NCT05897671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 1, 2023

Last Update Submit

June 10, 2023

Conditions

Full Thickness Macular Hole

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • visual acuity

    3 months

  • OCT

    3 months

Study Arms (1)

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

Interventions

retrospective data analysisOTHER

Macular hole closure rate, visual acuity and OCT

study group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

Location

Study Officials

  • Oliver Findl, Prof.

    head of departement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 9, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)