Luminopia One Amblyopia Vision Improvement Study

Luminopia

Status: Completed

Conditions: Amblyopia

Treatments: Device: Luminopia One; Device: Refractive Correction

Study type: Interventional

Funder types: Industry

Identifiers

NCT03608150

C-AM-2

Details and patient eligibility

About

The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.

Full description

The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

Enrollment: 117 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 4 to 7 years at the time of consent.
• Amblyopia associated with anisometropia and/or mild strabismus.
• Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
• Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
• Fellow eye BCVA 20/32 or better.
• Interocular difference ≥ 3 logMAR lines.
• Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.

Exclusion criteria

• Atropine treatment in the past 2 weeks.
• Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
• High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
• History of low adherence with amblyopia treatment or light-induced seizures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 2 patient groups

Therapeutic Group

Experimental group

Description:

Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.

Treatment:

Device: Luminopia One

Control Group

Active Comparator group

Description:

Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.

Treatment:

Device: Refractive Correction