Myopia Clinical Trial
— MOREOfficial title:
The MORE Study: Manifest vs. Online Refraction Evaluation. A Clinical Validation of Online Refraction
Verified date | August 2019 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | December 2019 |
Est. primary completion date | July 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
inclusion criteria: 1. Group one: - Age: 18-40 years - Master the Dutch language - Capable to perform the tests adequately. 2. Group two: - Age: 18-40 years - Master the Dutch language - Capable to perform the tests adequately. - Diagnosis of keratoconus. Exclusion Criteria: 1. Group one: - No informed consent - Diabetes - Pregnancy or lactation - High hyperopia/myopia (>6D) - An ophthalmic history besides ametropia 2. Group two: - No informed consent - Diabetes - Pregnancy or lactation - High hyperopia/myopia (>6D) |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 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. | |
Secondary | Participant satisfaction | Questionnaire on user experience of the smartphone application. | 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. | |
Secondary | Telemetry | Duration of the online test time | 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. |
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