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Clinical Trials/NCT03045367
NCT03045367CompletedNot Applicable

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

Clinica Oculistica dell'Università di Torino0 sites30 target enrollmentStarted: June 22, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Primary Endpoint
Metamorphopsia

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
55 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • previous ocular interventions
  • other ocular diseases.

Outcomes

Primary Outcomes

Metamorphopsia

Time Frame: Change in metamorphopsia from baseline at 180 days.

Change in spatial degree of distortion perception

Area of central scotoma

Time Frame: Change in area of central scotoma from baseline at 180 days

Change in area, in square pixel, of central scotoma

Visual Acuity

Time Frame: Change in visual acuity from baseline at 180 days

Change in LogMAR visual acuity

Central fovea thickness

Time Frame: Change in fovea thickness from baseline at 180 days

Change in fovea thickness in µm at the Sd OCT

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Clinica Oculistica dell'Università di Torino
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marco DAL VECCHIO, MD

Medical Doctor

Clinica Oculistica dell'Università di Torino

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