Status:
COMPLETED
Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.
Lead Sponsor:
Medical University of Lublin
Conditions:
Eye Diseases
Optic Nerve Damage
Eligibility:
All Genders
40+ years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
Glaucoma is a neurodegenerative disease characterized by progressive dying of retinal ganglion cells, axonal loss and damage to the optic nerve. This leads to a gradual loss of the visual field, and i...
Eligibility Criteria
Inclusion
- 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.
- No laser trabeculoplasty or laser trabeculoplasty performed for more than a year.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
June 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03766425
Start Date
June 14 2017
End Date
July 31 2019
Last Update
October 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Lublin
Lublin, Lublin Voivodeship, Poland, 20-059