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Comparison of Subjective Refraction Measurement With SiVIEW Software and by an Expert

NCT04185701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2023-11-24

No results posted yet for this study

Summary

Main objective

Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.

Secondary objectives

Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.

Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.

Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.

Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.

Show that the differences obtained between two eye examination experts are consistent with those found in the literature.

Conditions

  • Eye Diseases
  • Ametropia

Interventions

OTHER

SiVIEW software

Eye examination by a technician with the SiVIEW software

OTHER

Expert

Eye examination by an expert including optimal correction in distance and near vision

Sponsors & Collaborators

  • SiVIEW

    lead INDUSTRY

Principal Investigators

  • Damien Gatinel, MD · Head of Department Ophthalmological Foundation A. de Rothschild, Paris, France

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-06-15
Completion
2023-06-15

Countries

  • France

Study Locations

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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 NCT04185701 on ClinicalTrials.gov