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

Phase 2

Completed

• Conditions: Glaucoma; Cataract; Wound Heal
• Interventions: Device: Ologen; Procedure: Phacotrabeculectomy; Drug: Mitomycin C

• Registration Number: NCT03506542
• Lead Sponsor: Medical University of Lublin

Brief 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

Study Timeline

• Study Start: 2014-06-02
• Primary Completion: 2016-03-01
• Study Completion: 2017-03-30
• Status Verified: 2018-04
• Study First Submitted: 2018-04-14
• Study First Submitted QC: 2018-04-14
• Last Update Submitted: 2018-04-23
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Cataract
• Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

Exclusion Criteria

• Difficulty in reading or speaking Polish
• Previous ocular surgery
• Pregnant and breastfeeding women
• Angle closure glaucoma
• Secondary glaucoma except pseudoexfoliation glaucoma
• Ocular diseases with excessive scarring
• Allergy to collagen or Mitomycin C

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ologen (OLO)	Ologen	Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
Ologen (OLO)	Phacotrabeculectomy	Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
Mitomycin C (MMC)	Phacotrabeculectomy	Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)
Mitomycin C (MMC)	Mitomycin C	Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)

Primary Outcome Measures

Name	Time	Method
Mean intraocular pressure (IOP) after the surgery	12 months	Decrease in IOP before and after the surgery

Secondary Outcome Measures

Name	Time	Method
Mean best corrected visual acuity (BCVA) (LogMAR)	12 months	Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery
Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)	12 months	To compare filtrating blebs in two arms of the study
Mean number of antiglaucoma medications	12 months	To compare the number of antiglaucoma medications in two arms of the study