NCT04135638

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Molise · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Macular Holes

Interventions

Type	Name	Description
PROCEDURE	Cover Group	"Cover" when the ILM flap is everted over the MH gap in a single layer
PROCEDURE	Fill Group	"Fill" when the ILM is folded into multiple layers within the MH

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-03-31
• Completion: 2020-04-10
• First posted: 2019-10-22
• Last updated: 2019-10-22

Locations

1 site across 1 country: Italy