Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculec… (NCT03766425) | Clinical Trial Compass
CompletedEarly Phase 1
Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.
Poland64 participantsStarted 2017-06-14
Plain-language summary
Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Primary open-angle glaucoma or capsular glaucoma.
✓. Patient's age: over 40 years, no sex preference;
✓. Local treatment ineffective due to:
✓. Intraocular pressure above 21mmHg at maximum pharmacological therapy (using β-blocker + carbonic anhydrase inhibitor + prostaglandins) or
✓. Intolerance to topical treatment or
✓. Progression in visual field examination
✓. Lack of previous ophthalmological surgical interventions.
✓. Lack of previously performed laser gonioplasty.
Exclusion criteria
✕. Patient with primary closed-angle glaucoma or secondary glaucoma (except for glaucoma in the course of pseudoexfoliation syndrome).
✕. One-eye patient.
✕. Patient with aphakia.
✕. Patient after previous ophthalmic procedures (cataract removal by phacoemulsification with an implant of an intraocular lens, vitrectomy by pars plana, keratoplasty).
✕. A patient diagnosed or suspected of having uveitis or intraocular inflammation.
✕
What they're measuring
1
Effectiveness of aflibercept and mitomycin on the morphology of the bleb;
Timeframe: 1 year
2
Effectiveness of aflibercept and mitomycin on the function of the bleb;
. Any corneal abnormalities or other conditions that prevent reliable testing with an applanation device in the treated eye, including earlier refractive surgery of the eye.