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ILM Peeling Versus Inverted Flap Technique for Treatment of Macular Hole: Near Visual Acuity Outcomes

NCT04698226 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-09

No results posted yet for this study

Summary

A prospective randomised study comparing the near visual acuity outcomes using Salzburg Reading Desk in pseudophakic patients with idiopathic full-thickness macular hole treated with pars plana vitrectomy with internal limiting membrane peeling versus inverted flap technique. The aim of the study is confirm or disprove the hypothesis, that the near visual acuity results of pars plana vitrectomy with inverted flap technique for idiopathic macular hole are not inferior to pars plana vitrectomy with complete internal limiting membrane peeling technique. Patients will be followed for 6 months after the operation and near best corrected visual acuity testing on Salzburg reading desk, distance best corrected visual acuity on ETDRS tables and microperimetry will be performed and compared between both groups. Also the macular hole closure rate and complication rate will be compared between both groups.

Conditions

  • Macular Holes

Interventions

PROCEDURE

25-gauge pars plana vitrectomy with complete internal limiting membrane peeling and SF6 tamponade

Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining and sulfur hexafluoride (SF6) tamponade

PROCEDURE

25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade

Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. "Flower petal" type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole.

Sponsors & Collaborators

  • Charles University, Czech Republic

    collaborator OTHER

  • Faculty Hospital Kralovske Vinohrady

    lead OTHER_GOV

Principal Investigators

  • Martin Pencak, M.D. · Faculty Hospital Kralovske Vinohrady

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Czechia

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 NCT04698226 on ClinicalTrials.gov