Back to resultsOcular Hypertension Treatment Study (OHTS)
Primary Purpose
Ocular Hypertension, Glaucoma
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Qualifying IOP in at least one eye of each participant must be more than or equal 24 mmHg but less than or equal to 32 mm HG calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart.
- Normal and reliable 30-2 Humphrey Visual Fields in both eyes.
- Normal Optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the Optic Disc Reading Center.
Exclusion Criteria:
- Visual acuity worse than 20/40 in either eye on qualifying exam.
- Previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00803998
First Posted
December 5, 2008
Last Updated
October 31, 2013
Sponsor
The New York Eye & Ear Infirmary
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00803998
Brief Title
Ocular Hypertension Treatment Study (OHTS)
Official Title
Ocular Hypertension Treatment Study
Study Type
Observational
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The New York Eye & Ear Infirmary
Collaborators
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the National Eye Institute, designed to determine the efficacy and safety of topically administered eye lowering medication
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Qualifying IOP in at least one eye of each participant must be more than or equal 24 mmHg but less than or equal to 32 mm HG calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart.
Normal and reliable 30-2 Humphrey Visual Fields in both eyes.
Normal Optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the Optic Disc Reading Center.
Exclusion Criteria:
Visual acuity worse than 20/40 in either eye on qualifying exam.
Previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kass, MD
Organizational Affiliation
Washington University School of Medicine at St. Louis, St. Louis, Missouri
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
12049575
Citation
Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
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Ocular Hypertension Treatment Study (OHTS)
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