Foveal Sparing ILM Peeling With ILM Flap Transposition

NCT ID: NCT05897671

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Full Thickness Macular Hole

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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study group

retrospective data analysis of patients that underwent after foveal sparing ILM peeling with ILM flap transposition for macular hole repair

retrospective data analysis

Intervention Type OTHER

Macular hole closure rate, visual acuity and OCT

Interventions

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retrospective data analysis

Macular hole closure rate, visual acuity and OCT

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Prof.

Role: PRINCIPAL_INVESTIGATOR

head of departement

Locations

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Hanusch Hospital, Department of Ophthalmology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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FSI

Identifier Type: -

Identifier Source: org_study_id

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