Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Postoperative Intraocular Pressure Change
Study Overview
Brief Summary
To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.
Detailed Description
To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Open angle glaucoma
- •Maxima anti-glaucoma medication failed
- •Able to complete the follow up
Exclusion Criteria
- •Topical eye inflammation
- •Angle closure glaucoma
- •Deformity glaucoma
- •One eye glaucoma
- •Previous conjunctiva opened
- •Allergy to collagen
Arms & Interventions
MITOMYCIN-C
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.
Intervention: Mitomycin-C(MMC) and glaucoma filtering surgery (Drug)
ologen (Oculusgen)
20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Intervention: Collagen Matrix in Glaucoma Filtering Surgery (Device)
Outcomes
Primary Outcomes
Postoperative Intraocular Pressure Change
Time Frame: 30 days
Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Secondary Outcomes
- Complications(360 days)