Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
| Tracking Information | |||||
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| First Received Date ICMJE | January 25, 2010 | ||||
| Last Updated Date | September 22, 2010 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01207817 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Ambient Light on the Parameters of the Pupillary Light Reflex | ||||
| Official Title ICMJE | Effect of Ambient Light on the Parameters of the Pupillary Light Reflex | ||||
| Brief Summary | The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy volinteers |
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| Condition ICMJE | Healthy Volunteers | ||||
| Intervention ICMJE | Other: Pupillometry
Pupillometry readings will be taken at low, intermediate and high ambient light |
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| Study Group/Cohort (s) | no condition
no condition - healthy volunteers
Intervention: Other: Pupillometry |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | February 2010 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01207817 | ||||
| Other Study ID Numbers ICMJE | 0120090181 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lawrence Chin, MD, UMDNJ | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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