NCT02628158

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

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

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

December 6, 2015

Last Update Submit

December 8, 2015

Conditions

Epiretinal Membrane

Keywords

Epiretinal membrane

Outcome Measures

Primary Outcomes (1)

  • Visual acuity before and after surgery

    Vision

    Changes from baseline to 1, 3, 6 months

Secondary Outcomes (1)

  • Presence of fluids autofluorescence at the macular area

    Changes from baseline up to 6 months

Interventions

Vitrectomy with internal limiting membrane removalPROCEDURE

Vitrectomy with removal of epiretinal membrane and internal limiting membrane

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • The patients with follow-up less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 11, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

JP(1)