Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

Epiretinal Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045367
• Other study ID #: CS/526
• Status: Completed
• Phase: N/A
• First received: February 1, 2017
• Last updated: February 3, 2017
• Start date: June 22, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: February 2017
• Source: Clinica Oculistica dell'Università di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Epiretinal Membrane
• Vision Disorders

Intervention

Procedure:
• Phacoemulsification, intraocular lens implant, vitrectomy.
Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Oculistica dell'Università di Torino

Outcome

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