OCT Eccentric Fixation and Amblyopia in Children

Not Applicable

Recruiting

• Conditions: Amblyopia
• Interventions: Device: eye patch; Device: After-image and MIT trainer

• Registration Number: NCT05714449
• Lead Sponsor: State University of New York College of Optometry

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.

Detailed Description

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

Aim 2. OCT EF changes with foveation therapy.

Study Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-02-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-20
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-01-24
• Study Completion: 2026-01-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patching group	eye patch	part-time patching following PEDIG guidelines.
foveation therapy	After-image and MIT trainer	After-image foveation therapy training is 10 mins; MIT training is 5 minutes.

Primary Outcome Measures

Name	Time	Method
OCT eccentric fixation	12 weeks	eccentric fixation measured with OCT imaging.

Trial Locations

Locations (1)

SUNY College of Optometry; 🇺🇸 New York, New York, United States