Anisometropia, Astigmatism, Visual Acuity
Conditions
Keywords
Ocular
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.
Interventions
DEVICELFR-260 portable phoropter
Portable unit to evaluate visual refractive state of the patient
DEVICETraditional phoropter (SOC)
Standard unit for evaluating visual refractive state of the patient
Sponsors
Evolution Optiks Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
The investigational product was compared to the traditional phoropter. Subjects were randomized to the order of testing.
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of LFR260 on Visual Acuity Test | Day 0 | 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. |
| Precision of LFR260 in Repeated Testing | Day 0 | Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Survey | Day 0 | 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) |
| Provider Satisfaction Survey | Day 0 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I: LFR-260 First, Then Traditional Phoropter The LFR-260 was administered first in this group, followed by the traditional phoropter. | 55 |
| Group II: Traditional Phoropter First, Then LFR-260 The traditional phoropter was administered first in this group, followed by the LFR-260. | 56 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Initial Testing - 1st Intervention | Investigator needed to continue adding cylinder beyond testing limit for the device. | 1 | 0 |
Baseline characteristics
| Characteristic | Group I: LFR-260 First, Then Traditional Phoropter | Group II: Traditional Phoropter First, Then LFR-260 | Total |
|---|---|---|---|
| Age, Customized Age Category <=21 years | 16 Participants | 10 Participants | 26 Participants |
| Age, Customized Age Category >21 years | 39 Participants | 46 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 47 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) White | 34 Participants | 39 Participants | 73 Participants |
| Region of Enrollment United States | 55 participants | 56 participants | 111 participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 74 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 |
| other Total, other adverse events | 0 / 55 | 0 / 56 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 |
Outcome results
Primary
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
Population: The total number of eyes analyzed was 222 for 111 study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I | Effectiveness of LFR260 on Visual Acuity Test | 76.6 percentage meeting criteria |
| Group II | Effectiveness of LFR260 on Visual Acuity Test | 76.6 percentage meeting criteria |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I | Precision of LFR260 in Repeated Testing | 93.8 percentage meeting criteria |
| Group II | Precision of LFR260 in Repeated Testing | 93.8 percentage meeting criteria |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I | Patient Satisfaction Survey | Question 1 | 3.7 score on a scale | Standard Deviation 0.93 |
| Group I | Patient Satisfaction Survey | Question 2 | 2.5 score on a scale | Standard Deviation 1.35 |
| Group I | Patient Satisfaction Survey | Question 3 | 2.1 score on a scale | Standard Deviation 1.51 |
| Group I | Patient Satisfaction Survey | Question 4 | 2.3 score on a scale | Standard Deviation 1.31 |
| Group II | Patient Satisfaction Survey | Question 4 | 2.3 score on a scale | Standard Deviation 1.33 |
| Group II | Patient Satisfaction Survey | Question 1 | 3.6 score on a scale | Standard Deviation 1.05 |
| Group II | Patient Satisfaction Survey | Question 3 | 2.1 score on a scale | Standard Deviation 1.41 |
| Group II | Patient Satisfaction Survey | Question 2 | 2.5 score on a scale | Standard Deviation 1.16 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I | Provider Satisfaction Survey | Question 3 | 3.1 score on a scale | Standard Deviation 1.1 |
| Group I | Provider Satisfaction Survey | Question 1 | 4.4 score on a scale | Standard Deviation 1.03 |
| Group I | Provider Satisfaction Survey | Question 4 | 2.3 score on a scale | Standard Deviation 0.75 |
| Group I | Provider Satisfaction Survey | Question 2 | 3.8 score on a scale | Standard Deviation 1.2 |
| Group II | Provider Satisfaction Survey | Question 4 | 2.2 score on a scale | Standard Deviation 0.78 |
| Group II | Provider Satisfaction Survey | Question 1 | 4.4 score on a scale | Standard Deviation 1.12 |
| Group II | Provider Satisfaction Survey | Question 3 | 3.0 score on a scale | Standard Deviation 1.04 |
| Group II | Provider Satisfaction Survey | Question 2 | 3.7 score on a scale | Standard Deviation 1.2 |