Refractive ErrorsNCT06883032
Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions
A study testing AR Eyeglasses first, SR Eyeglasses second and SR Eyeglasses first, AR Eyeglasses second in people with Refractive Errors, run by PlenOptika, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- AR Eyeglasses first, SR Eyeglasses second and SR Eyeglasses first, AR Eyeglasses second
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2025to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New England College of Optometry (NECO) Center for Eye Care of Commonwealth
Boston, Massachusetts, 02215
About this study
Official title: Validation of the QuickSee Plus Device
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
- Being tested
- AR Eyeglasses first, SR Eyeglasses second, SR Eyeglasses first, AR Eyeglasses second
- Keywords
- refractive errors, eyeglasses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR Eyeglasses first, SR Eyeglasses secondOther
First Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction
SR Eyeglasses first, AR Eyeglasses secondOther
First Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction
| Study group | Role | What they receive |
|---|---|---|
| AR Eyeglasses, then SR Eyeglasses | Other | Automated Refraction (AR) Eyeglasses, then Subjective Refraction (SR) Eyeglasses Receives: Other: AR Eyeglasses first, SR Eyeglasses second |
| SR Eyeglasses, then AR Eyeglasses | Other | Subjective Refraction (SR) Eyeglasses, then Automated Refraction (AR) Eyeglasses Receives: Other: SR Eyeglasses first, AR Eyeglasses second |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start16 Feb 2025
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- PlenOptika, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New England College of Optometry, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Shivang R. Dave, PhD, PlenOptika, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883032
- Sponsor's protocol ID
- QuickSee Plus Trial
- Other IDs
- 2R44EY025452-04
- Status last verified
- Jul 2025
- First submitted
- 12 Mar 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34111444
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the QuickSee Plus Device
- ClinicalTrials.gov ID
- NCT06883032
- Acronym / sponsor ID
- QuickSee Plus Trial
- Conditions
- Refractive Errors
- Keywords
- refractive errors, eyeglasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- PlenOptika, Inc.Industry (pharma, biotech, devices)
- Collaborators
- New England College of Optometry, National Eye Institute (NEI)
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| AR Eyeglasses, then SR Eyeglasses | Other | Other: AR Eyeglasses first, SR Eyeglasses secondAutomated Refraction (AR) Eyeglasses, then Subjective Refraction (SR) Eyeglasses |
| SR Eyeglasses, then AR Eyeglasses | Other | Other: SR Eyeglasses first, AR Eyeglasses secondSubjective Refraction (SR) Eyeglasses, then Automated Refraction (AR) Eyeglasses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR Eyeglasses first, SR Eyeglasses secondFirst Eyeglasses based on Automated Refraction, Second Eyeglasses based on Subjective Refraction | Other | AR Eyeglasses, then SR Eyeglasses |
| SR Eyeglasses first, AR Eyeglasses secondFirst Eyeglasses based on Subjective Refraction, Second Eyeglasses based on Automated Refraction | Other | SR Eyeglasses, then AR Eyeglasses |
Primary outcome
Patient Preference
Time frame: 2 weeks
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 34111444Joseph 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR Eyeglasses first, SR Eyeglasses second and SR Eyeglasses first, AR Eyeglasses second in people with Refractive Errors, run by PlenOptika, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Preference (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.