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NCT03541551

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

Completed NA Last updated 12 April 2022
What this trial tests

NA trial testing CTT with ologen® Collagen Matrix in Primary Congenital Glaucoma in 44 participants. Completed in 1 September 2019.

Timeline
13 July 2018
Primary endpoint
1 September 2019
1 September 2019

Quick facts

Lead sponsorL.V. Prasad Eye Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment44
Start date13 July 2018
Primary completion1 September 2019
Estimated completion1 September 2019
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

L.V. Prasad Eye Institute

Who can join

Adults 1 Month to 3, any sex, with Primary Congenital Glaucoma or Developmental Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Surgical interventions for primary congenital glaucoma.
    Gagrani M, Garg I, Ghate D. · · 2020 · cited 14× · PMID 32816311 · DOI 10.1002/14651858.cd008213.pub3
  2. Device-modified trabeculectomy for glaucoma.
    Park J, Rittiphairoj T, Wang X, E JY, et al · · 2023 · cited 6× · PMID 36912740 · DOI 10.1002/14651858.cd010472.pub3

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Other L.V. Prasad Eye Institute trials

Trials by the same sponsor.

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Data sources for this page

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