Glaucoma
Conditions
Keywords
Intraocular pressure, glaucoma, trabeculectomy, Ologen
Brief summary
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.
Interventions
DEVICEOlogen
Sponsors
Aeon Astron Europe B.V.
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication. * Indication for trabeculectomy with mitomycin-C
Exclusion criteria
* Unability to discontinue oral anticoagulants * Difficulty in reading or speaking Dutch * Previous ocular surgery (cataract surgery allowed) * Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative intraocular pressure level | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of glaucoma medications | 3 months |
Other
| Measure | Time frame |
|---|---|
| bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3) | 3 months |
| surgery time | 3 months |
| complexity of surgical procedure | 3 months |
| number of patients withdrawn from study because of failure | 3 months |
Countries
Netherlands
Outcome results
None listed