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

NCT06883032 | Completed DMC

• 2 other identifiers: QuickSee Plus Trial2R44EY025452-04
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors

Keywords

refractive errors; eyeglasses

Outcome Measures

Primary Outcomes (1)

• Patient Preference

  Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.

  2 weeks

Study Arms (2)

AR Eyeglasses, then SR Eyeglasses

OTHER

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

Other: AR Eyeglasses first, SR Eyeglasses second

SR Eyeglasses, then AR Eyeglasses

OTHER

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

Other: SR Eyeglasses first, AR Eyeglasses second

Interventions

AR Eyeglasses first, SR Eyeglasses second OTHER

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

AR Eyeglasses, then SR Eyeglasses

SR Eyeglasses first, AR Eyeglasses second OTHER

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

SR Eyeglasses, then AR Eyeglasses

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PlenOptika, Inc.: lead
• New England College of Optometry: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

New England College of Optometry (NECO) Center for Eye Care of Commonwealth

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Joseph S, Varadaraj V, Dave SR, Lage E, Lim D, Aziz K, Dudgeon S, Ravilla TD, Friedman DS. Investigation of the Accuracy of a Low-Cost, Portable Autorefractor to Provide Well-Tolerated Eyeglass Prescriptions: A Randomized Crossover Trial. Ophthalmology. 2021 Dec;128(12):1672-1680. doi: 10.1016/j.ophtha.2021.05.030. Epub 2021 Jun 7.

  PMID: 34111444 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO & co-founder

Model Details: Assignment

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: February 16, 2025
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: March 2025 - May 2025
• Access Criteria: PlenOptika, New England College of Optometry, Data Safety Monitoring Board

Locations

US (1)