OCT Eccentric Fixation and Amblyopia in Children

NCT ID: NCT05714449

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2026-01-24

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.

Conditions

Amblyopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patching group

part-time patching following PEDIG guidelines.

Group Type: EXPERIMENTAL

eye patch

Intervention Type: DEVICE

standard amblyopia treatment

foveation therapy

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

Group Type: EXPERIMENTAL

After-image and MIT trainer

Intervention Type: DEVICE

Common clinical training for foveation

Interventions

eye patch

standard amblyopia treatment

Intervention Type: DEVICE

After-image and MIT trainer

Common clinical training for foveation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Jingyun Wang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingyun Wang

Role: PRINCIPAL_INVESTIGATOR

SUNY College of Optmetry

Locations

SUNY College of Optometry

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jingyun Wang, PhD

Role: CONTACT

jwang@sunyopt.edu

2129385759

Facility Contacts

Jingyun Wang

Role: primary

Other Identifiers

1912342

Identifier Type: -

Identifier Source: org_study_id