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OpenTrials
Completed

NCT Number: NCT06883032

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

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.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AR Eyeglasses first, SR Eyeglasses second

Other

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

SR Eyeglasses first, AR Eyeglasses second

Other

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

Primary outcomes

  1. Patient Preference

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

PlenOptika, Inc.

Industry

Collaborators

  • National Eye Institute (NEI)
  • New England College of Optometry

Registry information

Official study title

Validation of the QuickSee Plus Device

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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