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

L.V. Prasad Eye Institute

Status: Completed

Conditions: Infantile Glaucoma; Primary Congenital Glaucoma; Developmental Glaucoma

Treatments: Procedure: CTT with ologen® Collagen Matrix; Procedure: Trab Trab

Study type: Interventional

Funder types: Other

Identifiers

NCT03541551

IIS-90516

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 1 month to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

CTT with ologen® Collagen Matrix

Experimental group

Description:

Experimental: Trabeculotomy with trabeculectomy with ologen implant

Treatment:

Procedure: CTT with ologen® Collagen Matrix

Trab Trab

Active Comparator group

Description:

Active Comparator: Trabeculotomy with trabeculectomy

Treatment:

Procedure: Trab Trab