An interventional study of Ologen in Glaucoma, sponsored by Maastricht University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-25.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 7 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ologen implantation as an adjunctive to trabeculectomy
Device: Ologen
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number of patients withdrawn from study because of failure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
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center