Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

NCT ID: NCT03045367

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-22

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Epiretinal Membrane Cataract Senile

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Outpatients

Phacoemulsification, intraocular lens implant, vitrectomy.

Phacoemulsification, intraocular lens implant, vitrectomy.

Intervention Type PROCEDURE

Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.

Interventions

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Phacoemulsification, intraocular lens implant, vitrectomy.

Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Oculistica dell'Università di Torino

OTHER

Sponsor Role lead

Responsible Party

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Marco DAL VECCHIO, MD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CS/526

Identifier Type: -

Identifier Source: org_study_id

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