Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy
- Conditions
- Primary Congenital GlaucomaInfantile GlaucomaDevelopmental Glaucoma
- Interventions
- Procedure: CTT with ologen® Collagen MatrixProcedure: Trab Trab
- Registration Number
- NCT03541551
- Lead Sponsor
- L.V. Prasad Eye Institute
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- Patients withany other types of secondary glaucoma
- Patients with any other ocular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CTT with ologen® Collagen Matrix CTT with ologen® Collagen Matrix Experimental: Trabeculotomy with trabeculectomy with ologen implant Trab Trab Trab Trab Active Comparator: Trabeculotomy with trabeculectomy
- Primary Outcome Measures
Name Time Method Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time 12 months 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.
- Secondary Outcome Measures
Name Time Method Comparing bleb morphology in two groups by change of Moorfields Bleb Grading System (MBGS) score over time 12 months Assess bleb characteristics using Moorfields Bleb Grading System (MBGS) score as measurement tool to document bleb grading score over time, clinically and with photographs
Trial Locations
- Locations (1)
Charitha
🇮🇳Hyderabad, Telangana, India