NCT02970708

Brief Summary

To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

November 17, 2016

Last Update Submit

November 17, 2016

Conditions

Amblyopia, Anisometropic

Outcome Measures

Primary Outcomes (1)

  • best corrected visual acuity

    have an improvement of best corrected visual acuity in the amblyopic eyes

    6 months

Secondary Outcomes (5)

  • stereocuity

    6 months

  • contrast sensitivity function

    6 months

  • visual evoked potential

    6 months

  • functional MRI

    6 months

  • best corrected visual acuity

    a year and a half

Study Arms (2)

EFG group

EXPERIMENTAL

amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.

Device: EFG group

Patching group

ACTIVE COMPARATOR

amblyopia in patching group will receive patching treatment.

Device: Patching group

Interventions

EFG groupDEVICE

88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.

EFG group
Patching groupDEVICE

88 anisometropic amblyopia will be recruited to receive patching treatment.

Patching group

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged from 4 to 13 years old
  • the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes
  • anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more.
  • no amblyopia treatment one month prior to the study except refractive correction.
  • myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
  • willing to participate in this study and be able to follow up on time

You may not qualify if:

  • ocular disease and other disease that have an influence on the visual acuity
  • history of ocular surgery that have an influence on the visual acuity
  • the patient is receiving other amblyopia treatment except refractive correction
  • a family or personal history of seizures
  • the patient is using some medicine that may have an influence on visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 22, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

January 1, 2020

Last Updated

November 22, 2016

Record last verified: 2016-11