Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2013-08-31
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ologen implantation (single arm)
Ologen implantation as an adjunctive to trabeculectomy
Ologen
Interventions
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Ologen
Eligibility Criteria
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Inclusion Criteria
* Indication for trabeculectomy with mitomycin-C
Exclusion Criteria
* Difficulty in reading or speaking Dutch
* Previous ocular surgery (cataract surgery allowed)
* Pregnant and breastfeeding women
18 Years
ALL
No
Sponsors
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Aeon Astron Europe B.V.
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Henny Beckers
MD, PhD, Ophthalmologist
Locations
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University Eye Clinic
Maastricht, , Netherlands
Countries
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Other Identifiers
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NL42312.068.12/METC12-2-073
Identifier Type: -
Identifier Source: org_study_id
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