OCT Eccentric Fixation and Amblyopia in Children

• Sponsor: State University of New York College of Optometry (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05714449
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Amblyopia	Device: eye patch; Device: After-image and MIT trainer	N/A

Detailed Description

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

Aim 2. OCT EF changes with foveation therapy.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children
• Anticipated Study Start Date: Jan 25, 2023
• Anticipated Primary Completion Date: Jan 24, 2025
• Anticipated Study Completion Date: Jan 24, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. OCT eccentric fixation [12 weeks]

   eccentric fixation measured with OCT imaging.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, b) 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; and 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:

• children born before 32 weeks gestational age; those with neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies; and those with congenital or acquired macular pathology.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• State University of New York College of Optometry

Investigators

• Principal Investigator: Jingyun Wang, SUNY College of Optmetry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jingyun Wang, Associate Professor, State University of New York College of Optometry
• ClinicalTrials.gov Identifier: NCT05714449
• Other Study ID Numbers: 1912342
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jingyun Wang, Associate Professor, State University of New York College of Optometry: eccentric fixation, amblyopia, patching, foveation therapy
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Feb 6, 2023