ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

Sponsor

Vienna Institute for Research in Ocular Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT03646695

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Macular Holes	Procedure: ILM flap transposition Procedure: ILM peeling	N/A

Detailed Description

Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter <400µm. Therefore, patients with macular hole with a diameter <400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ILM flap vitrectomy with ILM flap transposition and gas-tamponade will be performed	Procedure: ILM flap transposition during ILM flap Transposition, an ILM flap is placed on the macular hole
Active Comparator: ILM peeling vitrectomy with ILM peeling and gas-tamponade will be performed	Procedure: ILM peeling during ILM Peeling the ILM is removed around the macular hole

Arm

Intervention/Treatment

Experimental: ILM flap

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

Procedure: ILM flap transposition

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

Active Comparator: ILM peeling

vitrectomy with ILM peeling and gas-tamponade will be performed

Procedure: ILM peeling

during ILM Peeling the ILM is removed around the macular hole

Outcome Measures

Primary Outcome Measures

closure of the macular hole [3 months]
closure of the macular hole will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

macular hole with a diameter <400µm

Exclusion Criteria:

Prior ILM peeling

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital	Vienna		Austria	1140

Sponsors and Collaborators

Vienna Institute for Research in Ocular Surgery

Investigators

Principal Investigator: Oliver Findl, Professor, Head of Department of Ophthalmology, Professor, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prim. Prof. Dr. Oliver Findl, MBA, Head of Department of Ophthalmology, Professor, Principal Investigator, MBA, Vienna Institute for Research in Ocular Surgery

ClinicalTrials.gov Identifier:

NCT03646695

Other Study ID Numbers:

ILM flap

First Posted:

Aug 24, 2018

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Perforations

Study Results

No Results Posted as of Aug 24, 2021