Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Not Applicable

• Conditions: Full Thickness Macular Hole
• Interventions: Procedure: inverted flap; Procedure: peeling internal limiting membrane (ILM)

• Registration Number: NCT04498624
• Lead Sponsor: University of Turin, Italy

Brief Summary

Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-07-22
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-03
• Last Update Submitted: 2020-08-03
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-04
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• >18 years old
• idiopathic full thickness macular hole ≤ 350 micron of diameter
• phakic or pseudophakic
• absence of systemic adverse conditions

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Exclusion Criteria

• concomitant retinal and other ocular disease
• previous ocular surgery except cataract surgery
• axial length >26mm

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inverted flap	inverted flap	-
peeling internal limiting membrane (ILM)	peeling internal limiting membrane (ILM)	-

Primary Outcome Measures

Name	Time	Method
Microperimetry retinal sensitivity	3 months	Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA)	3 months	Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
Closure rate	3 months	Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

Trial Locations

Locations (1)

A.O.U. Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy