NCT01370850

Brief Summary

To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 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

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

1 month

First QC Date

April 28, 2011

Last Update Submit

June 9, 2011

Conditions

HealthyGlaucoma

Keywords

Retina pathology

Outcome Measures

Primary Outcomes (1)

  • Retina measurement

    at time of study visit (day 1)

Study Arms (3)

Normal

Normal results from the clinical exam and free of ocular pathology.

Glaucoma

Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.

Retina

Clinical exam results consistent with retina pathology.

Eligibility Criteria

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

Volunteers with various ocular pathology or no ocular pathology

You may qualify if:

  • Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
  • Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
  • Retina patients will have clinical exam results consistent with retina pathology.

You may not qualify if:

  • Normal subjects will be free of any ocular pathology.
  • Glaucoma patients will be free of any ocular pathology except glaucoma.
  • Retina patients will be free of any ocular pathology except any type of retina pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Eye Specialists

Daly City, California, 94015, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Mike Sinai, PhD

    Optovue

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2011

First Posted

June 10, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

US(1)