NCT03506542

Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy. 2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. 3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

Detailed description

* Prospective randomized comparative study * Patients with cataract and: primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG) * Phacotrabeculectomy augmented with OLO or MMC * Follow-up - 12 months

Conditions

• Glaucoma
• Cataract
• Wound Heal

Interventions

Type	Name	Description
DEVICE	Ologen	Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
PROCEDURE	Phacotrabeculectomy	Trabeculectomy with cataract extraction
DRUG	Mitomycin C	Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)

Timeline

• Start date: 2014-06-02
• Primary completion: 2016-03-01
• Completion: 2017-03-30
• First posted: 2018-04-24
• Last updated: 2018-04-25

Regulatory

• FDA-regulated device study