N/A
N=112
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
Visual Acuity · Astigmatism · Anisometropia
Bottom Line
View on ClinicalTrials.gov: NCT05259163 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Effectiveness of LFR260 on Visual Acuity Test — 76.6; 76.6 percentage meeting criteria
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LFR-260 portable phoropter (Device); Traditional phoropter (SOC) (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Evolution Optiks Limited
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of LFR260 on Visual Acuity Test |
76.6; 76.6 | — |
| PRIMARY Precision of LFR260 in Repeated Testing |
93.8; 93.8 | — |
| SECONDARY Patient Satisfaction Survey |
3.7; 3.6; 2.5; 2.5; 2.1; 2.1 | — |
| SECONDARY Provider Satisfaction Survey |
4.4; 4.4; 3.8; 3.7; 3.1; 3.0 | — |
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
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT05259163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.