Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- success rate (complete and qualified success)
Study Overview
Brief Summary
Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed primary or secondary open-angle glaucoma
- •IOP > 16 mmHg (<60 days prior surgery)
- •IOP > 21 mmHg
- •no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
Exclusion Criteria
- •angle closure glaucoma
- •congenital glaucoma
- •combined procedures (glaucoma and cataract)
Outcomes
Primary Outcomes
success rate (complete and qualified success)
Time Frame: 2 years
Success is defined 1. IOP \< 21 mmHg and at least 20% IOP reduction from baseline 2. IOP \< 18 mmHg
Secondary Outcomes
- IOP, medication, complications(2 years)