NCT00152932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 25, 2007

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

July 23, 2007

Conditions

Glaucoma

Keywords

GlaucomaIntraocular pressureOcular blood flowLaser-Doppler Flowmetry

Outcome Measures

Primary Outcomes (1)

  • Ocular blood flow measurements

Secondary Outcomes (1)

  • Intraocular pressure reduction

Interventions

Dorzolamide 2% dropsDRUG
HRF and CLBFDEVICE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 20-80 years of age.
  • 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.
  • Best corrected visual acuity of at least 20/40.
  • Signed informed consent from the subject
  • 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.

You may not qualify if:

  • Pregnant women or nursing mothers.
  • Any other active ocular disease (ocular infections, Uveitis, etc.)
  • Known allergy or sensitivity to the study medications.
  • 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.
  • 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)
  • 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.
  • Previous intraocular surgery or ocular traumas.
  • Any past history of serious systemic condition affecting cerebral circulation including: hypertension, diabetes, cerebral vascular accident (CVA), or coronary artery bypass graft (CABG).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology and Visual Sciences; Toronto Western Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Graham E Trope, MB, FRCSC

    University of Toronto, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

  • Chris Hudson, PhD

    Department of Ophthalmology, Toronto Western Hospital, Toronto

    STUDY CHAIR

  • John Flanagan, PhD

    Department of Ophthalmology, Toronto Western Hospital, Toronto

    STUDY CHAIR

  • Yvonne M Buys, MD, FRCSC

    University of Toronto, Department of Ophthalmology, Toronto Western Hospital, Toronto

    STUDY CHAIR

Central Study Contacts

Rony Rachmiel, MD

CONTACT

416-603-5317rachmiel_r@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

May 1, 2005

Study Completion

June 1, 2006

Last Updated

July 25, 2007

Record last verified: 2005-09

Locations

CA(1)