NCT01209975

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

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

November 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

June 29, 2010

Last Update Submit

September 27, 2010

Conditions

Keywords

blood flowglaucomaSLT

Outcome Measures

Primary Outcomes (1)

  • blood flow

    The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow.

    before and two-week after SLT

Secondary Outcomes (1)

  • Intraocuclar pressure

    before and two-week after SLT

Study Arms (1)

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

Interventions

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.

untreated glaucoma patients

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with untreated primary open angle glaucoma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

Related 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.

    PMID: 19907031BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Chris Hudson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2010

First Posted

September 28, 2010

Study Start

November 1, 2008

Primary Completion

November 1, 2011

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations