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

February 12, 2019 updated by: Doheny Image Reading Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

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

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Doheny Eye Centers UCLA

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort A will consist of patients with AMD, recruited by PI when they come in to the clinic, with whom we will conduct medical record review and imaging procedures, using one of the research devices.

Cohort B will consist of control subject with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.

Description

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 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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geographic Atrophy
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Doheny Image Reading Center

Investigators

  • Principal Investigator: Srinivas Sadda, Doheny Eye Institute

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

June 1, 2015

Primary Completion (ACTUAL)

February 12, 2019

Study Completion (ACTUAL)

February 12, 2019

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (ESTIMATE)

May 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDEKMP3

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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