GlaucomaNCT01209975
Retinal Vascular Reactivity in Subjects With Newly Diagnosed Glaucoma Before and After Selective Laser Trabeculoplasty
An observational study of Glaucoma, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Selective Laser Trabeculoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with untreated primary open angle glaucoma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Tien Wong, 416-603-5694, twong@uhnres.utoronto.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Selective Laser Trabeculoplasty
- Keywords
- blood flow, glaucoma, SLT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Laser TrabeculoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| untreated glaucoma patients | We will evaluate the blood flow before and after Selective Laser Trabeculoplasty in patients with primary open angel glaucoma. Receives: Procedure: Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood flow
The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow.
Measured: before and two-week after SLT
Secondary outcomes (1)
Intraocuclar pressure
Intraocular pressure (IOP) will be measured by Goldmann applanation tonometry.
Measured: before and two-week after SLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startNov 2008
- Primary completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Investigators
- Chris Hudson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209975
- Sponsor's protocol ID
- SLT-blood flow study
- Status last verified
- Sep 2010
- First submitted
- 29 Jun 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19907031
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vascular Reactivity in Response to Isoxic Hypercapnia in Subjects With Newly Diagnosed Glaucoma
- ClinicalTrials.gov ID
- NCT01209975
- Acronym / sponsor ID
- SLT-blood flow study
- Conditions
- Glaucoma
- Keywords
- blood flow, glaucoma, SLT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (estimated)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| untreated glaucoma patients | – | Procedure: Selective Laser TrabeculoplastyWe will evaluate the blood flow before and after Selective Laser Trabeculoplasty in patients with primary open angel glaucoma. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with untreated primary open angle glaucoma
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Laser TrabeculoplastyPatient will have selective laser trabeculoplasty as the first treatment for glaucoma. This treatment will be dictated clinically, since we do not assign the interventions. | Procedure or surgery | untreated glaucoma patients |
Primary outcome
blood flow
Time frame: before and two-week after SLT
The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow.
1 secondary outcome
Intraocuclar pressure
Time frame: before and two-week after SLT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Background: PubMed 19907031Venkataraman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Hudson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tien Wong (416-603-5694, twong@uhnres.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood flow (time frame: before and two-week after SLT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01209975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.