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

NCT03541551 | Completed

• 1 other identifier: IIS-90516
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Congenital Glaucoma; Developmental Glaucoma; Infantile Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparing bleb morphology in two groups by change of Moorfields Bleb Grading System (MBGS) score over time

  12 months

Study Arms (2)

CTT with ologen® Collagen Matrix

EXPERIMENTAL

Experimental: Trabeculotomy with trabeculectomy with ologen implant

Procedure: CTT with ologen® Collagen Matrix

Trab Trab

ACTIVE COMPARATOR

Active Comparator: Trabeculotomy with trabeculectomy

Procedure: Trab Trab

Interventions

CTT with ologen® Collagen Matrix 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.

Also known as: Ologen with combined trabeculotomy and trabeculectomy

CTT with ologen® Collagen Matrix

Trab Trab PROCEDURE

combined trabeculotomy with trabeculectomy

Also known as: combined trabeculotomy with trabeculectomy

Trab Trab

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients withany other types of secondary glaucoma
• Patients with any other ocular disease

Sponsors & Collaborators

• L.V. Prasad Eye Institute: lead

Study Sites (1)

Charitha

Hyderabad, Telangana, 500034, India

Location

MeSH Terms

Conditions

Hydrophthalmos

Interventions

collagen-glycosaminoglycan copolymer; Trabeculectomy

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• senthil sirisha, MS

  YES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant-Ophthalmologist

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

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: May 30, 2018
• Study Start: July 13, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

IN (1)