NCT01459731

Brief Summary

Collect OCT data to evaluate the range and age trend of eye measurements.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
2 countries

5 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

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

October 23, 2011

Last Update Submit

May 1, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • range of eye measurements

    Day 1

Secondary Outcomes (1)

  • age trend of eye measurements

    Day 1

Study Arms (6)

Age 18-29

Age 30-39

Age 40-49

Age 50-59

Age 60-69

Age 70+

Eligibility Criteria

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

No eye disease

You may qualify if:

  • At least 18 years of age
  • Able and willing to provide consent
  • Able and willing to complete the required examininations and visit
  • Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye
  • Best corrected visual acuity of 20/30 or better in each eye

You may not qualify if:

  • History of leukemia, AIDS, dementia or multiple sclerosis
  • Concomitant use of hydroxycloroquine or chloroquine
  • Family history of glaucoma among first degree relatives
  • Intraocular pressure of 22mm Hg or greater in either eye
  • Unreliable or abnormal visual field
  • Active ocular disease
  • Previously diagnosed with glaucoma or glaucoma suspect
  • Congenital ocular abnormalities
  • Previous intra-ocular surgery or laser treatment (other than refractive surgery or uncomplicated cataract surgery greater than 6 months previously)
  • Anatomic narrow angle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

College of Optometry, Western University of Health Sciences

Pomona, California, 91766, United States

Location

Buena Vista Eye Care

San Jose, California, 95112, United States

Location

Illinois Eye Institute

Chicago, Illinois, 60616, United States

Location

Institute of Ophthalmology, University College London

London, England, EC1V 9EL, United Kingdom

Location

Study Officials

  • George Comer, OD, MBA

    Southern California College of Optometry at Marshall B. Ketchum University

    PRINCIPAL INVESTIGATOR
  • Michael Chaglasian, OD

    Illinois Eye Institute

    PRINCIPAL INVESTIGATOR
  • Jorge Cuadros, OD, PhD

    Buena Vista Eye Care

    PRINCIPAL INVESTIGATOR
  • David Garway-Heath, MD

    Institute of Ophthalmology, University College London

    PRINCIPAL INVESTIGATOR
  • Pinakin G Davey, OD, PhD

    Western University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 23, 2011

First Posted

October 26, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations