Eye Diseases Clinical Trial
Official title:
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.
Verified date | October 2023 |
Source | Medical University of Lublin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 ß-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. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Lublin | Lublin | Lubelskie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lublin |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of aflibercept and mitomycin on the morphology of the bleb; | Rating the bleb in The Indiana Bleb Appearance Grading Scale, describing bleb height, extent, vascularity, and leakage with the Seidel test. | 1 year | |
Primary | Effectiveness of aflibercept and mitomycin on the function of the bleb; | Measurement of intraocular pressure (Goldmann applanation tonometer) and taking a photo of a bleb. | 1 year | |
Secondary | Impact of tested substances on visual acuity after surgery | Examination of a visual acuity 1 week after operation as well as 1 month, 3 months, 6 months, 12 months | 1 year | |
Secondary | The influence of aflibercept and mitomycin on corneal endothelial cell density after surgery | Examination of the corneal endothelial cell density before the surgery as well as 6 months and 12 months after surgery | 1 year | |
Secondary | Impact of used substances on visual field parameters | Examination of a visual field in SITA (Swedish Interactive Testing Algorithm) FAST strategy before the surgery and 12 months after surgery | 1 year | |
Secondary | Frequencies and type of possible complications. | observing and recording all complications and side effects in both groups of patients | 1 year |
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