NCT01600261

Brief Summary

Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1 month

First QC Date

May 14, 2012

Last Update Submit

June 27, 2012

Conditions

Eye Disease

Keywords

without eye disease

Outcome Measures

Primary Outcomes (1)

  • proportion of clinically useful images

    Day 1

Study Arms (1)

eye exam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study subjects shall be recruited from the practice of the principal investigator (PI).

You may qualify if:

  • At least 18 years of age
  • Able and willing to complete the required examination

You may not qualify if:

  • Spherical Equivalent outside -12 diopter to +15 diopter
  • Without lens
  • Inability to fixate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Livermore Optometry Group

Livermore, California, 94550, United States

Location

Buena Vista Eye Care

San Jose, California, 95112, United States

Location

MeSH Terms

Conditions

Eye Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 17, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(2)