Trabeculectomy With Ologen
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Trabeculectomy With Ologen-Pilot|
- Postoperative intraocular pressure level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Number of glaucoma medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- surgery time [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- complexity of surgical procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- number of patients withdrawn from study because of failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Ologen implantation (single arm)
Ologen implantation as an adjunctive to trabeculectomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753492
|Contact: Henny Beckers, MD, PhD||+31 43 387 53 email@example.com|
|Contact: Carroll Webers, MD, PhD||+31 43 387 53 firstname.lastname@example.org|
|University Eye Clinic||Recruiting|
|Maastricht, Netherlands, 6202 AZ|
|Contact: Henny Beckers, MD, PhD +31 43 387 53 42 email@example.com|
|Principal Investigator: Henny Beckers, MD, PhD|
|Principal Investigator: Carroll Webers, MD, PhD|