Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery

This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.

Study Overview

• Status: Completed
• Conditions: Cataract Senile; Epiretinal Membrane
• Intervention / Treatment: Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatient of all gender, with complain of visual impairment and distortion

Description

Inclusion Criteria:

• age > 55 years
• visual acuity ≤ 20/40
• idiopathic epiretinal membrane
• cataract
• Amsler test positive for metamorphopsia.

Exclusion Criteria:

• previous ocular interventions
• other ocular diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Outpatients; Phacoemulsification, intraocular lens implant, vitrectomy.	Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.; Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metamorphopsia	Change in spatial degree of distortion perception	Change in metamorphopsia from baseline at 180 days.
Visual Acuity	Change in LogMAR visual acuity	Change in visual acuity from baseline at 180 days
Area of central scotoma	Change in area, in square pixel, of central scotoma	Change in area of central scotoma from baseline at 180 days
Central fovea thickness	Change in fovea thickness in µm at the Sd OCT	Change in fovea thickness from baseline at 180 days

Collaborators and Investigators

• Sponsor: Clinica Oculistica dell'Università di Torino

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2015
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Vitrectomy; Epiretinal membrane; Metamorphopsia
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Retinal Diseases; Lens Diseases; Sensation Disorders; Cataract; Vision Disorders; Epiretinal Membrane
• Other Study ID Numbers: CS/526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No