Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
Overview
- Phase
- Phase 3
- Intervention
- ologen collagen matrix in glaucoma filtering surgery
- Conditions
- Glaucoma
- Sponsor
- Pro Top & Mediking Company Limited
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- the effectiveness via the reduction of IOP
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.
Detailed Description
1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy with mitomycin-C. 3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or over.
- •Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- •Subject able and willing to cooperate with investigation plan.
- •Subject able and willing to complete postoperative follow-up requirements.
- •Subject willing to sign informed consent form.
Exclusion Criteria
- •Known allergic reaction to mitomycin-C or Bovine collagen.
- •Subject is on warfarin and discontinuation is not recommended.
- •Normal tension glaucoma.
- •Participation in an investigational study during the 30 days preceding trabeculectomy.
- •Ocular infection within 14 days prior to trabeculectomy.
- •Pregnant or breast-feeding women.
Arms & Interventions
1
20 patients will be recruited according to the enrollment acceptance criteria.Randomisation is performed using a sealed envelope system, where 40 shuffled envelopes designating the surgery to either trabeculectomy with mitomycin-C (MMC) and trabeculectomy with ologen™ Collagen matrix must be open before surgery. Then, patients are allocated and trabeculectomy is performed.If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Intervention: ologen collagen matrix in glaucoma filtering surgery
2
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be randomised to trabeculectomy with mitomycin -C. Randomisation is performed. Then, trabeculectomy is performed
Intervention: MMC in glaucoma filtering surgery
Outcomes
Primary Outcomes
the effectiveness via the reduction of IOP
Time Frame: 180 day
Secondary Outcomes
- the safety via the incidence of complications and adverse events.(180 day)