Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

NCT02687581 | Terminated Results

• 1 other identifier: HJW1602
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia. Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group. The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity Improvement

  Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.

  12± 1 weeks after treatment

Study Arms (2)

12-hour IO-therapy Glasses

EXPERIMENTAL

wear IO-therapy glasses for 12-hour

Device: IO-therapy Glasses

6-hour patching

ACTIVE COMPARATOR

wear the eye patch for 6-hour

Device: patch

Interventions

IO-therapy Glasses DEVICE

12-hour of 50% intermittent occlusion therapy on the fellow eye.

12-hour IO-therapy Glasses

patch DEVICE

6-hour of eye patch on the fellow eye

6-hour patching

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to \< 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
• Visual acuity in the amblyopic eye between 20/100 and 20/400 inclusive
• Visual acuity in the sound eye 20/32 or better
• Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
• Requirements for spectacle correction:
• For patients meeting criteria for only strabismus i. Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion.
• For patients meeting criteria for anisometropia or combined-mechanism i. Spherical equivalent must be within 0.50 D of fully correcting the anisometropia ii. Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes iii. Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism iv. Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
• Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
• Gestational age \> 34 weeks and birth weight \> 1500 grams
• Parent willing to accept randomization
• Parent willing to be contacted and has access to phone
• Parent does not anticipate relocation outside area of active study site

You may not qualify if:

• Amblyopic eye has myopia worse than -3.00D spherical equivalent.
• Previous amblyopia treatment within 6 months.
• Prior intraocular or refractive surgery
• Known skin reactions to patch or bandage adhesives
• Systemic diseases that may cause reduced vision such as Down syndrome.
• If patients are in the deprivation amblyopia category, the following criteria must be met for the patient to be enrolled in the study:
• Age 3 to \< 8 years
• Amblyopia due to previous congenital or developmental cataract surgery.
• Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
• a. Visual acuity in the amblyopic eye between 20/40 and 20/400 inclusive b. Visual acuity in the sound eye 20/32 or better c. Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 3 lines worse than sound eye acuity) d) Gestational age \> 34 weeks and birth weight \> 1500 grams e) Parent willing to be contacted and has access to phone.
• If patients are enrolled in the myopic anisometropia amblyopia category, the following criteria must be met for the patients to be enrolled in the study.
• Aged 3 to \<8 years
• Best-corrected VA in the amblyopic eye of 20/40 to 20/400 inclusive
• Best-corrected VA in the fellow eye of 20/40 or better
• Magnitude of myopic anisometropia of \> 3.00 D

Sponsors & Collaborators

• Salus University: lead
• Indiana University: collaborator

Study Sites (1)

Salus University

Elkins Park, Pennsylvania, United States

Location

MeSH Terms

Conditions

Amblyopia

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

This trial is limited in enrollment. The device has only one size and it did not fit a patient in the Amblyz group. We are not sure if some patients in that group lost follow-up because of the size of the glasses. Due to the small sample size, we are not able to draw a conclusion.

Results Point of Contact

• Title: Dr. Jingyun Wang
• Organization: State University of New York College of Optometry

jwang@sunyopt.edu

212-938-5759

Study Officials

• Jingyun Wang, PhD

  Salus University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 22, 2016
• Study Start: December 19, 2016
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: November 22, 2022
• Results First Posted: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)