LFR-260 vs Traditional Phoropter in Visual Acuity Testing (NCT05259163) | Clinical Trial Compass
CompletedNot Applicable
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
United States112 participantsStarted 2022-06-07
Plain-language 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.
Who can participate
Age range12 Years – 65 Years
SexALL
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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).