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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03506542
Study type Interventional
Source Medical University of Lublin
Contact
Status Completed
Phase Phase 2
Start date June 2, 2014
Completion date March 30, 2017

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