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Trial record 59 of 1848 for:    eye disease [DISEASE] AND ( "06/18/2011" : MAX ) [FIRST-RECEIVED-DATE] | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT04185701
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
SiVIEW

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.


Condition or disease Intervention/treatment Phase
Eye Diseases Ametropia Other: SiVIEW software Other: Expert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
  • 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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Subjective Refraction Measured With SiVIEW Software Compared to That Obtained Manually by an Expert. Monocentric Cross-sectional Study
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eye examination by expert and SiVIEW software
Eye examination by an expert and by a technician with the SiVIEW system.
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




Primary Outcome Measures :
  1. Equivalent sphere measurement [ Time Frame: At time of inclusion ]
    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.


Secondary Outcome Measures :
  1. Sphere measurement [ Time Frame: At time of inclusion ]
    The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The sphere value will be evaluated in both cases. The examination will be started in both cases on the objective measurement value obtained during the routine care examination.

  2. Cylinder measurement [ Time Frame: At time of inclusion ]
    The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The cylinder value will be evaluated in both cases. The examination will be started in both cases on the objective measurement value obtained during the routine care examination.

  3. Visual acuity [ Time Frame: At time of inclusion ]
    The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The value of visual acuity will be assessed in both cases.

  4. Consistency and relevance of the SiVIEW report [ Time Frame: At time of inclusion ]

    After each examination, the report edited by the SiVIEW software will be scored consistently on a Likert scale from 1 to 5 by an expert optometrist:

    1: very inconsistent / 2: inconsistent / 3: no opinion / 4: consistent / 5: very consistent

    After each examination, the report edited by SiVIEW software will be scored in relevance on a 5 item Likert scale by an expert optometrist:

    1: not relevant / not very relevant / no opinion / relevant / very relevant.


  5. Measurement between two optometrist experts [ Time Frame: At time of inclusion ]
    Each subject will have an eye examination conducted with an optometrist from the current care centre and by an optometrist expert mandated by SiVIEW (who is used to working at the Rothschild Foundation in clinical studies, among others). The equivalent sphere value will be evaluated in both cases.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185701


Contacts
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Contact: Laure Pichereau (+33) 638949740 laure@siview.fr

Locations
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France
Ophthalmological Foundation A. de Rothschild
Paris, France
Contact: Damien Gatinel, MD    (+33)148036482    ebarbosa@for.paris   
Sponsors and Collaborators
SiVIEW
Investigators
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Principal Investigator: Damien Gatinel, MD Head of Department Ophthalmological Foundation A. de Rothschild, Paris, France
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Responsible Party: SiVIEW
ClinicalTrials.gov Identifier: NCT04185701    
Other Study ID Numbers: SiVIEW_refraction_Paris_study
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SiVIEW:
automatic sphere measurements
eye examination
ametropia
Additional relevant MeSH terms:
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Eye Diseases
Refractive Errors