Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Epiretinal Membrane Surgery Clinical Trial

Official title:

Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02084212
• Other study ID #: ISAICO-MUSELIER AOI 2011
• Status: Terminated
• Phase: N/A
• Start date: March 6, 2013
• Est. completion date: April 24, 2015

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 24, 2015
• Est. primary completion date: April 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epiretinal Membrane
• Epiretinal Membrane Surgery

Intervention

Other:
• Microperimetry

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale		Up to 6 months after the operation.
Primary	Anomalies observed in the outer layers of retina		Up to 6 months after the operation
Primary	Evaluation of retinal sensitivity by microperimetry		Up to 6 months after the operation
Secondary	Abnormal surface autofluorescence		Up to 6 months after the operation