OCT Eccentric Fixation and Amblyopia in Children

Amblyopia Clinical Trial

Official title:

OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714449
• Other study ID #: 1912342
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: January 24, 2026

Study information

• Verified date: April 2024
• Source: State University of New York College of Optometry
• Contact: Jingyun Wang, PhD
• Phone: 2129385759
• Email: jwang[@]sunyopt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aim 1. OCT EF changes with patching treatment at 12 weeks visit.

Aim 2. OCT EF changes with foveation therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 24, 2026
• Est. primary completion date: January 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

1. 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,

2. 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.

Exclusion Criteria:

• born before 32 weeks gestational age;

• neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies;

• congenital or acquired macular pathology.

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• eye patch
standard amblyopia treatment
• After-image and MIT trainer
Common clinical training for foveation

Locations

Country	Name	City	State
United States	SUNY College of Optometry	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York College of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT eccentric fixation	eccentric fixation measured with OCT imaging.	12 weeks