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Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

Primary Purpose

Amblyopia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IO-therapy Glasses

patch

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• 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
Intereye acuity difference of > 3 logMAR lines
Amblyopia associated with myopic anisometropia
Has been wearing optimal spectacle correction for a minimum of four weeks

Sites / Locations

Salus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

12-hour IO-therapy Glasses

6-hour patching

Arm Description

wear IO-therapy glasses for 12-hour

wear the eye patch for 6-hour

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02687581

First Posted

February 16, 2016

Last Updated

November 1, 2022

Sponsor

Salus University

Collaborators

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT02687581

Brief Title

Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

Official Title

Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Enrollment is challenging and study materials were not produced any more.

Study Start Date

December 19, 2016 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Salus University

Collaborators

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Children ages 3 to < 8 years with severe/dense 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. Children ages 3 to < 8 years with deprivation amblyopia associated with congenital or developmental cataracts (visual acuity of 20/40 to 20/400 in the amblyopic eye) will be enrolled. Children ages 3 to < 8 years with myopic anisometropic amblyopia will be enrolled into an intermittent occlusion therapy glasses (AmblyzTM) group. According to visual acuity, they will receive one of two IO-therapy glasses treatment regimens: 1) If the amblyopic eye is between 20/40 to 20/80 inclusive, 4-hour IO-therapy glasses or 2) If the amblyopic eye is between 20/100 to 20/400 inclusive, the child will receive12-hour IO-therapy glasses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amblyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12-hour IO-therapy Glasses

Arm Type

Experimental

Arm Description

wear IO-therapy glasses for 12-hour

Arm Title

6-hour patching

Arm Type

Active Comparator

Arm Description

wear the eye patch for 6-hour

Intervention Type

Device

Intervention Name(s)

IO-therapy Glasses

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

patch

Intervention Description

6-hour of eye patch on the fellow eye

Primary Outcome Measure Information:

Title

Visual Acuity Improvement

Description

Time Frame

12± 1 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: • 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 Intereye acuity difference of > 3 logMAR lines Amblyopia associated with myopic anisometropia Has been wearing optimal spectacle correction for a minimum of four weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jingyun Wang, PhD

Organizational Affiliation

Salus University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Salus University

City

Elkins Park

State/Province

Pennsylvania

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

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