Ocular Blood Flow in Early Glaucoma Patients Before and After Treatment With Dorzolamide

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152932
First received: September 8, 2005
Last updated: July 23, 2007
Last verified: September 2005
  Purpose

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.


Condition Intervention
Glaucoma
Drug: Dorzolamide 2% drops
Device: HRF and CLBF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Ocular Blood Flow Measured by HRF and CLBF in Newly Diagnosed and Early Glaucoma Patients Before and After Instillation of Dorzolamide 2%

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Ocular blood flow measurements

Secondary Outcome Measures:
  • Intraocular pressure reduction

Estimated Enrollment: 17
Study Start Date: May 2005
Estimated Study Completion Date: June 2006
Detailed Description:

High intraocular pressure (IOP) is the major risk factor for glaucoma. Lowering intraocular pressure is still the only accepted form of treatment for glaucoma.

Over the past decade, epidemiological and experimental evidence suggested that impaired ocular blood flow is an important risk factor with an important role in the pathogenesis of primary open angle glaucoma (POAG). Several studies suggest that ischemia-promoting vascular factors may contribute to glaucomatous damage including vasospasm, impaired ocular perfusion pressure and general vascular disorders such as low blood pressure, especially dips in blood pressure at night.

Different techniques are employed to assess vascular dysfunction in the eye. As the methodology of ocular blood flow assessment is complex and differs in various aspects (e.g. target tissue and physiological parameters), comparative studies are required in order to enhance the interpretation of these measurements.

Our laboratory has state of the art equipment to assess ocular blood flow. One study done by us suggested that one drop of Dorzolamide 2% does not improve retinal blood flow in normal eyes. In the present study we plan to extend this study to 2 weeks of treatment in patients with POAG.

Dorzolamide hydrochloride 2% is a topical carbonic anhydrase inhibitor which reduces intraocular pressure (IOP) by decreasing the production of aqueous humour. Pharmacological studies on volunteers and glaucoma patients, using Color Doppler Imaging (measuring the retrobulbar blood flow) and Scanning laser Ophthalmoscopy (measuring arteriovenous passage time), indicate that topically applied Dorzolamide may increase perfusion of the optic nerve and peripapillary retina.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152932

Contacts
Contact: Rony Rachmiel, MD 416-603-5317 rachmiel_r@hotmail.com

Locations
Canada, Ontario
Department of Ophthalmology and Visual Sciences; Toronto Western Hospital Recruiting
Toronto, Ontario, Canada
Contact: Rony Rachmiel, MD    416-603-5317    rachmiel_r@hotmail.com   
Contact: Graham E Trope, MB PhD, FRCSC    416-603-5317    Graham.Trope@uhn.on.ca   
Sub-Investigator: Rony Rachmiel, MD         
Sponsors and Collaborators
University Health Network, Toronto
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Graham E Trope, MB, FRCSC University of Toronto, Department of Ophthalmology
Study Chair: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00152932     History of Changes
Other Study ID Numbers: 04-0645-A
Study First Received: September 8, 2005
Last Updated: July 23, 2007
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Glaucoma
Intraocular pressure
Ocular blood flow
Laser-Doppler Flowmetry

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Dorzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014