Luminopia One Pilot Study

Luminopia

Status: Completed

Conditions: Amblyopia

Treatments: Device: Luminopia One

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02782117

C-AM-1C AND C-AM-1D

Details and patient eligibility

About

A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.

Enrollment: 84 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Eligibility Criteria:

• Age 4 to <8 years (phase 1) or age 4 to <13 years (phase 2)
• Monocular amblyopia associated with anisometropia, strabismus or both combined
• Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)
• Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)
• Interocular BCVA difference ≥3 lines (≥0.3 logMAR)
• Visual acuity stability in current refractive correction (phase 2)
• Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Treatment Regimen A

Experimental group

Description:

Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.

Treatment:

Device: Luminopia One