Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Congenital Glaucoma
- Sponsor
- National Centre of Ophthalmology named after academician Zarifa Aliyeva
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Intraocular pressure(IOP) reduction
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital glaucoma cases, the efficacy being the primary objective and the safety being the secondary. The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen matrix implant implantation in congenital glaucoma is a safer procedure and may yield better results than combined trabeculotomy-trabeculectomy approach.
Detailed Description
"Ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in filtration surgery, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects. Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 7,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Haab's stria with or without optic disc cupping.
- •Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
- •Within the age of (0 - 12).
Exclusion Criteria
- •Cases of congenital glaucoma with previous intervention. Age above 12 Yrs. Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
Outcomes
Primary Outcomes
Intraocular pressure(IOP) reduction
Time Frame: At postoperative up to 24 months
"Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP. Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size. "Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters. In the specified time frame, patients will also visit for record at day 7, 30, 90, 180 days, 12, 18, and 24 months.
Secondary Outcomes
- Postoperative complications and appearances.(At postoperative up to 24 months.)