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Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045367
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Marco DAL VECCHIO, MD, 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.

Condition or disease Intervention/treatment
Epiretinal Membrane Cataract Senile Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 180 Days
Official Title: Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery
Actual Study Start Date : June 22, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Outpatients
Phacoemulsification, intraocular lens implant, vitrectomy.
Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.
Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient of all gender, with complain of visual impairment and distortion
Criteria

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.

Additional Information:

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Responsible Party: Marco DAL VECCHIO, MD, Medical Doctor, Clinica Oculistica dell'Università di Torino
ClinicalTrials.gov Identifier: NCT03045367    
Other Study ID Numbers: CS/526
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco DAL VECCHIO, MD, Clinica Oculistica dell'Università di Torino:
Metamorphopsia
Epiretinal membrane
Vitrectomy
Additional relevant MeSH terms:
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Vision Disorders
Cataract
Epiretinal Membrane
Lens Diseases
Eye Diseases
Retinal Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms