MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients

Overview

The aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease.

Full Title of Study: “Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease – Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2016

Arms, Groups and Cohorts

  • Healthy subjects
    • Men and Women aged 18 and older Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant
  • Age-related macular degeneration patients
    • Men and Women aged 18 and older Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)

Clinical Trial Outcome Measures

Primary Measures

  • Reproducibility of retinal sensitivity measurements using microperimetry
    • Time Frame: Two measurement within one week
    • Two study measurements are scheduled within one week. Test-retest reproducibility will be assessed for retinal sensitivity using the coefficient of repeatability and Bland-Altman diagrams.

Secondary Measures

  • Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry
    • Time Frame: Two measurement within one week
    • In addition to microperimetry conventional perimetry will be performed and reproducibility of both devices will be compared.

Participating in This Clinical Trial

Inclusion criteria for healthy subjects

  • Men and Women aged 18 and older
  • Written informed consent
  • Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant

Inclusion criteria for macular disease patients

  • Men and Women aged 18 and older
  • Written informed consent
  • Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)

Any of the following will exclude a subject from the study:

  • Any opacities (corneal scar, dense cataract) which interferes with the study relevant measurements
  • Visual acuity < 0.1 (Snellen)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vienna Institute for Research in Ocular Surgery
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator – Vienna Institute for Research in Ocular Surgery
  • Overall Official(s)
    • Oliver Findl, MD, Prof., Principal Investigator, Vienna Institute for Research in Ocular Surgery

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