Trial Outcomes & Findings for Comparing Low-cost Handheld Autorefractors - a Practical Approach to Measuring Refraction in Low Resource Settings (NCT NCT03456245)

Results Overview

Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction

Recruitment status

COMPLETED

Target enrollment

205 participants

Primary outcome timeframe

1-2 hours

Results posted on

2020-02-24

Participant milestones
Measure	Vision Device Validation In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
Overall Study STARTED	205
Overall Study COMPLETED	190
Overall Study NOT COMPLETED	15

Withdrawal data not reported

Comparing Low-cost Handheld Autorefractors - a Practical Approach to Measuring Refraction in Low Resource Settings

Baseline characteristics by cohort
Measure	Vision Device Validation n=374 Eyes In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
Age, Continuous	52.44 years n=190 Participants
Sex: Female, Male Female	91 Participants n=190 Participants
Sex: Female, Male Male	99 Participants n=190 Participants
Region of Enrollment India	190 participants n=190 Participants

Timeframe: 1-2 hours

Population: No difference in the analysis population

Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction

Outcome measures
Measure	Vision Device Validation n=190 Participants In the single arm of this study, all members of this group were examined using a number of mobile eyesight assessment devices. Vision device validation: Group members had their vision tested with the following devices/methods: D-EYE Portable Retinal Imaging System, Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters) Difference btw Subjective refraction and Retinomax	0.685 Diopters Interval 0.489 to 0.881
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters) Difference btw Subjective refraction and EyeNetra	-0.416 Diopters Interval -0.675 to -0.157
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters) Difference btw Subjective refraction and Quicksee	-0.039 Diopters Interval -0.25 to 0.171

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Harvard TH Chan School of Public Health

Phone: 6174320650