ILM Flap Transposition Versus ILM Peeling for Macular Hol... | NCT03646695

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

NCT03646695

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Completed

Last Update Posted

Aug 24, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Macular Holes

Interventions

ILM flap transposition
ILM peeling

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Aug 23, 2018

First Submission Date that Met QC Criteria

Aug 23, 2018

First Posted Date

Aug 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2021

Last Update Posted Date

Aug 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ILM flap transposition	Procedure	during ILM flap Transposition, an ILM flap is placed on the macular hole	ILM flap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
closure of the macular hole	closure of the macular hole will be assessed	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

macular hole with a diameter <400µm

Exclusion Criteria:

Prior ILM peeling

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Findl, Professor	Head of Department of Ophthalmology, Professor, Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital		Vienna		1140	Austria

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided