Ocular Hypertension Treatment Study (OHTS)

NCT ID: NCT00803998

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 1994-02-28
• Study Completion Date: 2006-12-31

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

Conditions

Ocular Hypertension; Glaucoma

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: lead

Principal Investigators

Michael Kass, MD

Role: STUDY_CHAIR

Washington University School of Medicine at St. Louis, St. Louis, Missouri

References

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.

Reference Type: BACKGROUND

PMID: 12049575 (View on PubMed)

Other Identifiers

93.01

Identifier Type: -

Identifier Source: org_study_id