NCT01986478

Brief Summary

To collect data for a reference database.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

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

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

November 11, 2013

Last Update Submit

June 6, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Retinal Thickness

    Day 1

Study Arms (1)

Normal

Normal results from clinical exam and free of ocular pathology

Eligibility Criteria

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

Subjects that are Normal

You may qualify if:

  • Subjects 18 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • Subjects presenting at the site with normal eyes (eyes without pathology)
  • IOP ≤ 21 mmHg bilaterally
  • BCVA 20/40 or better (each eye)
  • Both eyes must be free of eye disease

You may not qualify if:

  • Subjects unable to tolerate ophthalmic imaging
  • Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  • HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
  • HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 33% or false positives \> 25%, or false negatives \> 25%
  • Presence of any ocular pathology except for cataract
  • Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
  • Narrow angle
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Horizon Eye Specialist & Laser Center

Scottsdale, Arizona, 85054, United States

Location

Valley Eyecare Center

Livermore, California, 94550, United States

Location

Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Western University of Health Sciences

Pomona, California, 91716, United States

Location

Stat University of New York College of Optometry

New York, New York, 10036, United States

Location

Study Officials

  • Michael Sinai, PhD

    Senior Manager Product Planning Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(5)