(233 days)
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No
The description mentions "algorithms that apply modifications to the videos" but does not provide any details suggesting these algorithms are based on AI or ML. There is no mention of training data, test data, or typical AI/ML performance metrics.
Yes
Luminopia One is explicitly described as a "software-only digital therapeutic" designed to improve visual acuity in amblyopia patients aged 4-7. Its mechanism involves modifying videos to rebalance visual input and encourage the use of the weaker eye, which directly aims to treat the condition.
No
The device description indicates that Luminopia One is a therapeutic device designed to improve visual acuity in amblyopia patients by modifying videos presented to each eye. It does not mention any function for diagnosing amblyopia or any other condition.
Yes
The device is explicitly described as a "software-only digital therapeutic" and "Software as a Medical Device (SaMD)". While it requires a commercially available Head-Mounted Display (HMD) for use, the device itself is the software application that runs on the HMD and the associated Patient Portal. The HMD is treated as compatible hardware, not part of the medical device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of Luminopia One clearly states it is a software-only digital therapeutic used with a head-mounted display to treat amblyopia by modifying visual input to the eyes. It does not involve the analysis of any biological samples (blood, urine, tissue, etc.).
- The intended use is for treatment, not diagnosis. The primary indication is "improvement in visual acuity in amblyopia patients," which is a therapeutic goal, not a diagnostic one.
- The device description focuses on how it modifies visual input. The description details how the software alters videos presented to each eye to encourage weaker eye usage, which is a treatment mechanism.
Therefore, Luminopia One falls under the category of a therapeutic device, specifically a Software as a Medical Device (SaMD), rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.
Product codes
QQU
Device Description
Luminopia One is a Software as a Medical Device (SaMD) intended to improve visual acuity in pediatric patients with amblyopia (also known as lazy eye). The device is indicated for improvement in visual acuity at 12 weeks of use in amblyopia patients aged 4-7. The software is designed to be used with commercially available head-mounted displays (HMDs) (Figure 1) and is intended for at-home use. In this submission, the Samsung Gear HMD has been validated to be compatible with Luminopia One. The Patient should wear their refractive correction, such as glasses, under the HMD during treatment.
The software allows patients to select videos to watch (Figure 2).
Treatment is provided through algorithms that apply modifications to the videos to encourage use of the amblyopic eve. The video presented to the fellow eye (the stronger eye) is different from the video presented to the amblyopic eve (weaker eye) (Figure 3). When a video begins in the software application, the patient will see a modified version of the original video through each eye. This is intended to rebalance the visual input to the eyes and encourage weaker eye usage. The treatment regimen is the following: the patient watches the video 1 hour per day, 6 days per week for a total of 12 weeks.
Luminopia One also includes a Patient Portal. The Patient/Caregiver will also have access to an online Patient Portal where they can review the Patient's adherence and select their favorite videos to watch in the HMD. The Patient Portal enables the Caregiver to review the patient's progress and treatment plan and curate content for the patient to watch. The Patient Portal is designed to be used by the Caregiver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
age 4-7 years
Intended User / Care Setting
Prescription use only, in an at-home environment, under the direct supervision of a trained eye-care professional (ophthalmologist or optometrist). Patient/Caregiver may use a Patient Portal.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A randomized controlled clinical study was conducted that evaluated 117 subjects age 4-7 years. treated for 12 weeks with Luminopia One (1 hour daily, 6 days a week, for 12 weeks) along with fulltime refractive correction, as compared to control treatment with refractive correction alone. with final assessment at the 12-week visit. Interim analysis was conducted per protocol after 75% of subjects completed the 12-week follow up visit. At that time there were 105 subjects (51 Luminopia One therapeutic group, 54 control group). The study was stopped early for success, per protocol, when 75% of subjects completed the 12-week visit, since primary effectiveness and safety endpoints were achieved at interim analysis. Final analysis included 117 subjects (58 Luminopia One therapeutic group, 59 control group), reported as descriptive outcome information in the device labeling.
The mean age of all study participants was 6.0±1.0 years (n = 117). Among them, 56.4% (66/117) were male and 43.6% (51/117) were female. The mean age for the Luminopia One treatment group was 6.2 ± 0.9 (n = 58) years. In the treatment group, 60.3% (35/58) of the subjects were male and 39.7% (23/58) were female. The mean age for the control group (refractive correction only) was 5.9 ± 1.1 (n = 59). In the control group, 52.5% (31/59) of the subjects were male and 47.5% (28/59) were female.
In terms of ethnicity, 22.4% (13/58) of the subjects in the treatment group were Hispanic or Latino and 77.6% (45/58) were not Hispanic or Latino. In the control group, 10.2% (6/59) of the subjects were Hispanic or Latino and 89.8% (53/59) were not Hispanic or Latino.
The percentages of subjects whose right eye is amblyopic are 45.6% (26/57) for the treatment group and 47.5% (28/59) for the control group. The percentages of subjects whose left eye is amblyopic are 54.4% (31/57) for the treatment group and 52.5% (31/59) for the control group.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Randomized controlled clinical study.
Sample Size:
Interim analysis (N=105, n=84): 51 Luminopia One therapeutic group subjects, 54 control group subjects.
Final analysis (N=117): 58 Luminopia One therapeutic group subjects, 59 control group subjects.
Key Results:
Primary Effectiveness Endpoint: Mean improvements from baseline in amblyopic eye's best corrected visual acuity (BCVA) after 12-week treatment show statistically significant difference between the treatment and control groups; superiority of the treatment was demonstrated and the endpoint was met.
- Interim analysis (N=105, n=84): Mean change -0.180 (SD=0.15) logMAR in the therapeutic group, -0.080 (SD=0.14) logMAR in the control group. Average difference between groups -0.10 logMAR, greater improvement in the treatment group compared to control group (p=0.0012). Mean BCVA improvement in amblyopic eye was 1.8 lines in the treatment group vs. 0.8 lines in control group. Point estimate difference in improvement is 1.0 line (90% CI: 0.5-1.5 lines).
- Final analysis (N=117, n=88): Mean change was -0.181 logMAR (SD=0.15) in the therapeutic group and -0.085 logMAR (SD=0.14) in the control group. The average difference between groups was -0.096 logMAR, larger improvement in Luminopia One group (p = 0.0011), consistent with interim analysis results. BCVA improved by 1.8 lines in the treatment group vs. 0.85 lines in the control group. Point estimate of difference between groups is 0.96 line (90% CI: 0.45-1.47 lines).
Secondary Effectiveness Endpoint: Amblyopic eye BCVA improvement 2 or more lines from baseline after 12 weeks.
- 62% of Luminopia subjects (95% CI: 46-76%) vs. 33% of control subjects (95% CI: 20-48%). This analysis was pre-specified as descriptive analysis only.
Exploratory Analyses:
- Stereoacuity (depth perception) did not show meaningful difference between groups.
- Mean Treatment Adherence with Luminopia One device was 75.7% from baseline to 12 weeks.
Co-Primary Safety Endpoints:
- Adverse Events (AEs): Moderate probability of device-related adverse events. Clinically meaningful higher rate in the Luminopia One group than in the control group.
- Overall AE rate: 25% of Luminopia One group (14 subjects, 25 events) vs. 13.6% of control group (all mild except one AE "worsening night terrors" severe).
- Headaches: 14.3% Luminopia One group (8 subjects, 9 events) vs. 1.7% control group (1 subject, 1 event) - All intermittent and mild, no Rx treatments, no OTC medication, all resolved without sequelae.
- Eye strain: 3.6% (2 subjects, 3 events) Luminopia One group vs. 0% control group.
- "Other" includes "increased frequency of night terrors*, facial redness, eyelidtwich, dizziness, parent-reported intermittent eve turning when tired": 7.1% (4 subjects, 5 events) Luminopia One group vs. 0% control group.
- Mean change non-amblyopic (fellow) eye BCVA from baseline: Luminopia One treatment group demonstrated non-inferiority to control group.
- Interim analysis (N=105, n=84): Mean change in fellow eye BCVA was -0.03 logMAR (SD=0.08) in therapeutic group and -0.02 logMAR (SD=0.06) in control group, indicating both groups had improvement in fellow eye vision. Difference between groups was -0.02 logMAR with upper 95% confidence limit of 0.010 and p-value
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR LUMINOPIA ONE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Digital therapy device for amblyopia. A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.
NEW REGULATION NUMBER: 21 CFR 886.5500
CLASSIFICATION: Class II
PRODUCT CODE: QQU
BACKGROUND
DEVICE NAME: Luminopia One
SUBMISSION NUMBER: DEN210005
DATE DE NOVO RECEIVED: March 1, 2021
SPONSOR INFORMATION:
Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge, Massachusetts 02139
INDICATIONS FOR USE
Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.
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LIMITATIONS
Luminopia One is intended to be used as an adjunct to fulltime refractive correction such as glasses, which should also be worn under the Head-Mounted Display (HMD) headset during Luminopia One therapy.
Federal law restricts this digital therapeutic to sale by or on the order of an ophthalmologist or optometrist.
As outlined in the Indications for Use, Luminopia One is a prescription device for children ages 4 to 7 to improve visual acuity for certain medical conditions and should be used under the direct supervision of a trained eye-care professional. The device is indicated for use with compatible, commercially available head-mounted displays (HMDs). Currently, the Samsung Gear HMD is the only compatible HMD. For all other uses of such HMD, users should follow the user manual and instructional information for the specific HMD used with Luminopia One, including the age range specified by the HMD manufacturer.
Patients should only use HMDs that are compatible with Luminopia One, as described in the "Directions for Use" labeling. The Luminopia One device is currently authorized to be used with the following commercially available HMDs that have been validated as compatible with the software application:
- Samsung Gear HMD .
Patients with an interpupillary distance of less than 52 mm should not use the Luminopia One device. The Luminopia One device has not been studied on patients with interpupillary distances of less than 52 mm. Attempting to use the Luminopia One device on these patients may result in decreased effectiveness of treatment and increased risk of adverse symptoms.
Because the Luminopia One clinical study did not follow patients after 12 weeks of use, limitations include:
- Safety and effectiveness of Luminopia One therapy beyond 12 weeks is unknown ● and was not evaluated in the clinical study.
- The durability of benefit from the Luminopia One device after treatment cessation is unknown (i.e., unknown whether visual acuity improvement at 12 weeks will be maintained or regress over time).
- . The long-term effects of Head-Mounted Display (HMD) use in patients 4-7 years of age are unknown.
In the 12-week clinical study, use of Luminopia One did not demonstrate a clinically meaningful improvement in stereoacuity (depth perception).
Please refer to Luminopia One "Directions for Use" for a complete list of WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS, as well as a description of CLINICAL STUDY OUTCOMES.
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DEVICE DESCRIPTION
Luminopia One is a Software as a Medical Device (SaMD) intended to improve visual acuity in pediatric patients with amblyopia (also known as lazy eye). The device is indicated for improvement in visual acuity at 12 weeks of use in amblyopia patients aged 4-7. The software is designed to be used with commercially available head-mounted displays (HMDs) (Figure 1) and is intended for at-home use. In this submission, the Samsung Gear HMD has been validated to be compatible with Luminopia One. The Patient should wear their refractive correction, such as glasses, under the HMD during treatment.
Image /page/2/Figure/2 description: The image shows two diagrams of a person wearing a virtual reality headset. The diagram on the left shows the person facing forward, with the headset covering their eyes. A dashed line runs down the center of the person's face. The diagram on the right shows the person in profile, with the headset covering their eyes and a dashed line indicating the eye level.
Figure 1. Luminopia One is used with compatible head-mounted displays.
Image /page/2/Figure/4 description: The image shows a screen display of movies and TV shows. The top row displays movie content thumbnails, including titles such as "Deepsea," "Sandman," and "Polar Explorer." Below the movies are TV shows, displayed as circular thumbnails with various cartoon characters. The bottom of the screen shows logos for Netflix and Molang.
The software allows patients to select videos to watch (Figure 2).
Figure 2. Selection menus for TV shows and movies
Treatment is provided through algorithms that apply modifications to the videos to encourage use of the amblyopic eve. The video presented to the fellow eye (the stronger eye) is different from the video presented to the amblyopic eve (weaker eye) (Figure 3). When a video begins in the software application, the patient will see a modified version of the original video through
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each eye. This is intended to rebalance the visual input to the eyes and encourage weaker eye usage. The treatment regimen is the following: the patient watches the video 1 hour per day, 6 days per week for a total of 12 weeks.
Image /page/3/Picture/1 description: The image shows a side-by-side comparison of two video screens, labeled "WEAKER EYE" and "STRONGER EYE." Both screens display video content with a progress bar and playback controls at the bottom. The progress bar indicates that there are 23 minutes remaining in both videos. The video on the left is labeled "WEAKER EYE" and the video on the right is labeled "STRONGER EYE."
Figure 3. Left: Videos presented to the amblyopic eye (weaker eye); Right: video presented to the fellow eye (stronger eye).
Luminopia One also includes a Patient Portal. The Patient/Caregiver will also have access to an online Patient Portal where they can review the Patient's adherence and select their favorite videos to watch in the HMD. The Patient Portal enables the Caregiver to review the patient's progress and treatment plan
and curate content for the patient to watch. The Patient Portal is designed to be used by the Caregiver.
SUMMARY OF NONCLINICAL/BENCH STUDIES
| Test | Purpose | Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| HMD | ||||
| Temperature | ||||
| measurements | To prevent thermal | |||
| injury and/or adverse | ||||
| events | Human subject wore the HMD | |||
| with multiple temperature probes | ||||
| placed at different locations of | ||||
| HMD | IEC 60601-1; | |||
| Temperature does not | ||||
| exceed 41°C on the | ||||
| human contacting | ||||
| parts of the HMD | Passed | |||
| Luminance | ||||
| and its | ||||
| uniformity | To ensure luminance is | |||
| sufficiently high and | ||||
| uniform across the | ||||
| visual display | IEC63145-20-10: Eyewear display |
- Part 20-10: Fundamental
measurement methods - Optical
properties. Luminance
measurements at 9 or more
locations in the field of view
(FOV) using a uniform white
testing pattern to determine the
luminance and uniformity across
the FOV. | Minimum luminance
should not be lower
than 48 candela per
square meter (Cd/m2).
The percent deviation
from the average
luminance at each
location should not be
higher than 50% | Passed |
| Contrast
measurements | To ensure the visual
display has sufficient | IEC63145-20-10: Eyewear display - Part 20-10: Fundamental | At least 90% at each
location | Passed |
PERFORMANCE TESTING - BENCH
4
| | contrast to display
quality video and video
modifications
implemented by
software | measurement methods - Optical
properties. Contrast measurements
at 9 or more locations in the field
of view using a test pattern, such as
a grille pattern. Contrast can be
calculated using the Michelson
contrast equation | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| HMD
resolution | To ensure the quality of
the video | Calculate the horizontal and
vertical pixels per degree by
measuring horizontal and vertical
field of view and the number of
pixels in the test image. | At least 14 pixels per
degree | Passed |
| Crosstalk
testing | To ensure that light
from one eyepiece of
the HMD cannot be
seen by the other eye to
prevent interference
with the treatment | Measure luminance with the
following combinations: (1) Both
eyepieces have a uniform black
test pattern (off); (2) Eyepiece 1
has a uniform white test pattern
(on) and eyepiece 2 is off; (3)
Eyepiece 1 is off and eyepiece 2 is
on.
See Information Display
Measurements Standard 1.03
(IDMSv1.03) as reference. | Light entered from one
eyepiece to another is
not significantly
higher than
background levels. | Passed |
| Labeling
comprehension
testing | To ensure that the
Direction of Use (DFU)
conveys clear
instructions to the
parent/caregiver | DFU comprehension testing and
device use testing: (1) caregiver
and child pairs are tested through
the knowledge tasks to
demonstrate their understanding of
the DFU; (2) caregiver and child
pairs are tested through the
performance tasks to demonstrate
that they can use device
successfully. | Testing demonstrated
that caregivers and
patients understood
the directions of use
and could use the
device successfully.
There were minimal
use errors in the use of
the device. | Passed |
SOFTWARE
Luminopia One is a Software as a Medical Device (SaMD). It was reviewed according to the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. The software was found to have a MODERATE level of concern because a failure of the device may result in a minor injury to a patient prior to risk mitigation. FDA reviewed the software documentation provided in support of Luminopia One and found it acceptable.
Software controls have been implemented in Luminopia One to minimize overuse of the device. The user will be presented a pop-up warning when the daily use of the device exceeds the prescribed length of time. A software control will implement a lock-out at the end of entire prescribed treatment regimen.
SUMMARY OF CLINICAL INFORMATION
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A randomized controlled clinical study was conducted that evaluated 117 subjects age 4-7 years. treated for 12 weeks with Luminopia One (1 hour daily, 6 days a week, for 12 weeks) along with fulltime refractive correction, as compared to control treatment with refractive correction alone. with final assessment at the 12-week visit. Amblyopia is clinically defined as reduction of visual acuity (VA) that cannot be attributed to ocular or visual system abnormality or refractive error. The American Academy of Ophthalmology (AAO) considers amblyopia as an interocular difference of 2 lines or more or VA worse than or equal to 20/30 with best optical correction '. The Luminopia One clinical study inclusion criterion for VA met the AAO definition. Interim analysis was conducted per protocol after 75% of subjects completed the 12-week follow up visit. At that time there were 105 subjects (51 Luminopia One therapeutic group, 54 control group). The study was stopped early for success, per protocol, when 75% of subjects completed the 12-week visit, since primary effectiveness and safety endpoints were achieved at interim analysis. Final analysis included 117 subjects (58 Luminopia One therapeutic group, 59 control group), reported as descriptive outcome information in the device labeling.
The mean age of all study participants was 6.0±1.0 years (n = 117). Among them, 56.4% (66/117) were male and 43.6% (51/117) were female. The mean age for the Luminopia One treatment group was 6.2 ± 0.9 (n = 58) years. In the treatment group, 60.3% (35/58) of the subjects were male and 39.7% (23/58) were female. The mean age for the control group (refractive correction only) was 5.9 ± 1.1 (n = 59). In the control group, 52.5% (31/59) of the subjects were male and 47.5% (28/59) were female.
In terms of ethnicity, 22.4% (13/58) of the subjects in the treatment group were Hispanic or Latino and 77.6% (45/58) were not Hispanic or Latino. In the control group, 10.2% (6/59) of the subjects were Hispanic or Latino and 89.8% (53/59) were not Hispanic or Latino.
The percentages of subjects whose right eye is amblyopic are 45.6% (26/57) for the treatment group and 47.5% (28/59) for the control group. The percentages of subjects whose left eye is amblyopic are 54.4% (31/57) for the treatment group and 52.5% (31/59) for the control group.
- Evidence of clinical benefit for Luminopia One as used in the clinical study with refractive correction:
o Primary Effectiveness Endpoint: Mean improvements from baseline in amblyopic eye's best corrected visual acuity (BCVA) after 12-week treatment show statistically significant difference between the treatment and control groups; superiority of the treatment was demonstrated and the endpoint was met:
· Interim analysis (N=105. n=84): Mean change -0.180 (SD=0.15) logMAR in the therapeutic group, -0.080 (SD=0.14) logMAR in the control group (see Table 1 below). Average difference between groups -0.10 logMAR, greater improvement in the treatment group compared to control group (p=0.0012). Mean BCVA improvement in amblyopic eye was 1.8 lines in the treatment group vs. 0.8 lines
1 https://www.aao.org/disease-review/amblyopia-types-diagnosis-treatment-new-perspectiv
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| Table 1: Amblyopic Eye BCVA1 - Intention-to-Treat (ITT) Population at Interim
| Analysis | Results | |||||
|---|---|---|---|---|---|---|
| Treatment | ||||||
| Group | ||||||
| N=51 | Control Group | |||||
| N=54 | Difference in | |||||
| Change in | ||||||
| BCVA2 | ||||||
| (90% CI) | P-value3 | Stage 1 | ||||
| Alpha | ||||||
| Level | Decision | |||||
| Improvement from | ||||||
| Baseline at 12 | ||||||
| Weeks (lines)4 | 1.8 ± 1.5 (41) | |||||
| 2.0 (-2.0, 6.0) | ||||||
| [1.3, 2.3] | 0.8 ± 1.4 (43) | |||||
| 1.0 (-2.0, 4.0) | ||||||
| [0.4, 1.3] | 1.0 | |||||
| (0.5, 1.5) | 0.0012 | 0.0176 | Reject H0 | |||
| Change from | ||||||
| Baseline at 12 | ||||||
| Weeks (logMAR) | -0.18 ± 0.15 (41) | |||||
| -0.20 (-0.60, 0.20) | ||||||
| [-0.23, -0.13] | -0.08 ± 0.14 (43) | |||||
| -0.10 (-0.40, 0.20) | ||||||
| [-0.13, -0.04] | ||||||
| Baseline (logMAR) | 0.54 ± 0.21 (41) | |||||
| 0.50 (0.30, 1.00) | 0.50 ± 0.19 (43) | |||||
| 0.40 (0.30, 1.00) | ||||||
| 12 Weeks (logMAR) | 0.36 ± 0.23 (41) | |||||
| 0.30 (0.00, 1.10) | 0.42 ± 0.21 (43) | |||||
| 0.40 (0.00, 1.00) | ||||||
| 1Based on participants with available data at baseline and in-window 12- | ||||||
| week visits. Data presented as mean ± standard deviation (N) median (min, max). Change from baseline also includes [95% CI]. | ||||||
| 2Difference between groups (treatment - control) and 90% confidence interval are based on the coefficient associated | ||||||
| treatment group from an ANOVA model. Positive difference between groups represents larger improvement in the treatment group. |
in control group. Point estimate difference in improvement is 1.0 line (90% CI: 0.5-1.5 lines).
P value is based on a one-sided F-test for the coefficient associated with treatment group from an ANOVA model
"Original visual acuity measurements captured using inprovement from baseline corresponds to a change of -0.10 lgMAR
The bar chart below (Figure 4) shows the mean BCVA improvements in the treatment group vs. the control group after 4, 8 and 12 weeks of treatment.
Image /page/6/Figure/5 description: The image is a bar graph comparing the improvement in BCVA (Lines) between a treatment group and a control group at different follow-up visits (4, 8, and 12 weeks). The y-axis represents the improvement in BCVA, ranging from 0 to 2.5 lines. At each follow-up visit, the treatment group (green bars) shows a greater improvement in BCVA compared to the control group (blue bars), with statistically significant differences indicated by asterisks.
Figure 4. Improvement in amblyopic eye BCVA from baseline - ITT population at interim analysis at 4, 8, and 12 weeks (error bars denote ± SEM, * denotes p 0% adherence of device use are in the treatment arm,
otherwise control; there are no control subjects treated with the device. | | |
| ³Other AEs in treatment group include: Eye Twitch, Facial Redness, Increase in Frequency of Night Terrors, Dizziness,
Parent reported intermitted eye turning when tired | | |
o Mean change non-amblyopic (fellow) eye BCVA from baseline, Luminopia One treatment group demonstrated non-inferiority to control group:
· Interim analysis (N=105, n=84): Mean change in fellow eye BCVA was -0.03 logMAR (SD=0.08) in therapeutic group and -0.02 logMAR (SD=0.06) in control group, indicating both groups had improvement in fellow eye vision. Difference
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between groups was -0.02 logMAR with upper 95% confidence limit of 0.010 and p-value