Status:
UNKNOWN
Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
Lead Sponsor:
University of Molise
Collaborating Sponsors:
Ospedale Policlinico San Martino
Fondazione G.B. Bietti, IRCCS
Conditions:
Macular Holes
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of ...
Detailed Description
Patients will be randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. "Cover" when the ILM flap is everted over the MH gap in a single layer, "Fill" when the ILM is f...
Eligibility Criteria
Inclusion
- patients with idiopatic macular holes
Exclusion
- Patients with MH duration greater than 6 months
- myopia exceeding 6 diopters
- history of trauma
- previous ocular surgery except uncomplicated cataract extraction with in-the-bag IOL implantation
- any ocular illness including glaucoma, uveitis, optic nerve pathology
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04135638
Start Date
November 1 2019
End Date
April 10 2020
Last Update
October 22 2019
Active Locations (1)
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1
University of Molise
Campobasso, Italy