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

Medical University of Lublin

Status and phase: Completed; Phase 2

Conditions: Cataract; Glaucoma; Wound Heal

Treatments: Device: Ologen; Procedure: Phacotrabeculectomy; Drug: Mitomycin C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03506542

not required

Details and patient eligibility

About

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.

Full 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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

53 participants in 2 patient groups

Ologen (OLO)

Experimental group

Description:

Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy

Treatment:

Procedure: Phacotrabeculectomy

Device: Ologen

Mitomycin C (MMC)

Active Comparator group

Description:

Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)

Treatment:

Drug: Mitomycin C

Procedure: Phacotrabeculectomy