NCT01207817

Brief Summary

The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

January 25, 2010

Last Update Submit

September 22, 2010

Conditions

Healthy Volunteers

Keywords

a light flash in each eye for a total of 48 measurements

Outcome Measures

Primary Outcomes (1)

  • pupillary light reflex: amplitude, latency, maximum constriction velocity, mean constriction velocity and dilation velocity during different levels of ambient light

    Pupillometry readings will be taken at 3 potential light readings low light, intermediate light and high ambient light. A total of 48 readings will be done. All parameters will be done at one sitting and will take approximately 45 minutes to complete.

Study Arms (1)

no condition

no condition - healthy volunteers

Other: Pupillometry

Interventions

PupillometryOTHER

Pupillometry readings will be taken at low, intermediate and high ambient light

no condition

Eligibility Criteria

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

Healthy volinteers

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • recent bout of conjunctivitis or infection in the eye recent eye surgery seizure disorder unable to lie flat for 30 minutes known history of eye disease which cannot be corrected with lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ-University Hospital

Newark, New Jersey, 07101, United States

Location

Study Officials

  • Lawrence W Chinn, MD

    UMDNJ-NJMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2010

First Posted

September 23, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 23, 2010

Record last verified: 2010-09

Locations

US(1)