Prospective randomized clinical trial: Surgical success rates in childhood glaucoma: Conventional probe trabeculotomy versus microcatheter-assisted 360°trabeculotomy
Not Applicable
Recruiting
- Conditions
- H40Glaucoma
- Registration Number
- DRKS00034139
- Lead Sponsor
- niversitätsmedizin Mainz, Augenklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Main inclusion criteria:
- Patients with primary or secondary congenital glaucoma in both eyes
- Age = 12
Exclusion Criteria
Main exclusion criteria:
- Indication other than trabeculotomy, e.g. glaucoma drainage device or cyclodestructive treatment
- previous surgical IOP-lowering interventions (i.e. cataract surgery, vitrectomy etc. are allowed)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete surgical success at 24 months (IOP < 18 mmHg without medication and no revision surgery. No change in surgical technique. With MCAT: successful probing of > 120° is also required for success)
- Secondary Outcome Measures
Name Time Method Incomplete surgical success (IOP < 18 mmHg, with medication and/or revision surgery),<br>absolute and relative difference of: intraocular pressure (IOP), axial length, visual acuity,<br>refraction, corneal diameters, cup-to-disc ratio; presence of Haab striae, number of medication drugs, number of revision surgeries, number of intraoperative and postoperative events