Clinical Trials Logo
  1. Home
  2. Amblyopia
  3. NCT02782117
  4. Details
NCT02782117 Clinical Trial

Luminopia One Pilot Study

Amblyopia Clinical Trial

Official title:
Luminopia One Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02782117
Other study ID # C-AM-1C AND C-AM-1D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date February 6, 2019

Study information
Verified date July 2020
Source Luminopia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date February 6, 2019
Est. primary completion date February 6, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 12 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Luminopia One
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.

Locations
Country Name City State
United States Indiana University Bloomington Indiana
United States Wheaton Eye Clinic Chicago Illinois
United States Concord Eye Center Concord New Hampshire
United States Children's Eye Care of Michigan Dearborn Michigan
United States Kids Eye Care of Maryland Frederick Maryland
United States Houston Eye Associates Houston Texas
United States Conestoga Eye Lancaster Pennsylvania
United States Eye Physicians of Central Florida Maitland Florida
United States Virginia Pediatric Eye Center Virginia Beach Virginia

Sponsors (2)
Lead Sponsor Collaborator
Luminopia Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amblyopic eye best-corrected visual acuity Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants = 7 years of age 12 weeks
Secondary Amblyopic eye best-corrected visual acuity Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants = 7 years of age 8 weeks
Secondary Amblyopic eye best-corrected visual acuity Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants = 7 years of age 4 weeks
Secondary Adherence Duration spent using the device divided by duration of treatment prescribed (objectively monitored) 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04238065 - A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia N/A
Completed NCT04432181 - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Terminated NCT02767856 - Regimens of Intermittent Occlusion Therapy for Amblyopia in Children N/A
Completed NCT02458846 - Efficacy of Visual Screening in Ontario N/A
Completed NCT01190813 - Levodopa for the Treatment of Residual Amblyopia Phase 3
Completed NCT01109459 - Multimodal Physician Intervention to Detect Amblyopia N/A
Completed NCT04313257 - Monocular Action Video Game Treatment of Amblyopia N/A
Completed NCT04315649 - Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops N/A
Completed NCT05223153 - OCT-A and Amblyopia
Recruiting NCT05522972 - Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games N/A
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Completed NCT02200211 - Study of Binocular Computer Activities for Treatment of Amblyopia N/A
Recruiting NCT06429280 - Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Withdrawn NCT04959422 - Assuring Ophthalmologic Follow up N/A
Active, not recruiting NCT05612568 - 5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders
Recruiting NCT03655912 - Binocular Visual Therapy and Video Games for Amblyopia Treatment. N/A
Recruiting NCT06150391 - Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program N/A
Completed NCT03754153 - Binocularly Balanced Viewing Study N/A
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1
Withdrawn NCT02594358 - Caffeine in Amblyopia Study Phase 1/Phase 2