CompletedNot Applicable

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

India44 participantsStarted 2018-07-13

Plain-language 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.

Who can participate

Age range1 Month – 3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 1 month to 3 years (inclusive) * Any case diagnosed as congenital glaucoma (with enlarged corneal diameter more than 11 mm, including corneal edema or Haab'sstria with or without optic disc cupping, IOP\>12 mm Hg) * Parents of the patientis willing and able to comply with study procedures and sign informed consent Exclusion Criteria: * Patients withany other types of secondary glaucoma * Patients with any other ocular disease

What they're measuring

Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time

Timeframe: 12 months

Trial details

NCT IDNCT03541551

SponsorL.V. Prasad Eye Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-01

View on ClinicalTrials.gov More Primary Congenital Glaucoma trials