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

NCT04185701 | Completed

• 1 other identifier: SiVIEW_refraction_Paris_study
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

automatic sphere measurements; eye examination; ametropia

Outcome Measures

Primary Outcomes (1)

• Equivalent sphere measurement

  The subject will have an eye exam with SiVIEW and an examination by an optometrist expert. The equivalent sphere value will be evaluated in both cases.

  At time of inclusion

Secondary Outcomes (5)

• Sphere measurement

  At time of inclusion

• Cylinder measurement

  At time of inclusion

• Visual acuity

  At time of inclusion

• Consistency and relevance of the SiVIEW report

  At time of inclusion

• Measurement between two optometrist experts

  At time of inclusion

Study Arms (1)

Eye examination by expert and SiVIEW software

EXPERIMENTAL

Eye examination by an expert and by a technician with the SiVIEW system.

Other: SiVIEW software; Other: Expert

Interventions

SiVIEW software OTHER

Eye examination by a technician with the SiVIEW software

Eye examination by expert and SiVIEW software

Expert OTHER

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

Eye examination by expert and SiVIEW software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subject with visual AV on each eye \>= 8/10 and no amblyopia
• subject with normal environmental transparency
• subject with a healthy fundus that does not reveal major abnormalities that may affect vision
• subject able to read the letters of the Latin alphabet
• subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
• non-diabetic subject
• non nystagmic subject
• non-strabic subject
• subject who has not had eye surgery less than 1 year old

You may not qualify if:

• subject with a topography showing an anomaly (keratoconus type or other)

Sponsors & Collaborators

• SiVIEW: lead

Study Sites (1)

Ophthalmological Foundation A. de Rothschild

Paris, France

Location

MeSH Terms

Conditions

Eye Diseases; Refractive Errors

Study Officials

• Damien Gatinel, MD

  Head of Department Ophthalmological Foundation A. de Rothschild, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Eye examination by an expert including optimal correction in distance and near vision * Eye examination by a technician with the SiVIEW system * Analysis of the SiVIEW report by the expert who conducted the second review

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 4, 2019
• Study Start: November 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)