NCT05714449

Brief Summary

The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 25, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2026

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

January 26, 2023

Last Update Submit

April 20, 2024

Conditions

Amblyopia

Keywords

eccentric fixationamblyopiapatchingfoveation therapyOCT

Outcome Measures

Primary Outcomes (1)

  • OCT eccentric fixation

    eccentric fixation measured with OCT imaging.

    12 weeks

Study Arms (2)

Patching group

EXPERIMENTAL

part-time patching following PEDIG guidelines.

Device: eye patch

foveation therapy

EXPERIMENTAL

After-image foveation therapy training is 10 mins; MIT training is 5 minutes.

Device: After-image and MIT trainer

Interventions

eye patchDEVICE

standard amblyopia treatment

Patching group
After-image and MIT trainerDEVICE

Common clinical training for foveation

foveation therapy

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with best-corrected visual acuity (BCVA) of 20/40 (equivalent to 0.3 logMAR) or worse in the amblyopic eye (ranging from 20/40 to 20/400), and interocular difference of BCVA was at least two logMAR lines,
  • ocular causes of amblyopia that were identified as refractive(i.e., anisometropic, strabismus, or strabismic-anisometropic.
  • Anisometropia included interocular difference of spherical equivalent \>=1D or interocular difference of astigmatism cylinder magnitude \>=1D;
  • strabismus included those with deviation \>=10PD or good alignment after prior strabismus surgery;
  • combined type included those who meet the criteria of both anisometropia and strabismus.
  • For the patching group, we will enroll 15 children with strabismic amblyopia who are prescribed patching treatment. Age: 4-12 years old.
  • For the foveation therapy group, we will enroll 15 children with strabismic amblyopia who are prescribed foveation therapies. Age: 8-16 years old.

You may not qualify if:

  • born before 32 weeks gestational age;
  • neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies;
  • congenital or acquired macular pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY College of Optometry

New York, New York, 10036, United States

RECRUITING

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 Officials

  • Jingyun Wang

    SUNY College of Optmetry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyun Wang, PhD

CONTACT

2129385759jwang@sunyopt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

January 25, 2023

Primary Completion

January 24, 2025

Study Completion

January 24, 2026

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(1)