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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Congenital Glaucoma; Developmental Glaucoma; Infantile Glaucoma
• Intervention / Treatment: Procedure: CTT with ologen® Collagen Matrix; Procedure: Trab Trab

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Charitha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CTT with ologen® Collagen Matrix; Experimental: Trabeculotomy with trabeculectomy with ologen implant	Procedure: 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.; Other Names: Ologen with combined trabeculotomy and trabeculectomy
ACTIVE_COMPARATOR: Trab Trab; Active Comparator: Trabeculotomy with trabeculectomy	Procedure: Trab Trab; combined trabeculotomy with trabeculectomy; Other Names: combined trabeculotomy with trabeculectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: L.V. Prasad Eye Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2018
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 1, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (ACTUAL): May 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Hydrophthalmos
• Other Study ID Numbers: IIS-90516

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No