Trial Outcomes & Findings for Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye (NCT NCT03929588)

Results Overview

Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

230 participants

Primary outcome timeframe

Through study completion, an average of 5 months

Results posted on

2022-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
Overall Study STARTED	230
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Refraction With a Hand-held Device Supported by Mobile App. n=230 Participants BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
Age, Categorical <=18 years	0 Participants n=230 Participants
Age, Categorical Between 18 and 65 years	230 Participants n=230 Participants
Age, Categorical >=65 years	0 Participants n=230 Participants
Sex: Female, Male Female	115 Participants n=230 Participants
Sex: Female, Male Male	115 Participants n=230 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 5 months

Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.

Outcome measures

Outcome measures
Measure	All Participants n=143 Participants BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years BCVA handheld device	0.06 logMAR Interval 0.04 to 0.08
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years BCVA manual refraction	0.02 logMAR Interval 0.0 to 0.04
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years BCVA automated refraction	0.03 logMAR Interval 0.01 to 0.05

Adverse Events

Refraction With a Hand-held Device Supported by Mobile App.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP Science and Technology

EyeQue

Phone: 5104558168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place