NCT01242553

Brief Summary

To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

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

October 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
Last Updated

September 28, 2017

Status Verified

November 1, 2010

Enrollment Period

11 months

First QC Date

November 15, 2010

Last Update Submit

September 26, 2017

Conditions

Normal and Ocular Pathology

Outcome Measures

Primary Outcomes (1)

  • thickness of ocular structures

Study Arms (4)

Normal

Normal results from clinical exam and free of ocular pathology.

Retina

Clinical exam results consistent with retina pathology

Glaucoma

Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.

Cornea

Clinical exam results consistent with cornea pathology.

Eligibility Criteria

Age18 Years - 80 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: Normal results from clinical exam and free of ocular pathology.
  • Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
  • Cornea: Clinical exam results consistent with cornea pathology.
  • Retina: Clinical exam results consistent with retina pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pacific Eye Specialists

Daly City, California, 94015, United States

Location

Colorado Retina Center

Denver, Colorado, 80204, United States

Location

Study Officials

  • Michael Hee, MD

    Pacific Eye Specialists

    PRINCIPAL INVESTIGATOR

  • Nalin Mehta, MD

    Colorado Retina Center

    PRINCIPAL INVESTIGATOR

  • Michael Sinai, PhD

    Optovue

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 17, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 28, 2017

Record last verified: 2010-11

Locations

US(2)