Trial Outcomes & Findings for LFR-260 vs Traditional Phoropter in Visual Acuity Testing (NCT NCT05259163)
NCT ID: NCT05259163
Last Updated: 2024-09-25
Results Overview
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.
COMPLETED
NA
112 participants
Day 0
2024-09-25
Participant Flow
Participant milestones
| Measure |
LFR-260 First, Then Traditional Phoropter
The LFR-260 was administered first in this group, followed by the traditional phoropter. The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams.
LFR-260 portable phoropter: Portable unit to evaluate visual refractive state of the patient
|
Traditional Phoropter First, Then LFR-260
The traditional phoropter was administered first in this group, followed by the LFR-260. The traditional phoropter is intended to be used for distance vision testing in any environment. The traditional phoropter is an application-controlled instrument providing the same subjective refraction capabilities for distance vision testing as the standard of care eye examination including sphere, cylinder, and axis. Traditional phoropter (Standard of Care): Standard unit for evaluating visual refractive state of the patient
|
|---|---|---|
|
Initial Testing - 1st Intervention
STARTED
|
56
|
56
|
|
Initial Testing - 1st Intervention
COMPLETED
|
55
|
56
|
|
Initial Testing - 1st Intervention
NOT COMPLETED
|
1
|
0
|
|
1 Hour (+/- 30 Min) - 2nd Intervention
STARTED
|
55
|
56
|
|
1 Hour (+/- 30 Min) - 2nd Intervention
COMPLETED
|
55
|
56
|
|
1 Hour (+/- 30 Min) - 2nd Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
LFR-260 First, Then Traditional Phoropter
The LFR-260 was administered first in this group, followed by the traditional phoropter. The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams.
LFR-260 portable phoropter: Portable unit to evaluate visual refractive state of the patient
|
Traditional Phoropter First, Then LFR-260
The traditional phoropter was administered first in this group, followed by the LFR-260. The traditional phoropter is intended to be used for distance vision testing in any environment. The traditional phoropter is an application-controlled instrument providing the same subjective refraction capabilities for distance vision testing as the standard of care eye examination including sphere, cylinder, and axis. Traditional phoropter (Standard of Care): Standard unit for evaluating visual refractive state of the patient
|
|---|---|---|
|
Initial Testing - 1st Intervention
Investigator needed to continue adding cylinder beyond testing limit for the device.
|
1
|
0
|
Baseline Characteristics
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
Baseline characteristics by cohort
| Measure |
Group I: LFR-260 First, Then Traditional Phoropter
n=55 Participants
The LFR-260 was administered first in this group, followed by the traditional phoropter.
|
Group II: Traditional Phoropter First, Then LFR-260
n=56 Participants
The traditional phoropter was administered first in this group, followed by the LFR-260.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Category · <=21 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Customized
Age Category · >21 years
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
56 participants
n=7 Participants
|
111 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: The total number of eyes analyzed was 222 for 111 study participants.
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.
Outcome measures
| Measure |
Group I
n=110 eyes
The LFR-260 was administered first in this group, followed by the traditional phoropter.
|
Group II
n=112 eyes
The traditional phoropter was administered first in this group, followed by the LFR-260.
|
|---|---|---|
|
Effectiveness of LFR260 on Visual Acuity Test
|
76.6 percentage meeting criteria
|
76.6 percentage meeting criteria
|
PRIMARY outcome
Timeframe: Day 0Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.
Outcome measures
| Measure |
Group I
n=110 eyes
The LFR-260 was administered first in this group, followed by the traditional phoropter.
|
Group II
n=112 eyes
The traditional phoropter was administered first in this group, followed by the LFR-260.
|
|---|---|---|
|
Precision of LFR260 in Repeated Testing
|
93.8 percentage meeting criteria
Interval 89.3 to 96.7
|
93.8 percentage meeting criteria
Interval 89.3 to 96.7
|
SECONDARY outcome
Timeframe: Day 04-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)
Outcome measures
| Measure |
Group I
n=55 Participants
The LFR-260 was administered first in this group, followed by the traditional phoropter.
|
Group II
n=56 Participants
The traditional phoropter was administered first in this group, followed by the LFR-260.
|
|---|---|---|
|
Patient Satisfaction Survey
Question 2
|
2.5 score on a scale
Standard Deviation 1.35
|
2.5 score on a scale
Standard Deviation 1.16
|
|
Patient Satisfaction Survey
Question 3
|
2.1 score on a scale
Standard Deviation 1.51
|
2.1 score on a scale
Standard Deviation 1.41
|
|
Patient Satisfaction Survey
Question 4
|
2.3 score on a scale
Standard Deviation 1.31
|
2.3 score on a scale
Standard Deviation 1.33
|
|
Patient Satisfaction Survey
Question 1
|
3.7 score on a scale
Standard Deviation .93
|
3.6 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Day 04-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)
Outcome measures
| Measure |
Group I
n=55 Participants
The LFR-260 was administered first in this group, followed by the traditional phoropter.
|
Group II
n=56 Participants
The traditional phoropter was administered first in this group, followed by the LFR-260.
|
|---|---|---|
|
Provider Satisfaction Survey
Question 1
|
4.4 score on a scale
Standard Deviation 1.03
|
4.4 score on a scale
Standard Deviation 1.12
|
|
Provider Satisfaction Survey
Question 2
|
3.8 score on a scale
Standard Deviation 1.20
|
3.7 score on a scale
Standard Deviation 1.2
|
|
Provider Satisfaction Survey
Question 3
|
3.1 score on a scale
Standard Deviation 1.10
|
3.0 score on a scale
Standard Deviation 1.04
|
|
Provider Satisfaction Survey
Question 4
|
2.3 score on a scale
Standard Deviation .75
|
2.2 score on a scale
Standard Deviation .78
|
Adverse Events
LFR-260
Traditional Phoropter
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place