Ocular Hypertension Treatment Study (OHTS)

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-008340
    • Rochester, Minnesota: 15-008340
    NCT ID: NCT00000125
    Sponsor Protocol Number: 5U10EY009341-14

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cheryl Khanna, M.D.

Contact us for the latest status

Contact information:

Heather McLaren-Picciano

(480)301-7147

MclarenPicciano.Heather@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Cheryl Khanna, M.D.

Contact us for the latest status

Contact information:

Jane Sultze

(507)284-5833

Sultze.Jane@mayo.edu

.
CLS-20304520

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