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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Cataract; Wound Heal
• Intervention / Treatment: Device: Ologen; Procedure: Phacotrabeculectomy; Drug: Mitomycin C

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ologen (OLO); Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy	Device: Ologen; Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C; Other Names: OLO; Procedure: Phacotrabeculectomy; Trabeculectomy with cataract extraction; Other Names: surgery
Active Comparator: Mitomycin C (MMC); Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)	Procedure: Phacotrabeculectomy; Trabeculectomy with cataract extraction; Other Names: surgery; Drug: Mitomycin C; Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure); Other Names: MMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intraocular pressure (IOP) after the surgery	Decrease in IOP before and after the surgery	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Collaborators: Aeon Astron Europe B.V.
• Investigators: Study Chair: Tomasz Żarnowski, MD PhD Prof, Ophthalmology Clinic, Medical University in Lublin, Poland

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: April 14, 2018
• First Submitted That Met QC Criteria: April 14, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: not required

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No