PubMed
  • To examine racial differences in optic disc topography among ocular hypertensive participants in the Ocular Hypertension Treatment Study. Read More on PubMed
  • (1) To develop a classification system for visual field (VF) abnormalities, (2) to determine interreader and test-retest agreement, and (3) to determine the frequency of various VF defects in the Ocular Hypertension Treatment Study. Read More on PubMed
  • Primary open-angle glaucoma (POAG) is one of the leading causes of blindness in the United States and worldwide. Three to 6 million people in the United States are at increased risk for developing POAG because of elevated intraocular pressure (IOP), or ocular hypertension. There is no consensus on the efficacy of medical treatment in delaying or preventing the onset of POAG in individuals with elevated IOP. Therefore, we designed a randomized clinical trial, the Ocular Hypertension Treatment Study. Read More on PubMed
  • The Ocular Hypertension Treatment Study (OHTS) has shown that topical ocular hypotensive medication is effective in delaying or preventing the onset of primary open-angle glaucoma (POAG) in individuals with elevated intraocular pressure (ocular hypertension) and no evidence of glaucomatous damage. Read More on PubMed
  • The Ocular Hypertension Treatment Study (OHTS) seeks to evaluate the safety and efficacy of topical ocular hypotensive medication in preventing or delaying the onset of visual field loss and/or optic nerve damage in ocular hypertensive subjects at risk for developing primary open-angle glaucoma. This study evaluates the baseline visual field test characteristics (visual field status, reliability properties, etc.) of patients who underwent eligibility visual field testing for entry to the OHTS. Read More on PubMed
  • To determine the reproducibility over time of visual estimates of the horizontal cup/disk ratio by trained technicians from optic disk stereophotographs. Read More on PubMed
  • Central corneal thickness influences intraocular pressure (IOP) measurement. We examined the central corneal thickness of subjects in the Ocular Hypertension Treatment Study (OHTS) and determined if central corneal thickness is related to race. Read More on PubMed
  • To evaluate the magnitude of the contralateral effect of topically administered beta-blockers on intraocular pressure. Read More on PubMed
  • To determine the frequency with which visual field abnormalities observed on follow-up visual fields for patients in the Ocular Hypertension Treatment Study were confirmed on retest. Read More on PubMed
  • The Ocular Hypertension Treatment Study (OHTS) seeks to evaluate the safety and efficacy of topical ocular hypotensive medication in preventing or delaying the onset of visual field loss and/or optic nerve damage in subjects with ocular hypertension at moderate risk for developing primary open angle glaucoma. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20304520

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