To analyze surgical success comparing a single medication (antifibrotic drug) with double medication (same antifibrotic plus antiproliferative drug) in trabeculectomy (filtrating surgery to decrease intraocular pressure in glaucoma patients)
Not Applicable
Completed
- Conditions
- TrabeculectomySurgery
- Registration Number
- ISRCTN93098069
- Lead Sponsor
- Centro Hospitalar Lisboa Norte
- Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33931389/ (added 05/05/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
1. Patients submitted to primary trabeculectomy for open-angle glaucoma between October 2015 and March 2019
2. No other previous surgeries, except uncomplicated phaco
3. = 18 years and have agreed to chart review as per GDPR regulations
Exclusion Criteria
1. Pregnancy or breastfeeding
2. Combination with cataract surgery
3. History of another eye disease
4. Uncontrolled blood pressure (systolic >180 mmHg and/or diastolic >100 mmHg while a patient is at rest)
5. Severe cardiovascular disease (including a stroke or a myocardial infarction 6 months before)
6. Known allergic reaction to bevacizumab or MMC
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The absolute and qualified surgical success rate of trabeculectomy at 12 months and 24 months defined as intraocular pressure =18 mmHg and >5mmHg with at least 30% reduction in IOP from baseline
- Secondary Outcome Measures
Name Time Method <br> 1. Intra- and postoperative complications measured using patient records<br> 2. Additional effects of bevacizumab measured using patient records<br>