LFR-260 vs Traditional Phoropter in Visual Acuity Testing
NCT ID: NCT05259163
Last Updated: 2024-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2022-06-07
2023-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Group 1: LFR-260 first, then traditional phoropter
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.
LFR-260 portable phoropter
Portable unit to evaluate visual refractive state of the patient
Traditional phoropter (SOC)
Standard unit for evaluating visual refractive state of the patient
Group II: Traditional Phoropter first, then LFR-260
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.
LFR-260 portable phoropter
Portable unit to evaluate visual refractive state of the patient
Traditional phoropter (SOC)
Standard unit for evaluating visual refractive state of the patient
Interventions
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LFR-260 portable phoropter
Portable unit to evaluate visual refractive state of the patient
Traditional phoropter (SOC)
Standard unit for evaluating visual refractive state of the patient
Eligibility Criteria
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Inclusion Criteria
2. The participant is a male or female between the ages of 12 and 65 (inclusive).
3. The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
4. The participant is free of ocular and systemic abnormalities that might affect visual functions.
Exclusion Criteria
2. The participant has an autoimmune condition.
3. The participant is pregnant (self-reported).
4. The participant has an active corneal or conjunctival infection.
5. The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
6. The participant has diabetic retinopathy.
7. The participant has glaucoma or ocular hypertension.
8. The participant has macular degeneration.
9. The participant has had a previous ocular surgery.
10. The participant has ocular and systemic diseases or abnormalities that might affect visual functions.
11. The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.
12. The participant has a history of AMD (age macular degeneration).
13. 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.
14. The participant will not be able to complete questionnaires.
15. The participant is currently in an investigational study for a similar purpose.
16. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
12 Years
65 Years
ALL
Yes
Sponsors
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Evolution Optiks Limited
INDUSTRY
Responsible Party
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Locations
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MCPHS
Worcester, Massachusetts, United States
Gold Coast Optometric Vision
Oyster Bay, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LFR-260-2021
Identifier Type: -
Identifier Source: org_study_id
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