Fundus Autofluorescence After Vitrectomy for Epiretinal M... | NCT02628158

Studies
Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane

NCT02628158

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Dec 11, 2015Estimated

Enrollment

91Actual

Phase

Not provided

Conditions

Epiretinal Membrane

Interventions

Vitrectomy with internal limiting membrane removal

Countries

Japan

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

Dec 2015

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

Apr 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 6, 2015

First Submission Date that Met QC Criteria

Dec 8, 2015

First Posted Date

Dec 11, 2015Estimated

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

Dec 8, 2015

Last Update Posted Date

Dec 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators evaluate whether presence of FAF may correlate to the postoperative visual outcome for epiretinal membrane.

Detailed Description

92 eyes with epiretinal membrane were performed vitreous surgery, epiretinal membrane removal and internal limiting membrane (ILM) peeling. Presence of hyperfluorescence in FAF at the macular area and best-corrected visual acuity (BCVA) was evaluated preoperatively and at postoperative 1, 3, and 6 months with ultra-wide angle imaging.

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

91Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy with internal limiting membrane removal	Procedure	Vitrectomy with removal of epiretinal membrane and internal limiting membrane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity before and after surgery	Vision	Changes from baseline to 1, 3, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Presence of fluids autofluorescence at the macular area	Fundus autofluorescence	Changes from baseline up to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal for epiretinal membrane and had followed for more than 6 months.

Exclusion Criteria:

The patients with follow-up less than 6 months.

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

The patients with epiretinal membrane who underwent vitrectomy with epiretinal membrane and internal limiting membrane removal

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Makoto Inoue, MD	Kyorin Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyorin Eye Center		Mitaka	Tokyo	181-8611	Japan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided