OCT Eccentric Fixation and Amblyopia in Children

State University of New York College of Optometry

Status: Enrolling

Conditions: Amblyopia

Treatments: Device: After-image and MIT trainer; Device: eye patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05714449

1912342

Details and patient eligibility

About

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.

Full description

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

Aim 2. OCT EF changes with foveation therapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Patching group

Experimental group

Description:

part-time patching following PEDIG guidelines.

Treatment:

Device: eye patch

foveation therapy

Experimental group

Description:

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

Treatment:

Device: After-image and MIT trainer