Foveal Sparing ILM Peeling With ILM Flap Transposition

Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques.

Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

Study Overview

• Status: Completed
• Conditions: Full Thickness Macular Hole
• Intervention / Treatment: Other: retrospective data analysis

Detailed Description

Idiopathic full thickness macular holes lead to central defects in the visual field and to deterioration of the visual acuity. Introduction of internal limiting membrane (ILM) Peeling techniques lead to significant increase in closure rates of the macular holes.

Foveal sparing ILM peeling represents a surgical technique for macular hole repair with less surgical trauma with high closure rates of the macular hole, compared to classic ILM Peeling [Ho et al. 2014, Murphy et al 2019]. The combination of foveal sparing ILM Peeling with the established ILM flap techniques [Michalewska et al 2010 und 2015] offers the potential of better improvement in postsurgical visual acuity with the high closure rates, due to ILM flaps.

Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Hanusch Hospital, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected by the clinical investigators in the Hanusch Hospital

Description

Inclusion Criteria:

• Vitrectomy with foveal sparing ILM peeling with ILM flap transposition in the time period from 1.10.2020 to 8.7.2022
• Age 18 and older
• Idiopathic full thickness macular hole as indication for surgery
• Full follow-up, including visual acuity testing and OCT preoperative, and 3 months after surgery.

Exclusion Criteria:

• Age <18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; retrospective data analysis of patients that underwent after foveal sparing ILM peeling with ILM flap transposition for macular hole repair	Other: retrospective data analysis; Macular hole closure rate, visual acuity and OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
macular hole closure rate	postsurgical closure of macular holes is examined from routine postsurgical optical coherence tomography (OCT) imaging	up to 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity	visual acuity before and 3 months after surgery is examined	3 months
OCT	measurements of macular hole diameters from presurgical OCTs and restoration of the ellipsoid zone (EZ) 3 months after surgery is analysed	3 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prof., head of departement

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: FSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No