QuickSee Plus for Refractive Errors

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: PlenOptika, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called QuickSee Plus to improve vision correction for people with refractive errors, such as nearsightedness or farsightedness. Participants will try two pairs of glasses: one made using an automated method and the other using a traditional method, to determine their preference. The goal is to identify which method provides better vision and comfort. Ideal participants have had an eye exam at the NECO Center for Eye Care and currently wear glasses for vision correction. As an unphased trial, this study allows participants to explore innovative vision correction methods and contribute to advancements in eye care.

Will I have to stop taking my current medications?

The trial excludes people who are taking systemic drugs, so you would need to stop taking those medications to participate.

What prior data suggests that the QuickSee Plus refractor is safe for evaluating refractive errors?

A previous study compared the QuickSee wavefront autorefractor, a device similar to QuickSee Plus, to traditional eye exams. The study found QuickSee to be generally safe and well-tolerated, with no serious side effects reported. This device accurately measures eye prescriptions, especially in areas with limited access to eye care.

The QuickSee Plus operates similarly, providing automated eye exam results. It has been used to check for vision changes and to help prescribe glasses, with no reports of harmful effects.

Since this trial is not in a specific phase, it likely evaluates user experiences rather than testing for new risks. This suggests that QuickSee Plus is expected to be safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about QuickSee Plus for refractive errors because it offers a fresh approach to vision correction. Unlike traditional methods, which typically rely on either automated or subjective refraction to prescribe eyeglasses, QuickSee Plus combines both techniques in a unique sequence. This dual approach aims to enhance accuracy in prescriptions and improve overall visual outcomes for patients. By potentially streamlining the process and reducing the margin of error, QuickSee Plus could lead to more personalized and effective vision correction solutions.

What evidence suggests that the QuickSee Plus refractor is effective for refractive errors?

This trial will compare the effectiveness of Automated Refraction (AR) Eyeglasses and Subjective Refraction (SR) Eyeglasses using the QuickSee Plus device. Studies have shown that the QuickSee Plus device effectively detects common eye conditions like nearsightedness, farsightedness, and astigmatism. Research indicates that QuickSee provides measurements for glasses prescriptions similar to those from traditional eye exams. In one study, QuickSee tested children and successfully completed tests 95.7% of the time. The device is known for its accuracy, even in areas with limited access to eye care. Overall, QuickSee Plus offers a reliable way to determine eye prescriptions.36789

Are You a Good Fit for This Trial?

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
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: SR Eyeglasses, then AR EyeglassesExperimental Treatment1 Intervention
Group II: AR Eyeglasses, then SR EyeglassesExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Detection of significant vision conditions in children using ...QuickSee had excellent performance for the detection of hyperopia, myopia, astigmatism and anisometropia. Also, it had high discriminatory power ...
(PDF) Evaluation of Refraction Outcomes From the ...Background: This study compared the refraction measurements of the QuickSee wavefront autorefractor with those from clinical refraction ...
Evaluation of Refraction Outcomes From the QuickSee ...This study evaluated the accuracy of QuickSee refraction compared to subjective clinical refraction in preschool and elementary school children ...
Detection of Significant Vision Conditions in Children usingAmong school-age children, testability was 95.7% (157/164). Performance of QuickSee in detecting each refractive error. Table 4 summarizes the results of the ...
Evaluation of Refraction Outcomes From the QuickSee ...About 10% of the students have refractive errors that must be corrected, and 5% have visual acuity (VA) less than 50% of normal vision [6-8].
User and safety instructionsrefractive errors and prescribing vision correction for selected subjects. In addition, QuickSee Free Pro. Keratometry also provides keratometry readings ...
Assesment of the QuickSee wavefront autorefractor for ...Only data from the right eye is reported in the analysis due to the correlation of refractive errors in both eyes. Agreement among refraction methods was ...
8.plenoptika.complenoptika.com/faqs/
Frequently Asked Questions | QuickSee Free Pro ...Yes, QuickSee allows you quickly and easily check if your patients refractive error has changed from their contact lens prescription. Vision care providers can ...
QuickSee Plus for Refractive Errors · Info for ParticipantsThis N/A medical study run by PlenOptika, Inc. needs participants to evaluate whether QuickSee Plus will have tolerable side effects & efficacy for patients ...
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