Trabeculectomy With Ologen
|ClinicalTrials.gov Identifier: NCT01753492|
Recruitment Status : Terminated (The results were disappointing.)
First Posted : December 20, 2012
Last Update Posted : May 25, 2015
Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.
Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.
This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.
The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Device: Ologen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trabeculectomy With Ologen-Pilot|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||March 2015|
Experimental: Ologen implantation (single arm)
Ologen implantation as an adjunctive to trabeculectomy
- Postoperative intraocular pressure level [ Time Frame: 3 months ]
- Number of glaucoma medications [ Time Frame: 3 months ]
- bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3) [ Time Frame: 3 months ]
- surgery time [ Time Frame: 3 months ]
- complexity of surgical procedure [ Time Frame: 3 months ]
- number of patients withdrawn from study because of failure [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753492
|University Eye Clinic|
|Maastricht, Netherlands, 6202 AZ|