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

Study Overview
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Brief Summary
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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. 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. 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
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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

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

Conditions
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Glaucoma, Cataract, Wound Heal

Intervention / Treatment
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* Device: Ologen
* Procedure: Phacotrabeculectomy
* Drug: Mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |