NCT03646695

Brief Summary

Patients with macular hole \<400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 23, 2018

Last Update Submit

August 21, 2021

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (1)

  • closure of the macular hole

    closure of the macular hole will be assessed

    3 months

Study Arms (2)

ILM flap

EXPERIMENTAL

vitrectomy with ILM flap transposition and gas-tamponade will be performed

Procedure: ILM flap transposition

ILM peeling

ACTIVE COMPARATOR

vitrectomy with ILM peeling and gas-tamponade will be performed

Procedure: ILM peeling

Interventions

ILM flap transpositionPROCEDURE

during ILM flap Transposition, an ILM flap is placed on the macular hole

ILM flap
ILM peelingPROCEDURE

during ILM Peeling the ILM is removed around the macular hole

ILM peeling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • macular hole with a diameter \<400µm

You may not qualify if:

  • Prior ILM peeling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Oliver Findl, Professor

    Head of Department of Ophthalmology, Professor, Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Ophthalmology, Professor, Principal Investigator, MBA

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

September 1, 2018

Primary Completion

January 1, 2021

Study Completion

May 1, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

AU(1)