Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method (TIL-001)

July 26, 2018 updated by: Tilak Healthcare

Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method

This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75012
        • Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Able to correctly distinguish the body laterality (left and right)
  • Able to recognize alphabet letters and read French
  • Affiliated to or beneficiary of the French health care system
  • Signed/written informed consent
  • Subject presenting a level of visual acuity of one of his eyes that fits to one of the pre-set cohort (visual acuity between +1.0 and +0.7 logMAR, between +0.6 and +0.3 logMAR or between +0.2 and 0.0 logMAR); the two eyes can be included in two different cohorts.

Exclusion Criteria:

  • Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
  • Pregnant and breastfeeding women.
  • Subject not considered by the investigator or designee to correctly use OdySight modules after the training session

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Near visual acuity +1.0 and +0.7 logMAR
Subjects with near visual acuity between +1.0 and +0.7 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
Other: Standards vision tests
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
Device: OdySight medical application assessment
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
OTHER: Near visual acuity +0.6 and +0.3 logMAR
Subjects with near visual acuity between +0.6 and +0.3 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
Other: Standards vision tests
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
Device: OdySight medical application assessment
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
OTHER: Near visual acuity +0.2 and +0.0 logMAR
Subjects with near visual acuity between +0.2 and +0.0 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
Other: Standards vision tests
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
Device: OdySight medical application assessment
Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near visual acuity assessment with OdySight versus with near visual acuity chart
Time Frame: 1 day ( During evaluation visit)
To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT (NVA module) and a standardized method (Sloan ETDRS near vision letter chart).
1 day ( During evaluation visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near visual acuity assessment with OdySight versus with ETDRS chart
Time Frame: 1 day ( During evaluation visit)
To assess the relation between the ETDRS visual acuity at a 4-meter distance and near visual acuity evaluated with ODYSIGHT (NVA module)
1 day ( During evaluation visit)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast sensitivity assessment with OdySight versus with Pelli-Robson
Time Frame: 1 day ( During evaluation visit)
To compare the smartphone based evaluation of the contrast sensitivity with ODYSIGHT (contrast sensitivity module) and a standardized method (Pelli-Robson chart)
1 day ( During evaluation visit)
Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid
Time Frame: 1 day ( During evaluation visit)
To compare the smartphone based evaluation of the Amsler Grid with ODYSIGHT (Amsler grid module) and standardized methods (paper Amsler Grid)
1 day ( During evaluation visit)
Global functional disorders assessment with Odysight versus with OCT
Time Frame: 1 day ( During evaluation visit)
To compare functional disorder(s) detected or measured by ODYSIGHT application with anatomical data (OCT: Optical coherence tomography)
1 day ( During evaluation visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tilak Healthcare

Investigators

  • Principal Investigator: Saddek Mohan-Saïd, MD, Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2018

Primary Completion (ACTUAL)

July 24, 2018

Study Completion (ACTUAL)

July 24, 2018

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03250-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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