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.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Refractive outcomes
Values of the sphere, cylinder and axis components, obtained by the following
tests: 1: automatic, 2: manifest and 3: online (Easee). These are converted
into vectors by Fourier analysis.
Secondary outcome
- Visual acuity (converted into LogMAR values for statistical analysis)
- Gender (men/women)
- Telemetry (duration of the test in minutes)
- Age (in years)
- Degree of ametropia (in diopters)
Background summary
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 has been 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)). Automated refraction, another refraction
method, is 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 in other countries
besides the United States of America (USA) or are 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 by 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. The same
applies to SVOne; this method uses a Hartmann-Shack wavefront aberrometer which
you can attach to a smartphone (Ohlendorf, Leube & Wahl (2016)). Another online
refraction method is 6over6, but this method has not been released yet (6over6,
(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)).
At this day, digitalization is already affecting our way of living. 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.
Study objective
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.
Study design
Part one and part two: prospective comparative monocenter study
Study burden and risks
not applicable
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Age: 18-40 years
Master the Dutch language
Capable to perform the tests adequately.
Exclusion criteria
No informed consent
Diabetes
High hypermetropia/myopia
Mental incompetence
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL61478.041.17 |