Foveal Sparing ILM Peeling With ILM Flap Transposition

Completed

• Conditions: Full Thickness Macular Hole
• Interventions: Other: retrospective data analysis

• Registration Number: NCT05897671
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief Summary

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.

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 Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-09
• Last Update Submitted: 2023-06-10
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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Exclusion Criteria

• Age <18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	retrospective data analysis	retrospective data analysis of patients that underwent after foveal sparing ILM peeling with ILM flap transposition for macular hole repair

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hanusch Hospital, Department of Ophthalmology; 🇦🇹 Vienna, Austria