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

• Sponsor: Tilak Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03457441
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 29

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Near Vision	Other: Standards vision tests; Device: OdySight medical application assessment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method
• Actual Study Start Date: Mar 20, 2018
• Actual Primary Completion Date: Jul 24, 2018
• Actual Study Completion Date: Jul 24, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Near visual acuity assessment with OdySight versus with ETDRS chart [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)

Other Outcome Measures

1. Contrast sensitivity assessment with OdySight versus with Pelli-Robson [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)

2. Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid [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)

3. Global functional disorders assessment with Odysight versus with OCT [1 day ( During evaluation visit)]

   To compare functional disorder(s) detected or measured by ODYSIGHT application with anatomical data (OCT: Optical coherence tomography)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts	Paris	Ile-de-France	France	75012

Sponsors and Collaborators

• Tilak Healthcare

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tilak Healthcare
• ClinicalTrials.gov Identifier: NCT03457441
• Other Study ID Numbers: 2017-A03250-53
• First Posted: Mar 7, 2018
• Last Update Posted: Jul 27, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Jul 27, 2018