Efficacy and Safety Demonstrated Across 3 Trials at 23 Sites in Over 200 Patients
Strong Efficacy In Randomized Controlled Phase 3 Trial
Similar Benefit Seen in Patients With or Without Prior Treatment
84% of Luminopia patients received treatment beyond glasses prior to the trial
94% of prior treated patients had been patched
|>3 Months||88% (n=30)||72% (n=23)|
|>6 Months||56% (n=19)||47% (n=15)|
Patients with Mild Strabismus Gained Similar Benefit
Patients with <= 5 PD of heterotropia at distance were enrolled
High rate of strong responders
High Adherence and Preferred by Parents
1 hr/day, 6 days/week
No serious adverse events were reported.
|Treatment Group2 (N=56)||Control Group2 (N=59)|
|Headache3||8 (14.3%)||1 (1.7%)|
|New heterotropia||4 (7.1%)||4 (6.8%)|
|Worsening BCVA||3 (5.4%)||4 (6.8%)|
|Eye strain||2 (3.6%)||0 (0.0%)|
|Worsening Heterotropia||0 (0.0%)||1 (1.7%)|
|Other4||4 (7.1%)||0 (0.0%)|
|Overall||14 (25.0%)||8 (13.6%)|
1 - Includes events classified with Possible, Probable, or Definite relation to study treatment. Data presented as: n (%). Participants may experience more than one AE.
2 - As Treated Population is defined as subjects with > 0% adherence of device use are in the treatment arm, otherwise control; there were no control subjects treated with the device.
3 - All cases of headaches were graded as mild in severity and all resolved without sequelae by the end of the study.
4 - Other AEs in treatment group include: Eye Twitch, Facial Redness, Increase in Frequency of Night Terrors, Dizziness, Parent-reported intermitted eye turning when tired.
Several peer-reviewed papers and abstracts have been published on the Luminopia technology by top journals in the field.
Digital Therapeutic Improves Visual Acuity and Encourages High Adherence in Amplyopic Children in Open-Label Pilot Study
xiao s, gaier eD, wu HC, et al. Journal of AAPOS 2021;25(2):87.e1-87.e6Read more
Indications, Safety and Warnings
Luminopia 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 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 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 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 therapy. Luminopia is intended for Prescription Use Only, in an at-home environment.
In the Luminopia pivotal trial, 14 patients (25%) experienced adverse events in the treatment group vs. 8 (14%) in the control group. Ocular AEs were reported in 6 (11%) patients in the treatment group and 8 (14%) patients in the control. No serious adverse events (AEs) were reported. The most frequent non-serious AE potentially related to Luminopia was headache (14.3%), for which all cases were graded as mild, transient, and resolved without sequelae.
Rx only: Federal law restricts this device on the order of a trained eye-care professional.
Safety and effectiveness of Luminopia beyond 12 weeks is unknown. The long-term effects of HMD use in patients 4-7 years of age are unknown. Patients with a history of light-induced seizures, or serious medical conditions, should contact a doctor before using Luminopia. Patients should only use Luminopia while wearing their prescribed glasses under the HMD. Patients should stop using Luminopia and contact a doctor if they experience a new or worsened eye-turn, or double vision. Patients with an interpupillary distance of less than 52 mm should not use Luminopia.