Healthy VolunteersNCT01207817
Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
An observational study of Healthy Volunteers, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Pupillometry
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volinteers
Who may be able to join
- healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Pupillometry
- Keywords
- a light flash in each eye for a total of 48 measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryOther
Pupillometry readings will be taken at low, intermediate and high ambient light
| Study group | Role | What they receive |
|---|---|---|
| no condition | no condition - healthy volunteers Receives: Other: Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary light reflex: amplitude, latency, maximum constriction velocity, mean constriction velocity and dilation velocity during different levels of ambient light
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence W Chinn, MD, Principal investigator, UMDNJ-NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207817
- Sponsor's protocol ID
- 0120090181
- Status last verified
- Sep 2010
- First submitted
- 25 Jan 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
- ClinicalTrials.gov ID
- NCT01207817
- Acronym / sponsor ID
- 0120090181
- Conditions
- Healthy Volunteers
- Keywords
- a light flash in each eye for a total of 48 measurements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no condition | – | Other: Pupillometryno condition - healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volinteers
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PupillometryPupillometry readings will be taken at low, intermediate and high ambient light | Other | no condition |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2010.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence W Chinn, MD principal investigator
UMDNJ-NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2010.