Prognostic Factors in Epiretinal Membrane Surgery

Epiretinal Membranes Clinical Trial

Official title:

Preoperative Prognostic Factors and Predictive Score in Patients Operated on for Combined Cataract and Idiopathic Epiretinal Membrane.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406430
• Other study ID #: CREUZOT 2013
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: March 30, 2015
• Start date: April 2009

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.

• All patients signed informed consent for the surgical procedure.

Exclusion Criteria:

• Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length = 26 mm or spherical equivalent = 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epiretinal Membrane
• Epiretinal Membranes

Intervention

Procedure:
• a combined cataract and ERM surgery
All patients underwent a combined cataract and ERM surgery owing to visual impairment or disabling metamorphopsia. A complete ophthalmological examination was performed before and at 1,6, and 12 months after the surgery, including best corrected visual acuity with Snellen charts converted into the logarithm of the minimum angle of resolution, slit-lamp biomicroscopy, indirect fundus, and macular optical coherence tomography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	Best corrected visual acuity 1 year after the surgery, and preoperative factors associated with this visual outcome (age, duration of symptoms, initial best corrected visual acuity, and optical coherence tomography findings)	1 year after the surgery	No
Secondary	To set up a predictive score for a >= 20/20 best corrected visual acuity	To set up a predictive score for a >= 20/20 best corrected visual acuity, 1year after a combined cataract and epiretinal membrane surgery	1 year after the surgery	No