search
Back to results

OCT Eccentric Fixation and Amblyopia in Children

Primary Purpose

Amblyopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eye patch
After-image and MIT trainer
Sponsored by
State University of New York College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring eccentric fixation, amblyopia, patching, foveation therapy, OCT

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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, 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.

Sites / Locations

  • SUNY College of OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patching group

foveation therapy

Arm Description

part-time patching following PEDIG guidelines.

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

Outcomes

Primary Outcome Measures

OCT eccentric fixation
eccentric fixation measured with OCT imaging.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
August 14, 2023
Sponsor
State University of New York College of Optometry
search

1. Study Identification

Unique Protocol Identification Number
NCT05714449
Brief Title
OCT Eccentric Fixation and Amblyopia in Children
Official Title
OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
January 24, 2025 (Anticipated)
Study Completion Date
January 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York College of Optometry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
eccentric fixation, amblyopia, patching, foveation therapy, OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patching group
Arm Type
Experimental
Arm Description
part-time patching following PEDIG guidelines.
Arm Title
foveation therapy
Arm Type
Experimental
Arm Description
After-image foveation therapy training is 10 mins; MIT training is 5 minutes.
Intervention Type
Device
Intervention Name(s)
eye patch
Intervention Description
standard amblyopia treatment
Intervention Type
Device
Intervention Name(s)
After-image and MIT trainer
Intervention Description
Common clinical training for foveation
Primary Outcome Measure Information:
Title
OCT eccentric fixation
Description
eccentric fixation measured with OCT imaging.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyun Wang, PhD
Phone
2129385759
Email
jwang@sunyopt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingyun Wang
Organizational Affiliation
SUNY College of Optmetry
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyun Wang

12. IPD Sharing Statement

Learn more about this trial

OCT Eccentric Fixation and Amblyopia in Children

We'll reach out to this number within 24 hrs