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

Near Vision Clinical Trial

— TIL-001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457441
• Other study ID #: 2017-A03250-53
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: July 2018
• Source: Tilak Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Near Vision

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Tilak Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Contrast sensitivity assessment with OdySight versus with Pelli-Robson	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)
Other	Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid	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)
Other	Global functional disorders assessment with Odysight versus with OCT	To compare functional disorder(s) detected or measured by ODYSIGHT application with anatomical data (OCT: Optical coherence tomography)	1 day ( During evaluation visit)
Primary	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).	1 day ( During evaluation visit)
Secondary	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)	1 day ( During evaluation visit)