- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674425
Wearable Dark-adaptometer in Normal Adult Healthy Volunteers
Evaluation of a Novel Wearable Light-emitting System for Measuring Dark-adaptation Thresholds in Normal Adult Healthy Volunteers
Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high cost, lack of easy portability, need of trained staff and a totally dark room to be operated, arbitrary testing procedures, associated time waste in clinic and patient burden to mention a few. Consequently, dark adaptometers are not routinely used as clinical tools for retinal diagnosis and monitoring despite the inherent benefits over other visual electrophysiology equipment such as the ERG system, whose cost and features may often be surplus to optometrists' requirements.
This trial will assess the dark-adaptometry testing performance of a novel light-emitting system by generating full dark-adaptation threshold functions in normal adult healthy volunteers.
The novel system has been proposed to overcome the issues associated with current instrumentation; it is semi-automatic and easy to use without the need of any skilled operator.
It is envisaged that this system could spread the practice of dark-adaptometry testing and its adoption by high-street optometrists. This will allow diagnosing a number of retinal pathologies more quickly and more reliably that, faced with an ageing population, represents a major asset to the Health Community and the NHS.
This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of 18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry testing 3 times on separate days within 3 weeks.
Testing will clarify whether by using the novel system it is possible to reproduce state-of-the-art threshold measurements as good or better than those produced by commercially-available dark-adaptometers. Threshold measurements in the elderly will be compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis contributions. Data variability and system usability will be also assessed.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Merseyside
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Liverpool, Merseyside, United Kingdom, L78TX
- University of Liverpool
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Refractive error: ≤ ±5 dioptres spherical (myopia/hyperopia) equivalent; ≤ 3 dioptres cylinder (astigmatism) equivalent.
Exclusion Criteria:
- Subjects not in age range and/or unable to fully understand the informed consent and/or unable to comply with study procedures.
- Self-reported history of depression, lack of sleep, psychiatric disorders, or neurological diseases such as Alzheimer's and Parkinson's disease.
- Self-reported history of diabetes, stroke, or multiple sclerosis.
- Self-reported hypovitaminosis A, alcoholism, liver or intestinal disease, malabsorption, protein calorie malnutrition, or sickle cell anaemia.
- Use of psychoactive drugs (including lithium salts for mood stabilisation).
- Use of dietary intake of ascorbic acid, vitamin A, B, E or other antioxidant supplements in the last two weeks.
- Recurrent practice of activities that expose the retina to ultra-violet radiation such as sailing, fishing, sunbathing or tanning saloons.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young adults (18-40)
Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.
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Older adults (50-70)
Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Rod-cone Break (RCB)
Time Frame: 40 minutes
|
RCB (time) values were determined by recording the time required for the participant to observe a light stimulus of a particular luminosity. Participants viewed the light stimuli without their optical correction. These consisted of a white (λpeak = 464 nm; chromaticity coordinates - 2° observer: x = 0.269, y = 0.324) circular test target of 0.255 mm radius, forming a visual angle of around 33°. Participants were asked to press a response button on the handheld joystick when the test target was visible and had 750 ms to make a response after target onset. Target intensity started at approximately 4.865 cd*m-2. Light stimuli were presented approximately every 2.6 s for a duration of 150 ms each. If the subject under test did not respond to the stimuli, the target intensity remained at the same initial level of approximately 4.865 cd*m-2 until the subject responded. If the subject reported perception of the light stimulus within the response window, the luminance was reduced by 0 |
40 minutes
|
Absolute Threshold
Time Frame: 40 minutes
|
Rod sensitivity (absolute threshold luminance) values measured in cd*m-2
|
40 minutes
|
Absolute Threshold Time
Time Frame: 40 minutes
|
Time taken to reach absolution threshold measured in minutes
|
40 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rachel L Williams, PhD, University of Liverpool
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UoL001185
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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