Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: LFR-260 first, then traditional phoropter | Experimental | 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. The traditional phoropter is intended to be used for distance vision testing in any environment. |
|
| Group II: Traditional Phoropter first, then LFR-260 | Active Comparator | The traditional phoropter was administered first in this group, followed by the traditional phoropter. The traditional phoropter is intended to be used for distance vision testing in any environment. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFR-260 portable phoropter | Device | Portable unit to evaluate visual refractive state of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Precision of LFR260 in Repeated Testing | Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCPHS | Worcester | Massachusetts | 01608 | United States | ||
| Gold Coast Optometric Vision |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Testing - 1st Intervention |
|
| ||||||||||||||||||
| 1 Hour (+/- 30 Min) - 2nd Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I: LFR-260 First, Then Traditional Phoropter | The LFR-260 was administered first in this group, followed by the traditional phoropter. |
| BG001 | Group II: Traditional Phoropter First, Then LFR-260 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The total number of eyes analyzed was 222 for 111 study participants. | Posted | Number | percentage meeting criteria | Day 0 | eyes | eyes |
|
Adverse events were collected for the study period for each patient, which included a single visit where all study data was collected, up to 4 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LFR-260 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raul Mihali | Evolution Optiks | 2039815480 | raul.mihali@evolutionoptiks.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2022 | Jul 31, 2024 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D015858 | Anisometropia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
The investigational product was compared to the traditional phoropter. Subjects were randomized to the order of testing.
Not provided
Not provided
Not provided
Not provided
| Traditional phoropter (SOC) | Device | Standard unit for evaluating visual refractive state of the patient |
|
| 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) | Day 0 |
| Oyster Bay |
| New York |
| 11771 |
| United States |
| NOT COMPLETED |
|
The traditional phoropter was administered first in this group, followed by the LFR-260.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Group II |
The traditional phoropter was administered first in this group, followed by the LFR-260. |
|
|
| Primary | Precision of LFR260 in Repeated Testing | Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260. | Posted | Number | 90% Confidence Interval | percentage meeting criteria | Day 0 | eyes | eyes |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Traditional Phoropter | 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 | 0 | 56 | 0 | 56 | 0 | 56 |
Not provided
Not provided
| Question 3 |
|
| Question 4 |
|
| Question 3 |
|
| Question 4 |
|