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

October 20, 2016 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease - Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1140
        • Hanusch-Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

10 healthy subjects 20 macular patients

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two measurement within one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two measurement within one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vienna Institute for Research in Ocular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP3_REP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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