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OpenTrials
Completed

NCT Number: NCT03045367

Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane 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.

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Key information

Conditions

Epiretinal Membrane Cataract Senile Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phacoemulsification, intraocular lens implant, vitrectomy.

Procedure

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

Primary outcomes

  1. Metamorphopsia

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

    Change in spatial degree of distortion perception

  2. Visual Acuity

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

    Change in LogMAR visual acuity

  3. 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

  4. Central fovea thickness

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

    Change in fovea thickness in µm at the Sd OCT

Sponsors and collaborators

Lead sponsor

Clinica Oculistica dell'Università di Torino

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2017
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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