- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01207817
Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
September 22, 2010 updated by: University of Medicine and Dentistry of New Jersey
The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response.
Study Overview
Detailed Description
Evaluation of the pupillary response is an underemphasized aspect of the assessment of visual function.
The pupillary light reflex is one of the few objective indicators of afferent input from the retina and optic nerve.
Since the pupillary light reflex is processed through the retina, it may be used to assess visual integrity (1).
Pupillometry is a reliable technology capable of providing repetitive data on quantitative pupillary function in states of health and disease (2).
Amplitude, latency, maximum constriction velocity, mean constriction velocity, and dilation velocity are measured using the Neuroleptics pupillometer.
The effects of varying levels of ambient light on these parameters of the pupillary response have not been extensively studied.
The purpose of this investigation is to determine the effects of varying luminescent levels on the pupillary response.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
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Newark, New Jersey, United States, 07101
- UMDNJ-University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volinteers
Description
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
no condition
no condition - healthy volunteers
|
Pupillometry readings will be taken at low, intermediate and high ambient light
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pupillary light reflex: amplitude, latency, maximum constriction velocity, mean constriction velocity and dilation velocity during different levels of ambient light
Time Frame: 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lawrence W Chinn, MD, Umdnj-Njms
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 25, 2010
First Submitted That Met QC Criteria
September 22, 2010
First Posted (Estimate)
September 23, 2010
Study Record Updates
Last Update Posted (Estimate)
September 23, 2010
Last Update Submitted That Met QC Criteria
September 22, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 0120090181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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