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Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00824824
First received: January 16, 2009
Last updated: March 31, 2017
Last verified: March 2017
January 16, 2009
March 31, 2017
January 2009
August 2012   (Final data collection date for primary outcome measure)
Presence of Retinal Vascular Dysregulation (RVD) [ Time Frame: 6 weeks post treatment ]
We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.
Change in retinal blood flow with increase in perfusion pressure due to posture change [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00824824 on ClinicalTrials.gov Archive Site
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Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Glaucoma
  • Drug: Dorzolamide 2%-timolol 0.5%
    BID OU for 6 weeks
    Other Names:
    • Cosopt
    • RVD intervention after run-in on timolol 0.5% bid OU
  • Drug: Brimonidine 0.2%-0.5% timolol 0.5
    BID OU for 6 weeks
    Other Names:
    • Combigan
    • RVD intervention after run-in on timolol 0.5% bid OU
  • Experimental: Brimonidine 0.2%-timolol 0.5% arm
    Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.
    Intervention: Drug: Brimonidine 0.2%-0.5% timolol 0.5
  • Active Comparator: Dorzolamide 2%-timolol 0.5% arm
    Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks
    Intervention: Drug: Dorzolamide 2%-timolol 0.5%
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • POAG
  • Age 40 to 80 years
  • Untreated IOP greater than 21 mm Hg

Exclusion Criteria:

  • More than two IOP lowering medications
  • Exfoliation or pigment dispersion syndrome
  • Diabetic retinopathy
  • History of ocular surgery
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00824824
08-12-057
No
Not Provided
No
Not Provided
Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Principal Investigator: Louis Pasquale Mass Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP