NCT02084212

Brief Summary

The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data. The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.

Trial Health

57
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Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2015

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

March 5, 2014

Last Update Submit

September 3, 2019

Conditions

Epiretinal Membrane Surgery

Outcome Measures

Primary Outcomes (3)

  • Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale

    Up to 6 months after the operation.

  • Anomalies observed in the outer layers of retina

    Up to 6 months after the operation

  • Evaluation of retinal sensitivity by microperimetry

    Up to 6 months after the operation

Secondary Outcomes (1)

  • Abnormal surface autofluorescence

    Up to 6 months after the operation

Study Arms (1)

Patients about to undergo epiretinal membrane surgery

OTHER
Other: Microperimetry

Interventions

MicroperimetryOTHER
Patients about to undergo epiretinal membrane surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons who have provided consent,
  • Patients about to undergo idiopathic epiretinal membrane surgery,
  • Patients undergoing first-line macular surgery

You may not qualify if:

  • Persons not covered by national health insurance
  • Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
  • Preoperative amblyopic eye
  • Insufficiently transparent media making it impossible to do the examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 11, 2014

Study Start

March 6, 2013

Primary Completion

April 24, 2015

Study Completion

April 24, 2015

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

FR(1)