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Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy

NCT03541551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-04-12

No results posted yet for this study

Summary

To the best of Investigator knowledge, no studies to this date have compared the safety and efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing trabeculectomy. Given that filtration surgery is usually less successful in patients with developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb morphology.

Conditions

  • Primary Congenital Glaucoma
  • Developmental Glaucoma
  • Infantile Glaucoma

Interventions

PROCEDURE

CTT with ologen® Collagen Matrix

ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.

PROCEDURE

Trab Trab

combined trabeculotomy with trabeculectomy

Sponsors & Collaborators

  • L.V. Prasad Eye Institute

    lead OTHER

Principal Investigators

  • senthil sirisha, MS · YES

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • India

Study Locations

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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 NCT03541551 on ClinicalTrials.gov