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

Primary Congenital Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541551
• Other study ID #: IIS-90516
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: April 2022
• Source: L.V. Prasad Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Glaucoma
• Glaucoma
• Infantile Glaucoma
• Primary Congenital Glaucoma

Intervention

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.
• Trab Trab
combined trabeculotomy with trabeculectomy

Locations

Country	Name	City	State
India	Charitha	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
L.V. Prasad Eye Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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