search
Back to results

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

Primary Purpose

Near Vision

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standards vision tests
OdySight medical application assessment
Sponsored by
Tilak Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Near Vision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Near visual acuity +1.0 and +0.7 logMAR

Near visual acuity +0.6 and +0.3 logMAR

Near visual acuity +0.2 and +0.0 logMAR

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Near visual acuity assessment with OdySight versus with near visual acuity chart
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).

Secondary Outcome Measures

Near visual acuity assessment with OdySight versus with ETDRS chart
To assess the relation between the ETDRS visual acuity at a 4-meter distance and near visual acuity evaluated with ODYSIGHT (NVA module)

Full Information

First Posted
February 20, 2018
Last Updated
July 26, 2018
Sponsor
Tilak Healthcare
search

1. Study Identification

Unique Protocol Identification Number
NCT03457441
Brief Title
Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method
Acronym
TIL-001
Official Title
Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tilak Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Near Vision

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Near visual acuity +1.0 and +0.7 logMAR
Arm Type
Other
Arm Description
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
Arm Title
Near visual acuity +0.6 and +0.3 logMAR
Arm Type
Other
Arm Description
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
Arm Title
Near visual acuity +0.2 and +0.0 logMAR
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Standards vision tests
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
OdySight medical application assessment
Intervention Description
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
Primary Outcome Measure Information:
Title
Near visual acuity assessment with OdySight versus with near visual acuity chart
Description
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).
Time Frame
1 day ( During evaluation visit)
Secondary Outcome Measure Information:
Title
Near visual acuity assessment with OdySight versus with ETDRS chart
Description
To assess the relation between the ETDRS visual acuity at a 4-meter distance and near visual acuity evaluated with ODYSIGHT (NVA module)
Time Frame
1 day ( During evaluation visit)
Other Pre-specified Outcome Measures:
Title
Contrast sensitivity assessment with OdySight versus with Pelli-Robson
Description
To compare the smartphone based evaluation of the contrast sensitivity with ODYSIGHT (contrast sensitivity module) and a standardized method (Pelli-Robson chart)
Time Frame
1 day ( During evaluation visit)
Title
Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid
Description
To compare the smartphone based evaluation of the Amsler Grid with ODYSIGHT (Amsler grid module) and standardized methods (paper Amsler Grid)
Time Frame
1 day ( During evaluation visit)
Title
Global functional disorders assessment with Odysight versus with OCT
Description
To compare functional disorder(s) detected or measured by ODYSIGHT application with anatomical data (OCT: Optical coherence tomography)
Time Frame
1 day ( During evaluation visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddek Mohan-Saïd, MD
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31346977
Citation
Brucker J, Bhatia V, Sahel JA, Girmens JF, Mohand-Said S. Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmol Ther. 2019 Sep;8(3):461-476. doi: 10.1007/s40123-019-0203-9. Epub 2019 Jul 25.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs