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Clinical Trials/NCT02084212
NCT02084212TerminatedNot Applicable

Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Centre Hospitalier Universitaire Dijon2 sites in 1 country6 target enrollmentStarted: March 6, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
6
Locations
2
Primary Endpoint
Evaluation of retinal sensitivity by microperimetry

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients about to undergo epiretinal membrane surgery

Other

Intervention: Microperimetry (Other)

Outcomes

Primary Outcomes

Evaluation of retinal sensitivity by microperimetry

Time Frame: Up to 6 months after the operation

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

Time Frame: Up to 6 months after the operation.

Anomalies observed in the outer layers of retina

Time Frame: Up to 6 months after the operation

Secondary Outcomes

  • Abnormal surface autofluorescence(Up to 6 months after the operation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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