MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients
Reproducibility of Microperimetry Using Nidek MP3 (Microperimeter 3) in Healthy Subjects and Patients With Macular Disease - Pilot Study
1 other identifier
observational
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 21, 2016
October 1, 2016
6 months
October 17, 2016
October 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reproducibility of retinal sensitivity measurements using microperimetry
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 Outcomes (1)
Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry
Two measurement within one week
Study Arms (2)
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)
Eligibility Criteria
10 healthy subjects 20 macular patients
You may qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanusch-Krankenhaus
Vienna, Vienna, A-1140, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, MD, Prof.
Vienna Institute for Research in Ocular Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 21, 2016
Study Start
July 1, 2015
Primary Completion
January 1, 2016
Study Completion
December 1, 2016
Last Updated
October 21, 2016
Record last verified: 2016-10