Clinical Trial: Combined Trab+Trab Versus Combined Trab+Trab With Subconjunctival Implantation of Ologen for Primary Congenital Glaucoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary "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.
Sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Postoperative complications and appearances. [ Time Frame: At postoperative up to 24 months. ]
Inspections of hyphema, severe anterior chamber reaction, hypotony, supracholoidal hemorrhage, flat anterior chamber, endophthalmitis, choroidal detachment, wound or bleb leak.
Visual acuity (if possible), bleb appearance, and anterior chamber inflammation.
Original Secondary Outcome: Same as current
Information By: National Centre of Ophthalmology named after academician Zarifa Aliyeva
Dates:
Date Received: April 19, 2014
Date Started: September 2010
Date Completion: September 2015
Last Updated: July 18, 2015
Last Verified: July 2015
