Study of Retinal Sensitivity by Microperimetry During Epi... | NCT02084212

Studies
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

NCT02084212

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Terminated

Last Update Posted

Sep 4, 2019Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Epiretinal Membrane Surgery

Interventions

Microperimetry

Countries

France

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2013Actual

Primary Completion Date

Apr 24, 2015Actual

Completion Date

Apr 24, 2015Actual

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 11, 2014Estimated

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

Sep 3, 2019

Last Update Posted Date

Sep 4, 2019Actual

Description Module

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.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients about to undergo epiretinal membrane surgery	Other		Other: Microperimetry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microperimetry	Other		Patients about to undergo epiretinal membrane surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Abnormal surface autofluorescence		Up to 6 months after the operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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