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.
* 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
Trabeculectomy with cataract extraction
Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
Mean intraocular pressure (IOP) after the surgery
Decrease in IOP before and after the surgery
Time frame: 12 months
Mean best corrected visual acuity (BCVA) (LogMAR)
Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery
Time frame: 12 months
Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)
To compare filtrating blebs in two arms of the study
Time frame: 12 months
Mean number of antiglaucoma medications
To compare the number of antiglaucoma medications in two arms of the study
Time frame: 12 months
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