NCT01806402

Brief Summary

The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

3 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

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

March 5, 2013

Last Update Submit

January 20, 2014

Conditions

Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Retina thickness

    Day 1

Study Arms (2)

Retina

Having clinical diagnosis of retina pathology

Glaucoma

Having clinical diagnosis of glaucoma

Eligibility Criteria

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

Patients will have retina pathology or glaucoma.

You may qualify if:

  • At least 18 years of age
  • Able and willing to provide consent
  • Willing to complete the required examinations and visits
  • Best corrected visual acuity equal or better than 20/100
  • Retina subject must have clinical diagnosis of retinal pathology
  • Glaucoma subjects must have clinical diagnosis of glaucoma

You may not qualify if:

  • Unable to complete the required examinations and visits
  • Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment
  • Confounding pathology requiring surgical treatment or medical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pacific Eye Specialists

Daly City, California, 94015, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

West Coast Retinal Medical Group

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(3)