Recruiting

OCT Eccentric Fixation

Sponsor:

State University of New York College of Optometry

Code:

NCT05714449

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 4 - 16

Healthy Volunteers: Not accepted

Interventions

eye patch

After-image and MIT trainer

Study Details

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.

Conditions

Amblyopia

Study ID

NCT05714449

Start date

Jan 25, 2023

Status verified date

Apr, 2024

Completion date

Jan 24, 2026

Anticipated

Primary completion date

Jan 24, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 16

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patching group

part-time patching following PEDIG guidelines.

experimental: foveation therapy

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

Interventions

eye patch

standard amblyopia treatment

After-image and MIT trainer

Common clinical training for foveation

Primary outcome measure

  • OCT eccentric fixation [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

SUNY College of Optometry

Recruiting

New York, New York, United States, 10036

More Information

Sponsor

State University of New York College of Optometry

Last update posted

Apr 23, 2024

Last verified

Apr, 2024

Keywords

  • eccentric fixation
  • amblyopia
  • patching
  • foveation therapy
  • OCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York College of Optometry on 2024-04-23.