Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

Completed

• Conditions: Epiretinal Membrane; Cataract Senile
• Interventions: Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.

• Registration Number: NCT03045367
• Lead Sponsor: Clinica Oculistica dell'Università di Torino

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-22
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatients	Phacoemulsification, intraocular lens implant, vitrectomy.	Phacoemulsification, intraocular lens implant, vitrectomy.

Primary Outcome Measures

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