Retinal Vascular Reactivity in Subjects With Newly Diagnosed Glaucoma Before and After Selective Laser Trabeculoplasty

September 27, 2010 updated by: University of Toronto

Retinal Vascular Reactivity in Response to Isoxic Hypercapnia in Subjects With Newly Diagnosed Glaucoma

The purpose of this study is to assess retinal blood flow and vascular reactivity in patients with newly diagnosed primary open angle glaucoma pre- and post-primary Selective Laser Trabeculoplasty(SLT). Canon Laser Blood Flowmeter will be used for the assessment of retinal blood flow.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We previously found that vascular reactivity improved after short term treatment with dorzolamide drops. It is not clear whether this improvement was a direct effect of the medication or secondary effect of the decrease in IOP. We would like to see the change of vascular reactivity before and after SLT, which will decrease the intraocular pressure without pharmacologic effect.

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient with untreated primary open angle glaucoma

Description

Inclusion Criteria:

  1. Age 40-75 years (Male or Female)
  2. Best corrected visual acuity of at least 20/40
  3. No previous treatment for glaucoma
  4. Ametropia less than ±6.0 DS and ±2.5 DC)
  5. Non-smoker
  6. No cardiovascular/respiratory disorders

Exclusion Criteria:

  1. Past history of diabetes and cerebrovascular accident
  2. Vascular occlusive disease affecting the ocular circulation such as: diabetic retinopathy, retinal vein occlusion and retinal artery occlusion
  3. Previous intraocular surgery
  4. Ocular media opacities limiting the use of the imaging tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
untreated glaucoma patients
We will evaluate the blood flow before and after Selective Laser Trabeculoplasty in patients with primary open angel glaucoma.
Procedure: Selective Laser Trabeculoplasty
Patient will have selective laser trabeculoplasty as the first treatment for glaucoma. This treatment will be dictated clinically, since we do not assign the interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood flow
Time Frame: before and two-week after SLT
The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow.
before and two-week after SLT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocuclar pressure
Time Frame: before and two-week after SLT
Intraocular pressure (IOP) will be measured by Goldmann applanation tonometry.
before and two-week after SLT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Chris Hudson, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (ESTIMATE)

September 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2010

Last Update Submitted That Met QC Criteria

September 27, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLT-blood flow study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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