OCT Eccentric Fixation and Amblyopia in Children

April 20, 2024 updated by: Jingyun Wang, State University of New York College of Optometry

OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Aim 2. OCT EF changes with foveation therapy.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10036
        • Recruiting
        • SUNY College of Optometry
        • Contact:
          • Jingyun Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patching group
part-time patching following PEDIG guidelines.
Device: eye patch
standard amblyopia treatment
Experimental: foveation therapy
After-image foveation therapy training is 10 mins; MIT training is 5 minutes.
Device: After-image and MIT trainer
Common clinical training for foveation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT eccentric fixation
Time Frame: 12 weeks
eccentric fixation measured with OCT imaging.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York College of Optometry

Investigators

  • Principal Investigator: Jingyun Wang, SUNY College of Optmetry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

January 24, 2025

Study Completion (Estimated)

January 24, 2026

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912342

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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