MedTrace Logo

The MORE Study: Manifest vs. Online Refraction Evaluation

NCT03313921 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-09-03

No results posted yet for this study

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.

Conditions

  • Refraction Error
  • Myopia
  • Astigmatism

Interventions

DIAGNOSTIC_TEST

Online Manifest 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.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Robert Wisse, MD PHD · UMC Utrecht

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2019-07-24
Completion
2019-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313921 on ClinicalTrials.gov