Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT03608150
Brief Summary:
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.
Detailed 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.
Study:
NCT03608150
Study Brief:
Protocol Section:
NCT03608150