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Completed

NCT Number: NCT05897671

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.

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Key information

Conditions

Full Thickness Macular Hole

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retrospective data analysis

Other

Macular hole closure rate, visual acuity and OCT

Primary outcomes

  1. macular hole closure rate

    Time frame: up to 3 months after surgery

    postsurgical closure of macular holes is examined from routine postsurgical optical coherence tomography (OCT) imaging

Secondary outcomes

  1. visual acuity

    Time frame: 3 months

    visual acuity before and 3 months after surgery is examined

  2. OCT

    Time frame: 3 months

    measurements of macular hole diameters from presurgical OCTs and restoration of the ellipsoid zone (EZ) 3 months after surgery is analysed

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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