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Intervention Group for Glaucoma
Phase 4
Waitlist Available
Led By Devesh K Varma, MD FRCSC
Research Sponsored by Credit Valley EyeCare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights
Study Summary
After implantation of an Ahmed glaucoma valve in patients with glaucoma, hyperencapsulation phase is an unwanted postoperative phenomenon, typically occurring with the free 3 months postoperatively. When this does occur, it is treated with aqueous suppressant eye drops. This study aims to determine if it is possible to reduce the rate of hyperencapsulation phase. Patients in the treatment group will receive aqueous suppressant eye drops before the hyperencapsulation phase starts. Treatment will be initiated once their intraocular pressure is above a pre-defined level, and will target a pre-defined range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intraocular pressure
Secondary outcome measures
Absolute Ahmed Glaucoma Valve success
Hyperencapsulation phase (HEP)
Number of glaucoma medications
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Patients randomized to the intervention group will receive aqueous suppressant eyedrops in a stepwise fashion in order to maintain their intraocular pressure between 7-10mmHg.
Group II: Control GroupActive Control1 Intervention
Patients randomized to the control group will receive standard of care treatment. They will not be aqueous suppressed within the first three postoperative months unless the bleb hyperencapsulates.
(If they experience the hyperencapsulation phase, they will continue to receive standard of care treatment, which would then be aqueous suppressant eye drops added in a stepwise fashion)
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Who is running the clinical trial?
Credit Valley EyeCareLead Sponsor
3 Previous Clinical Trials
478 Total Patients Enrolled
3 Trials studying Glaucoma
478 Patients Enrolled for Glaucoma
Canadian Glaucoma Clinical Research CouncilOTHER
2 Previous Clinical Trials
92 Total Patients Enrolled
2 Trials studying Glaucoma
92 Patients Enrolled for Glaucoma
Devesh K Varma, MD FRCSCPrincipal InvestigatorUniversity of Toronto
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