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

University of Turin

Status: Unknown

Conditions: Full Thickness Macular Hole

Treatments: Procedure: peeling internal limiting membrane (ILM); Procedure: inverted flap

Study type: Interventional

Funder types: Other

Identifiers

NCT04498624

0062156

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

inverted flap

Active Comparator group

Treatment:

Procedure: inverted flap

peeling internal limiting membrane (ILM)

Active Comparator group

Treatment:

Procedure: peeling internal limiting membrane (ILM)