Retinal Vascular Reactivity in Subjects With Newly Diagnosed Glaucoma Before and After Selective Laser Trabeculoplasty
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Toronto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Toronto
Collaborator:
University of Western Ontario, Canada
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01209975
First received: June 29, 2010
Last updated: September 27, 2010
Last verified: September 2010
| Tracking Information | |||||
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| First Received Date ICMJE | June 29, 2010 | ||||
| Last Updated Date | September 27, 2010 | ||||
| Start Date ICMJE | November 2008 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
blood flow [ Time Frame: before and two-week after SLT ] [ Designated as safety issue: Yes ] The Canon Laser Blood Flowmetry will be used to assess the retinal blood flow. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01209975 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Intraocuclar pressure [ Time Frame: before and two-week after SLT ] [ Designated as safety issue: Yes ] Intraocular pressure (IOP) will be measured by Goldmann applanation tonometry. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Retinal Vascular Reactivity in Subjects With Newly Diagnosed Glaucoma Before and After Selective Laser Trabeculoplasty | ||||
| Official Title ICMJE | Retinal Vascular Reactivity in Response to Isoxic Hypercapnia in Subjects With Newly Diagnosed Glaucoma | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patient with untreated primary open angle glaucoma |
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| Condition ICMJE | Glaucoma | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | untreated glaucoma patients
We will evaluate the blood flow before and after Selective Laser Trabeculoplasty in patients with primary open angel glaucoma.
Intervention: Procedure: Selective Laser Trabeculoplasty |
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| 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. Epub 2009 Nov 11. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01209975 | ||||
| Other Study ID Numbers ICMJE | SLT-blood flow study | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Chris Hudson, Department of Ophthalmology and Vision Science | ||||
| Study Sponsor ICMJE | University of Toronto | ||||
| Collaborators ICMJE | University of Western Ontario, Canada | ||||
| Investigators ICMJE |
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| Information Provided By | University of Toronto | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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