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

NCT04135638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-10-22

No results posted yet for this study

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.

Conditions

  • Macular Holes

Interventions

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

Sponsors & Collaborators

  • Ospedale Policlinico San Martino

    collaborator OTHER

  • Fondazione G.B. Bietti, IRCCS

    collaborator OTHER

  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara

    collaborator OTHER

  • University of Molise

    lead OTHER

Principal Investigators

  • Ciro Costagliola · University of Molise

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-03-31
Completion
2020-04-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135638 on ClinicalTrials.gov