Visual AcuityNCT05259163
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
A study testing LFR-260 portable phoropter and Traditional phoropter (SOC) in people with Visual Acuity and Astigmatism, run by Evolution Optiks Limited at 2 sites in United States.
Trial summary
The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity, Astigmatism, Anisometropia
- What is being tested?
- LFR-260 portable phoropter and Traditional phoropter (SOC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2022to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
- The participant is a male or female between the ages of 12 and 65 (inclusive).
- The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
- The participant is free of ocular and systemic abnormalities that might affect visual functions.
Who cannot join
- The participant has diabetes mellitus (Type 1 or 2).
- The participant has an autoimmune condition.
- The participant is pregnant (self-reported).
- The participant has an active corneal or conjunctival infection.
- The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
- The participant has diabetic retinopathy.
Show all 16Show fewer
- The participant has glaucoma or ocular hypertension.
- The participant has macular degeneration.
- The participant has had a previous ocular surgery.
- The participant has ocular and systemic diseases or abnormalities that might affect visual functions.
- The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.
- The participant has a history of AMD (age macular degeneration).
- The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment.
- The participant will not be able to complete questionnaires.
- The participant is currently in an investigational study for a similar purpose.
- The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gold Coast Optometric Vision
Oyster Bay, New York, 11771
MCPHS
Worcester, Massachusetts, 01608
About this study
Official title: An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.
- Conditions
- Visual Acuity, Astigmatism, Anisometropia
- Being tested
- LFR-260 portable phoropter, Traditional phoropter (SOC)
- Keywords
- Ocular
- Medical subject headings
- Astigmatism, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFR-260 portable phoropterDevice
Portable unit to evaluate visual refractive state of the patient
Traditional phoropter (SOC)Device
Standard unit for evaluating visual refractive state of the patient
| Study group | Role | What they receive |
|---|---|---|
| Group 1: LFR-260 first, then traditional phoropter | Experimental | The LFR-260 was administered first in this group, followed by the traditional phoropter. The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams. The traditional phoropter is intended to be used for distance vision testing in any environment. Receives: Device: LFR-260 portable phoropter; Device: Traditional phoropter (SOC) |
| Group II: Traditional Phoropter first, then LFR-260 | Active comparator | The traditional phoropter was administered first in this group, followed by the traditional phoropter. The traditional phoropter is intended to be used for distance vision testing in any environment. The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams. Receives: Device: LFR-260 portable phoropter; Device: Traditional phoropter (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of LFR260 on Visual Acuity Test
Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test (eye chart test) in subjects undergoing a full routine eye examination. Agreement will be determined by demonstrating that the LFR-260 is within 0.5D (+/-) in measuring sphere and cylinder results and within 10 degrees for axis results among subjects with low astigmatism and within 5 degrees among subjects with moderate to high astigmatism from the traditional phoropter.
Measured: Day 0
Precision of LFR260 in Repeated Testing
Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.
Measured: Day 0
Secondary outcomes (2)
Patient Satisfaction Survey
4-question survey (1=worst; 5=best) given to patients to determine satisfaction with LFR-260 device Quad view.
Q1: Was the LFR-260 device Quad view comfortable to use for your eye exam? (1=very uncomfortable - 5=very comfortable) Q2: Did the LFR-260 Quad view feel the same as the traditional phoropter when taking your eye exam? (1=LFR-260 definitely more uncomfortable - 5=LFR-260 definitely more comfortable) Q3: Did you prefer to read the eye chart using the LFR-260 device Quad view or traditional phoropter? (1=definitely prefer phoropter - 5=definitely prefer LFR-260) Q4: If taking an eye exam in the future, would you prefer your doctor use the LFR-260 Quad view or traditional phoropter? (1=definitely prefer phoropter - 5=definitely prefer LFR-260)
Measured: Day 0
Provider Satisfaction Survey
4-question survey (1=worst; 5=best) given to eye care provider to determine satisfaction with LFR-260 related to usability, convenience.
Q1: LFR-260 device performed as expected according to the Instructions for Use (IFU)? (1=definitely did not - 5=definitely) Q2: LFR-260 device was easy to use? (1=very difficult to use - 5=very easy to use) Q3: LFR-260 device was intuitive to operate? (1=definitely counterintuitive - 5=very intuitive) Q4: LFR-260 was more or less convenient to use than the phoropter? (1=definitely less convenient- 5=definitely more convenient)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start7 Jun 2022
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual AcuityStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigational product was compared to the traditional phoropter. Subjects were randomized to the order of testing.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolution Optiks Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259163
- Sponsor's protocol ID
- LFR-260-2021
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2022
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
- ClinicalTrials.gov ID
- NCT05259163
- Acronym / sponsor ID
- LFR-260-2021
- Conditions
- Visual Acuity, Astigmatism, Anisometropia
- Keywords
- Ocular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Evolution Optiks LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigational product was compared to the traditional phoropter. Subjects were randomized to the order of testing.
| Arm | Type | Receives |
|---|---|---|
| Group 1: LFR-260 first, then traditional phoropter | Experimental | Device: LFR-260 portable phoropter, Device: Traditional phoropter (SOC)The LFR-260 was administered first in this group, followed by the traditional phoropter. The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams. The traditional phoropter is intended to be used for distance vision testing in any environment. |
| Group II: Traditional Phoropter first, then LFR-260 | Active comparator | Device: LFR-260 portable phoropter, Device: Traditional phoropter (SOC)The traditional phoropter was administered first in this group, followed by the traditional phoropter. The traditional phoropter is intended to be used for distance vision testing in any environment. The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
- The participant is a male or female between the ages of 12 and 65 (inclusive).
- The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
- The participant is free of ocular and systemic abnormalities that might affect visual functions.
Key exclusion criteria (16 listed)
- The participant has diabetes mellitus (Type 1 or 2).
- The participant has an autoimmune condition.
- The participant is pregnant (self-reported).
- The participant has an active corneal or conjunctival infection.
- The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
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 |
|---|---|---|
| LFR-260 portable phoropterPortable unit to evaluate visual refractive state of the patient | Device | Group 1: LFR-260 first, then traditional phoropter, Group II: Traditional Phoropter first, then LFR-260 |
| Traditional phoropter (SOC)Standard unit for evaluating visual refractive state of the patient | Device | Group 1: LFR-260 first, then traditional phoropter, Group II: Traditional Phoropter first, then LFR-260 |
Primary outcome
Effectiveness of LFR260 on Visual Acuity Test
Time frame: Day 0
Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test (eye chart test) in subjects undergoing a full routine eye examination. Agreement will be determined by demonstrating that the LFR-260 is within 0.5D (+/-) in measuring sphere and cylinder results and within 10 degrees for axis results among subjects with low astigmatism and within 5 degrees among subjects with moderate to high astigmatism from the traditional phoropter.
Precision of LFR260 in Repeated Testing
Time frame: Day 0
Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.
2 secondary outcomes
Patient Satisfaction Survey
Time frame: Day 0
Provider Satisfaction Survey
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LFR-260 portable phoropter and Traditional phoropter (SOC) in people with Visual Acuity and Astigmatism, run by Evolution Optiks Limited at 2 sites 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 4 inclusion and 16 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness of LFR260 on Visual Acuity Test (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2024.