Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 16, 2009 |
| Last Updated Date | April 19, 2012 |
| Start Date ICMJE | January 2009 |
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Change in retinal blood flow with increase in perfusion pressure due to posture change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00824824 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG) |
| Official Title ICMJE | Not Provided |
| Brief Summary | We have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (POAG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this often does not occur. As a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma. The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as IOP-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
| Condition ICMJE | Glaucoma |
| Intervention ICMJE |
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| Study Arm (s) | Not Provided |
| Publications * | Feke GT, Pasquale LR. Retinal blood flow response to posture change in glaucoma patients compared with healthy subjects. Ophthalmology. 2008 Feb;115(2):246-52. Epub 2007 Aug 8. |
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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 | 40 |
| Estimated Completion Date | April 2012 |
| Estimated Primary Completion Date | April 2012 (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 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00824824 |
| Other Study ID Numbers ICMJE | 08-12-057 |
| Has Data Monitoring Committee | No |
| Responsible Party | Massachusetts Eye and Ear Infirmary |
| Study Sponsor ICMJE | Massachusetts Eye and Ear Infirmary |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Massachusetts Eye and Ear Infirmary |
| Verification Date | April 2012 |
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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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