Recruiting

Dorzolamide

Sponsor:

University Health Network, Toronto

Code:

NCT00152932

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Dorzolamide 2% drops

HRF and CLBF

Study Details

Brief summary:

Impaired ocular blood flow is an important risk factor in the pathogenesis of primary open angle glaucoma (POAG). A few studies suggest that topical dorzolamide 2% may increase optic nerve perfusion. The objectives of this study are to learn the effects of dorzolamide on the retinal and optic nerve blood flow of glaucoma patients.

The present study is a prospective, randomized, double-masked, crossover design study of newly diagnosed or already treated patients with early glaucoma.

The investigators will check ocular blood flow parameters using the Canon Laser Blood Flowmeter (CLBF), used to evaluate retinal arteriole blood flow, and the Heidelberg retinal flowmeter (HRF), which measures blood flow through capillary beds in the retina and optic nerve head.

Any demonstrated improvements to retinal and optic nerve blood flow with dorzolamide, will mean that the drug may protect against ischaemic nerve and retinal damage. Any documented improvement in flow could lead to a major change in the management of glaucoma patients as well as other retinal ischemic diseases such as diabetic retinopathy and central retinal vein occlusion.

Conditions

Glaucoma

Study ID

NCT00152932

Start date

May, 2005

Status verified date

Sep, 2005

Completion date

Jun, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males or females 20-80 years of age.
2. Presence of typical early glaucomatous optic disc changes (cup/disc ratio ≤ 0.75) and/or early glaucomatous visual field defects (mean deviation less than 5dB and outside of 10° from fixation) in the study eye at the baseline visit.
3. Best corrected visual acuity of at least 20/40.
4. Signed informed consent from the subject
5. The subject should be able to understand the instructions and perform the HRF and CLBF tests as well as be willing and able to comply with the study schedule and treatment.

Exclusion Criteria:

1. Pregnant women or nursing mothers.
2. Any other active ocular disease (ocular infections, Uveitis, etc.)
3. Known allergy or sensitivity to the study medications.
4. Functionally significant visual field loss (mean deviation greater than 5dB) or cup/disc ratio greater than 0.75 or evidence of progressive visual field loss within the last 6 months.
5. Required chronic use of other ocular or systemic hypotensive medications during the study, other than the study medication (e.g. beta-blockers, Ca-channel blockers)
6. Vascular occlusive disease affecting the ocular circulation such as: diabetic retinopathy, central retinal vein occlusion, central retinal artery occlusion, or non-arteritic ischemic optic neuropathy.
7. Previous intraocular surgery or ocular traumas.
8. Any past history of serious systemic condition affecting cerebral circulation including: hypertension, diabetes, cerebral vascular accident (CVA), or coronary artery bypass graft (CABG).

Study Design

Enrollment

17 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Dorzolamide 2% drops

HRF and CLBF

Primary outcome measure

  • Ocular blood flow measurements [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Locations

Department of Ophthalmology and Visual Sciences; Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 25, 2007

Last verified

Sep, 2005

Keywords

  • Glaucoma
  • Intraocular pressure
  • Ocular blood flow
  • Laser-Doppler Flowmetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2007-07-25.