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Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma

NCT03548805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-12

No results posted yet for this study

Summary

To the best of Investigator knowledge, no studies to this date have compared the safety and efficacyof ologen® Collagen Matrix to MMC in exaggerated healing response among JOAG patients. Given that,filtration surgery is usually less successful in patients with juvenile glaucoma; the purpose of this study is to compare these two adjuvant therapies in exaggerated healing response among JOAG patients. Investigator hypothesis is that trabeculectomy with ologen® Collagen Matrix would be as effective as MMC in IOP control, with prominent bleb morphology as compared to MMC bleb.

Conditions

Interventions

PROCEDURE

ologen® Collagen Matrix

Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs

PROCEDURE

Trabeculectomy with low dose mitomycin C

Trabeculectomy with low dose MMC

Sponsors & Collaborators

  • L.V. Prasad Eye Institute

    lead OTHER

Principal Investigators

  • Senthil Sirisha, MS · YES

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2023-04-01
Completion
2023-05-19

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548805 on ClinicalTrials.gov