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

NCT03506542 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-04-25

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Aeon Astron Europe B.V.

    collaborator INDUSTRY

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Tomasz Żarnowski, MD PhD Prof · Ophthalmology Clinic, Medical University in Lublin, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-02
Primary Completion
2016-03-01
Completion
2017-03-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03506542 on ClinicalTrials.gov