FindTrial
Sign In

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

Comparative evaluation of trabeculectomy with Mitomycin C vs. trabeculectomy with Mitomycin C augmented with biodegradable collagen implant (Ologen)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007595
Enrollment
50
Registered
2016-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with primary adult glaucoma

Interventions

Intervention1: Trabeculectomy with Ologen collagen matrix with Mitomycin C: Trabeculectomy will be performed with subconjunctival application of Mitomycin C (0.1 mg/ml) for 1 minute. In addition, Olog

Sponsors

All India Institute Of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Intraocular pressureTimepoint: Post operative day 1, day 7, 1 month, 3 months, 6 months—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactMrittika Sen

All India Institute Of Medical Sciences

tanujdada@gmail.com9873336315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026