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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
112
Portable unit to evaluate visual refractive state of the patient
Standard unit for evaluating visual refractive state of the patient
MCPHS
Worcester, Massachusetts, United States
Gold Coast Optometric Vision
Oyster Bay, New York, United States
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.
Time frame: Day 0
Precision of LFR260 in Repeated Testing
Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.
Time frame: Day 0
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)
Time frame: 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)
Time frame: Day 0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.