(233 days)
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.
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) 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. 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). 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.
Here's a detailed breakdown of the acceptance criteria and the study proving the Luminopia One device meets them, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
Bench/Non-Clinical Performance Testing
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| HMD Temperature measurements | IEC 60601-1; Temperature does not exceed 41°C on the human contacting parts of the HMD | Passed |
| Luminance and its uniformity | 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 | At least 90% at each location | Passed |
| HMD resolution | At least 14 pixels per degree | Passed |
| Crosstalk testing | Light entered from one eyepiece to another is not significantly higher than background levels. | Passed |
| Labeling comprehension testing | 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 |
Clinical Performance Testing (Effectiveness)
| Performance Metric | Acceptance Criteria (Implicit from study design as superiority) | Reported Device Performance (Relative to Control Group) |
|---|---|---|
| Primary Effectiveness Endpoint: Mean improvement from baseline in amblyopic eye's Best Corrected Visual Acuity (BCVA) at 12 weeks | Statistically significant difference between treatment and control groups, demonstrating superiority of Luminopia One. | Treatment group: -0.180 logMAR (1.8 lines) improvement. Control group: -0.080 logMAR (0.8 lines) improvement. Average difference: 1.0 line improvement (90% CI: 0.5, 1.5 lines). p=0.0012 (Interim Analysis). Final analysis (N=117): Difference 0.96 lines (90% CI: 0.45-1.47 lines), p=0.0011. |
| Secondary Effectiveness Endpoint: Percentage of subjects with ≥ 2 lines BCVA improvement at 12 weeks | Not explicitly stated as an acceptance criterion, but implicitly that a meaningful percentage in the treatment group achieves this. | 61.9% of Luminopia One subjects (95% CI: 45.6-76.4%) vs. 32.6% of control subjects (95% CI: 19.5-48.0%) at final analysis. |
Clinical Performance Testing (Safety)
| Performance Metric | Acceptance Criteria (Implicit: not cause unacceptable harm) | Reported Device Performance (Relative to Control Group) |
|---|---|---|
| Co-Primary Safety Endpoint: Adverse Events (AEs) | Moderate probability of device-related adverse events. | Overall AE rate: 25% (Luminopia One) vs. 13.6% (control). Higher rates in Luminopia One for headaches (14.3% vs. 1.7%), eye strain (3.6% vs. 0%), and "other" (7.1% vs. 0%). All non-serious except one severe case of "worsening night terrors" in the treatment group, however, this was a pre-existing condition and led to child's withdraw from study. |
| Co-Primary Safety Endpoint: Mean change non-amblyopic (fellow) eye BCVA from baseline | Non-inferiority to control group. | Interim Analysis: Difference -0.02 logMAR, upper 95% CL 0.010, p |
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