Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device

• Sponsor: Doheny Image Reading Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02445313
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 44.4
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration (AMD)	Device: Nidek MP-3

Detailed 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).

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Feb 12, 2019
• Actual Study Completion Date: Feb 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Control Normal, healthy participants	Device: Nidek MP-3; Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD
AMD Age-related Macular Degeneration participants	Device: Nidek MP-3; Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD

Outcome Measures

Primary Outcome Measures

1. Geographic Atrophy [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Doheny Eye Centers UCLA	Pasadena	California	United States	91105

Sponsors and Collaborators

• Doheny Image Reading Center

Investigators

• Principal Investigator: Srinivas Sadda, Doheny Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Doheny Image Reading Center
• ClinicalTrials.gov Identifier: NCT02445313
• Other Study ID Numbers: NIDEKMP3
• First Posted: May 15, 2015
• Last Update Posted: Feb 15, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy

Study Results

No Results Posted as of Feb 15, 2019