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

Study Overview
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Brief Summary
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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.

Detailed Description
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Standard combined trabeculectomy with trabeculotomy (CTT) All CTT surgeries will be performed under general anesthesia.Under aseptic surgical technique, a superior rectus suture will be placed using 4'0 silk and a limbal-based conjunctival flap to be performed. Sub-Tenon dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular scleralflap will to be dissected up to clear cornea, and radial incision will be placed at the location of the schemes canal, Harms trabepculotome will be used to pass into the schemes canal and rotated into the anterior chamber to open app 60 degree on either sides, A 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl continuous suture. The same procedure will be done for the CTT with ologen® except, before closing the conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex of the triangular scleral flap ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.

Official Title
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Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy

Conditions
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Primary Congenital Glaucoma, Developmental Glaucoma, Infantile Glaucoma

Intervention / Treatment
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* Procedure: CTT with ologen® Collagen Matrix
* Procedure: Trab Trab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Product:ologen® Collagen Matrix, Model: 830601, Shape:Round cylindrical, Size:6mm (diameter) x 2mm (thickness, Manufacturer: Aeon Astron Europe B. V.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTT with ologen® Collagen Matrix<br>Experimental: Trabeculotomy with trabeculectomy with ologen implant | Procedure: CTT with ologen® Collagen Matrix<br>* 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.<br>* Other names: Ologen with combined trabeculotomy and trabeculectomy;|
| Active Comparator: Trab Trab<br>Active Comparator: Trabeculotomy with trabeculectomy | Procedure: Trab Trab<br>* combined trabeculotomy with trabeculectomy<br>* Other names: combined trabeculotomy with trabeculectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time | Assess control of IOP over time. Complete success is defined as IOP reduction of >20% and / or an IOP constantly <21 mmHg without any antiglaucoma medication. Qualified success is defined as IOP < 21 mmHg with topical antiglaucoma medication. Failure is defined as IOP > 21mmHg in 2 subsequent follow visits despite topical antiglaucoma medication. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing bleb morphology in two groups by change of Moorfields Bleb Grading System (MBGS) score over time | Assess bleb characteristics using Moorfields Bleb Grading System (MBGS) score as measurement tool to document bleb grading score over time, clinically and with photographs | 12 months |