Fovea ERM After Fovea-sparing ILM Peeling | NCT04445142

Studies
Fovea ERM After Fovea-sparing ILM Peeling

NCT04445142

Sponsor

Changhua Christian Hospital

Status

Completed

Last Update Posted

Jun 24, 2020Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Epiretinal Membrane
Internal Limiting Membrane Wrinkling

Interventions

fovea-sparing internal limiting membrane peeling

Countries

Taiwan

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

Jun 2020

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, 2019Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

May 23, 2020

First Submission Date that Met QC Criteria

Jun 22, 2020

First Posted Date

Jun 24, 2020Actual

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

Jun 22, 2020

Last Update Posted Date

Jun 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

San Ni Chen, Head of department of ophthalmology, Changhua Christian HospitalPrincipal Investigator

Lead Sponsor

Changhua Christian HospitalOTHER

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

To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction

Detailed Description

Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on residual internal limiting membrane (ILM) with severe contraction after previous fovea-sparing internal limiting membrane (ILM) peeling.

Study design: Retrospective case series Methods: We report patients who previously received fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
epiretinal membrane group		Patients developed secondary fovea epiretinal membrane	Procedure: fovea-sparing internal limiting membrane peeling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fovea-sparing internal limiting membrane peeling	Procedure	fovea-sparing internal limiting membrane peeling surgery	epiretinal membrane group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity	Snellen visual acuity change	6 months
Optical coherence tomography finding	fovea change on optical coherence tomography	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery

Exclusion Criteria:

patients who did not receive previous fovea-sparing internal limiting membrane surgery

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
San-Ni Chen, MD	Changhua Christian Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of ophthalmology, Changhua Christian Hospital		Changhua		500	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33936809	Derived	Chen YC, Chen SN. Isolated Central Epiretinal Membrane: A Rare Complication of Fovea-Sparing Internal Limiting Membrane Peeling Technique. J Ophthalmol. 2021 Apr 14;2021:6654604. doi: 10.1155/2021/6654604. eCollection 2021.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases