Photoreceptor Sensitivity Thresholds Clinical Trial
Official title:
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.
n/a
Observational Model: Case-Only