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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Drug: Dorzolamide 2%-timolol 0.5%; Drug: Brimonidine 0.2%-0.5% timolol 0.5

• Registration Number: NCT00824824
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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 available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2012-08-30
• Results First Submitted QC: 2016-10-27
• Results First Posted: 2016-10-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dorzolamide 2%-timolol 0.5% arm	Dorzolamide 2%-timolol 0.5%	Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks
Brimonidine 0.2%-timolol 0.5% arm	Brimonidine 0.2%-0.5% timolol 0.5	Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.

Primary Outcome Measures

Name	Time	Method
Presence of Retinal Vascular Dysregulation (RVD)	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.

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States