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Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison

Macular Holes Clinical Trial

Official title:
Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery

Clinical Trial 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 the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.

Clinical Trial 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 folded into multiple layers within the MH. All patients will undergo BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery.

Purpose of the study is to report retinal differential sensitivity and fixation stability as well as anatomic and visual outcomes of patients operated on for idiopathic MH and randomly assigned to Fill or Cover Groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04135638
Study type Interventional
Source University of Molise
Contact Ciro Costagliola, MD
Phone +390874404448
Email ciro.costagliola@unimol.it
Status Recruiting
Phase N/A
Start date November 1, 2019
Completion date April 10, 2020
View Details
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