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Clinical Trials/NCT02782117
NCT02782117
Completed
Not Applicable

Luminopia One Pilot Study

Luminopia9 sites in 1 country84 target enrollmentStarted: August 1, 2017Last updated:
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ConditionsAmblyopia

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Luminopia
Enrollment
84
Locations
9
Primary Endpoint
Amblyopic eye best-corrected visual acuity
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
4 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Amblyopic eye best-corrected visual acuity

Time Frame: 12 weeks

Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Secondary Outcomes

  • Amblyopic eye best-corrected visual acuity(4 weeks)
  • Adherence(12 weeks)

Investigators

Sponsor
Luminopia
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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