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Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions

Validation of the QuickSee Plus Device

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06883032
Enrollment
92
Registered
2025-03-19
Start date
2025-02-16
Completion date
2025-02-28
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors

Keywords

refractive errors, eyeglasses

Brief summary

At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the QuickSee Plus refractor. Subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a triple blind, case-crossover clinical trial.

Interventions

OTHERSR Eyeglasses first, AR Eyeglasses second

First Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction

OTHERAR Eyeglasses first, SR Eyeglasses second

First Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction

Sponsors

New England College of Optometry
CollaboratorOTHER
National Eye Institute (NEI)
CollaboratorNIH
PlenOptika, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale * who are aged between 18 years and 65 years

Exclusion criteria

* whose refractive error is outside of the detection range of the QuickSee Free Pro and QuickSee Plus devices: -13 D to +10 D (S) and -8 D to + 8 D (C) * who are unable to provide consent * who have undergone any eye surgery * who have a history of ocular disease * who are taking systemic drugs * who wear more than one pair of single vision eyeglasses for distance * who more than occasionally wear soft contact lenses * who are unable and unwilling to wear the eyeglasses provided by the study for the required duration

Design outcomes

Primary

MeasureTime frameDescription
Patient Preference2 weeksPatients are asked the question Which eyeglasses did you prefer?. Patient response is then recorded.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026