Cataract, Glaucoma, Wound Heal
Conditions
Brief 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.
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
Interventions
DEVICEOlogen
Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
PROCEDUREPhacotrabeculectomy
Trabeculectomy with cataract extraction
DRUGMitomycin C
Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
Sponsors
Aeon Astron Europe B.V.
Medical University of Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean intraocular pressure (IOP) after the surgery | 12 months | Decrease in IOP before and after the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean best corrected visual acuity (BCVA) (LogMAR) | 12 months | Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery |
| Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System) | 12 months | To compare filtrating blebs in two arms of the study |
| Mean number of antiglaucoma medications | 12 months | To compare the number of antiglaucoma medications in two arms of the study |
Outcome results
None listed