NCT02445313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3.7 years

First QC Date

May 13, 2015

Last Update Submit

February 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Geographic Atrophy

    1 year

Study Arms (2)

Control

Normal, healthy participants

Device: Nidek MP-3

AMD

Age-related Macular Degeneration participants

Device: Nidek MP-3

Interventions

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

AMDControl

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Normal, healthy participants and patients with AMD

You may not qualify if:

  • Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
  • Participants who are unable to maintain retinal fixation on a specified target
  • Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
  • Patients with media opacity which preclude high quality imaging will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doheny Eye Centers UCLA

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Srinivas Sadda

    Doheny Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 15, 2015

Study Start

June 1, 2015

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations