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Indications:

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.

Safety:

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.

Warnings:

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.