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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506542
• Other study ID #: not required
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2018
• Last updated: April 23, 2018
• Start date: June 2, 2014
• Est. completion date: March 30, 2017

Study information

• Verified date: April 2018
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 30, 2017
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Wound Heal

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lublin	Aeon Astron Europe B.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean intraocular pressure (IOP) after the surgery	Decrease in IOP before and after the surgery	12 months
Secondary	Mean best corrected visual acuity (BCVA) (LogMAR)	Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery	12 months
Secondary	Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)	To compare filtrating blebs in two arms of the study	12 months
Secondary	Mean number of antiglaucoma medications	To compare the number of antiglaucoma medications in two arms of the study	12 months