Refraction ErrorMORENCT03313921
The MORE Study: Manifest vs. Online Refraction Evaluation
A study testing Online Manifest Refraction in people with Refraction Error and Myopia, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Refraction Error, Myopia, Astigmatism
- What is being tested?
- Online Manifest Refraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jan 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Group one:
- Age: 18-40 years
- Master the Dutch language
- Capable to perform the tests adequately.
- Group two:
- Age: 18-40 years
Show all 9Show fewer
- Master the Dutch language
- Capable to perform the tests adequately.
- Diagnosis of keratoconus.
Who cannot join
- Group one:
- No informed consent
- Diabetes
- Pregnancy or lactation
- High hyperopia/myopia (>6D)
- An ophthalmic history besides ametropia
Show all 11Show fewer
- Group two:
- No informed consent
- Diabetes
- Pregnancy or lactation
- High hyperopia/myopia (>6D)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Refraction Error, Myopia, Astigmatism
- Being tested
- Online Manifest Refraction
- Keywords
- myopia, astigmatism, online assessment, refractive error
- Medical subject headings
- Refractive Errors, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Manifest RefractionDiagnostic test
Also called Easee online refraction
The online manifest refraction is performed with a web-based application and consists of an assessment of visual acuity, an assessment of spherical refractive error, and an assessment of cylinder refractive error. The software is a class 1 CE-approved medical device.
The automated refraction is measured with a regular office-based autorefractor device; TOPCON RM-8000.
| Study group | Role | What they receive |
|---|---|---|
| Online Manifest Refraction | Experimental | All participants will undergo three assessments of refractive error, in random order. All will perform an unsupervised manifest refraction with the use of a computer screen and their smartphone. Next, a regular manifest refraction assessment performed by an optometrist will function as active comparator. An automated refraction assessment will be performed to relate the quality and repeatability of the online refraction to another unsupervised method of refraction assessment. Receives: Diagnostic Test: Online Manifest Refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive error
The refractive error is recorded in a Sphere power (D), a Cylinder power (D) and a Cylinder axis (°). These are converted into vectors by Fourier analysis.
Measured: All three measurements (automated refraction, manifest refraction and online refraction) will be performed subsequently on the same 1 day. Data collection will take place between november 2017 and january 2018. No follow up measurements are required.
Secondary outcomes (3)
Maximum distance visual acuity
The maximum visual acuity as assessed during the refraction procedure using an ETDRS visual acuity chart and converted into logMAR values.
Measured: The visual acuity test will take place on the same 1 day as the other measurements. Data collection will take place between november 2017 and january 2018. No follow up measurements are required.
Participant satisfaction
Questionnaire on user experience of the smartphone application.
Measured: The questionnaire will be filled in on the same 1 day as the other measurements. Data collecting will take place between november 2017 and january 2018. No follow up measurements are required.
Telemetry
Duration of the online test time
Measured: Measurements of the duration of the online test will happen 1 day during the online refraction test. Collecting data will take place between November 2017 and January 2018. No follow up measurements are required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start4 Jan 2018
- Primary completion24 Jul 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refraction ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cross-sectional open-label non-inferiority assessment of a novel diagnostic entity compared to current gold-standard in two seperate groups of patients (healthy and diseased)
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert P.L. Wisse, MD PhD, UMC Utrecht
- Investigators
- Robert Wisse, MD PHD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313921
- Sponsor's protocol ID
- NL61478.041.17
- Acronym
- MORE
- Status last verified
- Aug 2019
- First submitted
- 21 Sep 2017
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wisse RPL, Muijzer MB, Cassano F, Godefrooij DA, Prevoo YFDM, Soeters N. Validation of an Independent Web-Based Tool for Measuring Visual Acuity and Refractive Error (the Manifest versus Online Refractive Evaluation Trial): Prospective Open-Label Noninferiority Clinical Trial. J Med Internet Res. 2019 Nov 8;21(11):e14808. doi: 10.2196/14808.
PubMed 31702560
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MORE Study: Manifest vs. Online Refraction Evaluation. A Clinical Validation of Online Refraction
- ClinicalTrials.gov ID
- NCT03313921
- Acronym / sponsor ID
- MORE / NL61478.041.17
- Conditions
- Refraction Error, Myopia, Astigmatism
- Keywords
- myopia, astigmatism, online assessment, refractive error
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cross-sectional open-label non-inferiority assessment of a novel diagnostic entity compared to current gold-standard in two seperate groups of patients (healthy and diseased)
| Arm | Type | Receives |
|---|---|---|
| Online Manifest Refraction | Experimental | Diagnostic Test: Online Manifest RefractionAll participants will undergo three assessments of refractive error, in random order. All will perform an unsupervised manifest refraction with the use of a computer screen and their smartphone. Next, a regular manifest refraction assessment performed by an optometrist will function as active comparator. An automated refraction assessment will be performed to relate the quality and repeatability of the online refraction to another unsupervised method of refraction assessment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Group one:
- Group two:
Key exclusion criteria (11 listed)
- Group one:
- Group two:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Manifest RefractionAlso: Easee online refractionThe online manifest refraction is performed with a web-based application and consists of an assessment of visual acuity, an assessment of spherical refractive error, and an assessment of cylinder refractive error. The software is a class 1 CE-approved medical device. The automated refraction is measured with a regular office-based autorefractor device; TOPCON RM-8000. | Diagnostic test | Online Manifest Refraction |
Primary outcome
Refractive error
Time frame: All three measurements (automated refraction, manifest refraction and online refraction) will be performed subsequently on the same 1 day. Data collection will take place between november 2017 and january 2018. No follow up measurements are required.
The refractive error is recorded in a Sphere power (D), a Cylinder power (D) and a Cylinder axis (°). These are converted into vectors by Fourier analysis.
3 secondary outcomes
Maximum distance visual acuity
Time frame: The visual acuity test will take place on the same 1 day as the other measurements. Data collection will take place between november 2017 and january 2018. No follow up measurements are required.
Participant satisfaction
Time frame: The questionnaire will be filled in on the same 1 day as the other measurements. Data collecting will take place between november 2017 and january 2018. No follow up measurements are required.
Telemetry
Time frame: Measurements of the duration of the online test will happen 1 day during the online refraction test. Collecting data will take place between November 2017 and January 2018. No follow up measurements are required.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Derived from this study: PubMed 31702560Wisse RPL, Muijzer MB, Cassano F, Godefrooij DA, Prevoo YFDM, Soeters N. Validation of an Independent Web-Based Tool for Measuring Visual Acuity and Refractive Error (the Manifest versus Online Refractive Evaluation Trial): Prospective Open-Label Noninferiority Clinical Trial. J Med Internet Res. 2019 Nov 8;21(11):e14808. doi: 10.2196/14808.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wisse, MD PHD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Manifest Refraction in people with Refraction Error and Myopia, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive error (time frame: All three measurements (automated refraction, manifest refraction and online refraction) will be performed subsequently on the same 1 day. Data collection will take place between november 2017 and january 2018. No follow up measurements are required.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.