Status:
ENROLLING_BY_INVITATION
Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Lead Sponsor:
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborating Sponsors:
Ukrainian Vitreoretinal Society
Conditions:
Idiopathic Macular Hole
Macular Hole
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using perfluoropropane (15% C3F8), sulfur hexafluor...
Detailed Description
The project is a randomized clinical trial with a follow up time of 6 months comparing the effects of surgical treatment of large (410-1000 μm) idiopathic macular holes. Patients are randomized to vit...
Eligibility Criteria
Inclusion
- Patient age 50 or above.
- Duration of Symptoms ≤ 12 months.
- Macular holes having a diameter 410-1000 μm.
- Informed consent.
Exclusion
- Patients under 50 years of age.
- A patient who has already undergone treatment (surgery, laser etc.) for any disease of the retina.
- Traumatic or pediatric macular holes, and associated retinal detachment.
- History of any retinal disease such as high myopia, retinal dystrophies, central serous retinopathy, retinal vascular diseases, diabetic retinopathy, uveitis etc.
- Previous history of glaucoma or ocular hypertension.
- Failure to give informed consent.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06927544
Start Date
February 1 2025
End Date
February 1 2027
Last Update
April 17 2025
Active Locations (1)
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1
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine, 65061