Clinical trial NCT05259163: LFR-260 vs Traditional Phoropter in Visual Acuity Testing
Official title: An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Astigmatism
Anisometropia
Keywords: Ocular
Lead sponsor: Evolution Optiks Limited
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 112
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigational product was compared to the traditional phoropter. Subjects were randomized to the order of testing.
Primary purpose: SCREENING

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
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:

1. The participant has diabetes mellitus (Type 1 or 2).
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.

Primary outcomes:
measure: Effectiveness of LFR260 on Visual Acuity Test
timeFrame: Day 0
measure: Precision of LFR260 in Repeated Testing
timeFrame: Day 0
Secondary outcomes:
measure: Patient Satisfaction Survey
timeFrame: Day 0
measure: Provider Satisfaction Survey
timeFrame: Day 0
Other outcomes:
Locations:
city: Worcester
country: United States
facility: MCPHS
state: Massachusetts
city: Oyster Bay
country: United States
facility: Gold Coast Optometric Vision
state: New York
Study officials:
References: