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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01209975
• Other study ID #: SLT-blood flow study
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2010
• Last updated: September 27, 2010
• Start date: November 2008

Study information

• Verified date: September 2010
• Source: University of Toronto
• Contact: Tien Wong
• Phone: 416-603-5694
• Email: twong[@]uhnres.utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Venkataraman ST, Hudson C, Rachmiel R, Buys YM, Markowitz SN, Fisher JA, Trope GE, Flanagan JG. Retinal arteriolar vascular reactivity in untreated and progressive primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):2043-50. doi: 10.1167/iovs.09-3630. Epub 2009 Nov 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood flow	The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow.	before and two-week after SLT	Yes
Secondary	Intraocuclar pressure	Intraocular pressure (IOP) will be measured by Goldmann applanation tonometry.	before and two-week after SLT	Yes