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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02445313
Other study ID # NIDEKMP3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date February 12, 2019

Study information

Verified date February 2019
Source Doheny Image Reading Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.


Description:

To test the quality of images from the Nidek MP-3 device and to measure Geographic Atrophy (GA) in patients with Age-related Macular Degeneration (AMD).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 12, 2019
Est. primary completion date February 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Normal, healthy participants and patients with AMD

Exclusion Criteria:

1. Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging

2. Participants who are unable to maintain retinal fixation on a specified target

3. Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place

4. Patients with media opacity which preclude high quality imaging will be excluded.

5. Exclusion criteria include vulnerable patients; patients under 18, pregnant, economically and educationally disadvantaged, decision impaired, or homeless people. We exclude pregnant women because pregnancy often can alter eye anatomy.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Nidek MP-3
Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD

Locations

Country Name City State
United States Doheny Eye Centers UCLA Pasadena California

Sponsors (1)

Lead Sponsor Collaborator
Doheny Image Reading Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geographic Atrophy 1 year
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