Myopia Clinical Trial
Official title:
The MORE Study: Manifest vs. Online Refraction Evaluation. A Clinical Validation of Online Refraction
The assessment of the refractive state of the eye is a fundamental and important part of
ophthalmic and optometric clinical practice. The development of an unsupervised online
subjective refraction method makes a refraction more accessible and can be quite cost-saving.
In this study, the investigators want to validate an online refraction method which was
recently created in the Netherlands. The study comprises two different set of participants:
Part one contains fifty healthy volunteers, 18-40 years of age, with a refractive error and
no other ophthalmic pathology. Part two contains fifty patients with an ophthalmic pathology.
The online refraction outcomes will be compared to a manifest refraction and automated
refraction in a cross-sectional study design.
Uncorrected refractive errors cause significant economic implications in both high and low
income countries in terms of the loss of potential productivity (Williams et al. (2015)). The
prevalence of uncorrected refractive errors is, despite of the available clinical services,
still huge; visual impairment is in 42 percent of the cases the result of an uncorrected
refractive error worldwide (Williams et al. (2015)). Even in high income countries, this
issue remains prevalent. Therefore, the access to the available clinical services has to be
simplified. The development of an online refraction method will make a refraction more
accessible for patients and can be cost-saving. Clinicians can easily take an online method
to places where it's needed for example in low income countries.
There are several methods to measure a refractive error. The 'golden standard' to prescribe
spectacles is a manifest refraction (Thibos, Hong, Bradley & Applegate (2004)). This method
was already described by F.C. Donders in 1864 and is performed with trial lenses and a visual
acuity chart to measure the refraction error (Donders (1864)). An automated refraction is a
quick routine machine based assessment, mainly used as a starting point for a manifest
refraction and is based on retinoscopy (Nissman et al., (2004)).
At the moment, several online refraction methods are available. However, these methods are
not scientifically validated, unavailable outside the United States of America (USA) or not
designed for customers. One of these online refraction methods is Opternative (Opternative
(2017)). Opternative is currently used in the USA and is still developing (Opternative
(2017)). It's a self-directed online refraction method using a computer-based response to
presented stimuli with the use of a smartphone and a computer. Another method is EyeNetra
(EyeNetra (2017) & Ohlendorf, Leube & Wahl (2016)). The use of this method is limited due to
the need of special equipment such as a portable autorefractor, an autolensometer and a
phoropter. Therefore, EyeNetra is mainly designed for optometrists and ophthalmologists for
low-income populations. The same applies to SVOne; this method uses a Hartmann-Shack
wavefront aberrometer which the user can attach to a smartphone (Ohlendorf, Leube & Wahl
(2016)). Other online refraction methods are 6over6, but this method has not been released
yet (6over6, (2017)), and Warby Parker (Warby Parker, (2017)).
There are also online visual acuity tests to measure the visual acuity only. The mobile
devices to test the visual acuity are PeekVision, 6over6, Opternative, Eyenetra and DigiSight
(Ludwig et al., (2016)).
Currently, digitalization is affecting our way of life. Technology can be used to design
products to easily determine if someone has a refractive error. This can, in the future,
solve a big part of the problem of uncorrected refractive errors and the leading cause of
blindness worldwide. The aim of this study is to validate a recently created online
refraction method by comparing the outcomes of the online refraction method with the 'golden
standard' manifest refraction.
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