Foveal Sparing ILM Peeling With ILM Flap Transposition

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Completed
CT.gov ID
NCT05897671
Collaborator
(none)
42
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Foveal Sparing ILM Peeling With ILM Flap Transposition
Actual Study Start Date :
Jun 1, 2023
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. visual acuity [3 months]

    visual acuity before and 3 months after surgery is examined

  2. OCT [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanusch Hospital, Department of Ophthalmology Vienna Austria 1140

Sponsors and Collaborators

  • Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, Prof., head of departement

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Head of department, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT05897671
Other Study ID Numbers:
  • FSI
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2023