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

Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04498624

Enrollment

Registered

2020-08-04

Start date

2020-05-01

Completion date

2021-05-01

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full Thickness Macular Hole

Keywords

Full thickness macular hole, Vitrectomy, Inverted flap, Internal limiting membrane peeling

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

Interventions

PROCEDUREinverted flap

full thickness macular hole surgery

PROCEDUREpeeling internal limiting membrane (ILM)

full thickness macular hole surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactMIchele Reibaldi, MD

michele.reibaldi@unito.it0116331863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026