NCT03465865

Brief Summary

ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

7.3 years

First QC Date

March 8, 2018

Last Update Submit

February 11, 2025

Conditions

Macular Hole

Outcome Measures

Primary Outcomes (1)

  • OCT

    macular hole closure is assessed with optical coherence tomography

    5 minutes

Secondary Outcomes (1)

  • visual acuity

    5 minutes

Study Arms (1)

ILM-flap

Patients after surgical repair of macular holes with ILM-flap transposition are invitied to a follow-up for optical coherence tomography and visual acuity testing one year after surgery

Device: optical coherence tomography

Interventions

optical coherence tomographyDEVICE

optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.

Also known as: visual acuity test
ILM-flap

Eligibility Criteria

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

Patients are invited for a follow-up one year after ILM-flap transposition for surgical repair of macular holes

You may qualify if:

  • history of ILM-flap transposition

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Oliver Findl, Prof

    VIROS at Hanuschkrankenhaus Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the department of ophthalmology, professor, MBA

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 14, 2018

Study Start

September 1, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)