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OpenTrials
Completed

NCT Number: NCT03506542

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

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.

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Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension Wound Heal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ologen

Device

Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C

Other names: OLO

phacotrabeculectomy

Procedure

Trabeculectomy with cataract extraction

Other names: surgery

mitomycin C

Drug

Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)

Other names: MMC

Primary outcomes

  1. Mean intraocular pressure (IOP) after the surgery

    Time frame: 12 months

    Decrease in IOP before and after the surgery

Secondary outcomes

  1. Mean best corrected visual acuity (BCVA) (LogMAR)

    Time frame: 12 months

    Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery

  2. Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)

    Time frame: 12 months

    To compare filtrating blebs in two arms of the study

  3. Mean number of antiglaucoma medications

    Time frame: 12 months

    To compare the number of antiglaucoma medications in two arms of the study

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • Aeon Astron Europe B.V.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 24, 2018
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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