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

NCT03457441 | Completed

• 1 other identifier: 2017-A03250-53
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Near Vision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Near visual acuity assessment with OdySight versus with ETDRS chart

  1 day ( During evaluation visit)

Other Outcomes (3)

• Contrast sensitivity assessment with OdySight versus with Pelli-Robson

  1 day ( During evaluation visit)

• Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid

  1 day ( During evaluation visit)

• Global functional disorders assessment with Odysight versus with OCT

  1 day ( During evaluation visit)

Study Arms (3)

Near visual acuity +1.0 and +0.7 logMAR

OTHER

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; Device: OdySight medical application assessment

Near visual acuity +0.6 and +0.3 logMAR

OTHER

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; Device: OdySight medical application assessment

Near visual acuity +0.2 and +0.0 logMAR

OTHER

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; Device: OdySight medical application assessment

Interventions

Standards vision tests OTHER

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

Near visual acuity +0.2 and +0.0 logMAR; Near visual acuity +0.6 and +0.3 logMAR; Near visual acuity +1.0 and +0.7 logMAR

OdySight medical application assessment DEVICE

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

Near visual acuity +0.2 and +0.0 logMAR; Near visual acuity +0.6 and +0.3 logMAR; Near visual acuity +1.0 and +0.7 logMAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tilak Healthcare: lead

Study Sites (1)

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Paris, Île-de-France Region, 75012, France

Location

Related Publications (1)

• 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.

  PMID: 31346977 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Saddek Mohan-Saïd, MD

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 7, 2018
• Study Start: March 20, 2018
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)