Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.

• Status: Unknown status
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lublin
• Treatments: Aflibercept; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

1. Primary open-angle glaucoma or capsular glaucoma.

2. Patient's age: over 40 years, no sex preference;

3. Local treatment ineffective due to:

1. Intraocular pressure above 21mmHg at maximum pharmacological therapy (using β-blocker + carbonic anhydrase inhibitor + prostaglandins) or

2. Intolerance to topical treatment or

3. Progression in visual field examination

4. Lack of previous ophthalmological surgical interventions.

5. Lack of previously performed laser gonioplasty.

6. No laser trabeculoplasty or laser trabeculoplasty performed for more than a year.

Exclusion Criteria:

1. Patient with primary closed-angle glaucoma or secondary glaucoma (except for glaucoma in the course of pseudoexfoliation syndrome).

2. One-eye patient.

3. Patient with aphakia.

4. Patient after previous ophthalmic procedures (cataract removal by phacoemulsification with an implant of an intraocular lens, vitrectomy by pars plana, keratoplasty).

5. A patient diagnosed or suspected of having uveitis or intraocular inflammation.

6. 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.