A study to evaluate the effect of cyclosporine 2% eye drop on surgical result of glaucoma surgery (trabeculectomy)
Phase 2
- Conditions
- glaucoma.Primary Open-Angle Glaucoma
- Registration Number
- IRCT138706111154N1
- Lead Sponsor
- Vice Chancellor for Research, Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Inclusion Criteria: POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation.
Exclusion Criteria
Age <20 years; History of previous ocular surgery in the same eye; Candidate for combined surgery; Pregnancy; Breast feeding; Monocular subject; Allergy to any topical antiglaucoma medication, or cyclosporine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraocular pressure (IOP). Timepoint: monthly. Method of measurement: Goldmann applanation tonometer (GAT).;Bleb morphology. Timepoint: monthly. Method of measurement: clinical observation and slit photography (IBAGS).;Subjective dry eye symptoms. Timepoint: monthly. Method of measurement: questionnaire.
- Secondary Outcome Measures
Name Time Method Success rate. Timepoint: Mid-term success rate (6 month following surgery) would be evaluated. Method of measurement: clinical exam.;Complication rate. Timepoint: Midterm complication rate (6 month following surgery) would be evaluated. Method of measurement: clinical exam.;Visual acuity. Timepoint: monthly. Method of measurement: clinical exam (logMAR).