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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02941406
• Other study ID #: MP3_REP
• Status: Active, not recruiting
• Phase: N/A
• First received: October 17, 2016
• Last updated: October 20, 2016
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration

Locations

Country	Name	City	State
Austria	Hanusch-Krankenhaus	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of reproducibility of retinal sensitivity measurements assessed with microperimetry and conventional perimetry	In addition to microperimetry conventional perimetry will be performed and reproducibility of both devices will be compared.	Two measurement within one week	No