The MORE Study: Manifest vs. Online Refraction Evaluation
MORE
1 other identifier
interventional
150
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedStudy Start
First participant enrolled
January 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 3, 2019
August 1, 2019
1.6 years
September 21, 2017
August 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 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
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
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.
Study Arms (1)
Online Manifest Refraction
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Group one:
- Age: 18-40 years
- Master the Dutch language
- Capable to perform the tests adequately.
- Group two:
- Age: 18-40 years
- Master the Dutch language
- Capable to perform the tests adequately.
- Diagnosis of keratoconus.
You may not qualify if:
- Group one:
- No informed consent
- Diabetes
- Pregnancy or lactation
- High hyperopia/myopia (\>6D)
- An ophthalmic history besides ametropia
- Group two:
- No informed consent
- Diabetes
- Pregnancy or lactation
- High hyperopia/myopia (\>6D)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center Utrecht
Utrecht, Netherlands
Related Publications (1)
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.
PMID: 31702560DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Wisse, MD PHD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist
Study Record Dates
First Submitted
September 21, 2017
First Posted
October 18, 2017
Study Start
January 4, 2018
Primary Completion
July 24, 2019
Study Completion
December 1, 2019
Last Updated
September 3, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share