Clinical trial NCT02674425: Wearable Dark-adaptometer in Normal Adult Healthy Volunteers
Official title: Evaluation of a Novel Wearable Light-emitting System for Measuring Dark-adaptation Thresholds in Normal Adult Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Photoreceptor Sensitivity Thresholds
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers with no prior/current eye problems or family history of genetic eye diseases and good general health.

Brief summary: 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.

Detailed description: All details elsewhere in the documentation

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Rod-cone Break (RCB)
timeFrame: 40 minutes
measure: Absolute Threshold
timeFrame: 40 minutes
measure: Absolute Threshold Time
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Rachel L Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: