QuickSee Plus for Refractive Errors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PlenOptika, Inc.

Must not be taking: Systemic drugs

Disqualifiers: Eye surgery, Ocular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals aged 18-65 who are currently being treated for refractive errors (vision problems) and are interested in finding the most comfortable eyeglass prescription. Participants will be evaluated at the New England College of Optometry in Boston, MA.

Inclusion Criteria

Patients who have had an eye exam at the NECO Center for Eye Care of Commonwealth or Roslindale

Exclusion Criteria

Patients 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)

I am unable to give consent myself.

Patients wearing more than one pair of single vision eyeglasses for distance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive eyeglasses from either automated or subjective refraction first, followed by the alternate method

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for patient preference after wearing each pair of glasses

2 weeks

Treatment Details

Interventions

• QuickSee Plus

Trial Overview The study tests the accuracy of QuickSee Plus, an automated device for assessing refractive error, against traditional subjective refraction methods. Participants will receive two pairs of glasses based on these methods and report which they prefer after wearing each pair for a week.

Participant Groups

Group I: SR Eyeglasses, then AR Eyeglasses Experimental Treatment 1 Intervention

Subjective Refraction (SR) Eyeglasses, then Automated Refraction (AR) Eyeglasses

Group II: AR Eyeglasses, then SR Eyeglasses Experimental Treatment 1 Intervention

Automated Refraction (AR) Eyeglasses, then Subjective Refraction (SR) Eyeglasses

Who Is Running the Clinical Trial?

PlenOptika, Inc.

Lead Sponsor

Trials

2

Recruited

530+

New England College of Optometry

Collaborator

Trials

11

Recruited

13,100+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+