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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2019-09-01

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.

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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.

Conditions

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Primary Congenital Glaucoma Developmental Glaucoma Infantile Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Product:ologen® Collagen Matrix, Model: 830601, Shape:Round cylindrical, Size:6mm (diameter) x 2mm (thickness, Manufacturer: Aeon Astron Europe B. V.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Eligible patient after screening will be assigned consecutive randomization numbers in ascending order upon enrollment. The patient will be randomized in 1:1ratio to one of two study groups, namely combined trabeculotomy with trabeculectomy with ologen® Collagen Matrix as adjunctive wound modulator(Group A) or combined trabeculotomy with trabeculectomy alone without any adjunctive (Group B). The assigned randomization number will be recorded in each subject's DCF. The randomization scheme will be generated using random function in excel before patient enrollment in order to avoid investigator's patient selection bias.

Study Groups

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CTT with ologen® Collagen Matrix

Experimental: Trabeculotomy with trabeculectomy with ologen implant

Group Type EXPERIMENTAL

CTT with ologen® Collagen Matrix

Intervention Type PROCEDURE

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.

Trab Trab

Active Comparator: Trabeculotomy with trabeculectomy

Group Type ACTIVE_COMPARATOR

Trab Trab

Intervention Type PROCEDURE

combined trabeculotomy with trabeculectomy

Interventions

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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.

Intervention Type PROCEDURE

Trab Trab

combined trabeculotomy with trabeculectomy

Intervention Type PROCEDURE

Other Intervention Names

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Ologen with combined trabeculotomy and trabeculectomy combined trabeculotomy with trabeculectomy

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