Clinical trial to study the effect of using a drug to reduce scarring called Mitomycin C alone compared to a combination of Mitomycin C and a biodegradable implant (Ologen) in surgery for glaucoma
Not Applicable
- Conditions
- Health Condition 1: null- Patients with primary adult glaucoma
- Registration Number
- CTRI/2016/12/007595
- Lead Sponsor
- All India Institute Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Patients with primary adult glaucoma.
2. Age >40 years.
3. Not controlled on maximum topical medical therapy.
4. Patient willing to give informed consent and able to comply with study procedures.
Exclusion Criteria
Details 1. Known allergy to mitomycin c or collagen.
2. One eyed patients.
3. Neovascular, uveitic, aphakic glaucoma and other causes of secondary glaucoma.
4. History of previous glaucoma surgery or slt.
5. Cataract surgery within 12 months.
6. Pregnant or breast feeding women.
7. Age < 40 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraocular pressureTimepoint: Post operative day 1, day 7, 1 month, 3 months, 6 months
- Secondary Outcome Measures
Name Time Method Bleb morphologyTimepoint: Post operative 1 month, 3 months, 6 months;Need for post-operative adjunctive proceduresTimepoint: Post operative day 1, day 7, 1 month, 3 months, 6 months;Need for post-operatve medicationsTimepoint: Post operative day 1, day 7, 1 month, 3 months, 6 months;Post operative complicationsTimepoint: Post operative day 1, day 7, 1 month, 3 months, 6 months