Regimens of Intermittent Occlusion Therapy for Amblyopia in Children

NCT02767856 | Terminated Results

• 1 other identifier: HJW1604
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks? Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity Improvement

  visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method

  4 weeks for the Intense Group and 12 weeks for the Standard Group

Secondary Outcomes (3)

• Stereoacuity Test

  4 weeks for the Intense Group and 12 weeks for the Standard Group

• Objective Total Treatment Hours

  4 weeks for the Intense Group and 12 weeks for the Standard Group

• Objective Adherence

  4 weeks for the Intense Group and 12 weeks for the Standard Group

Study Arms (2)

Intense 12-hour IO-therapy Group

EXPERIMENTAL

Participants wear 12-hour daily IO-therapy glasses for 4 weeks

Device: IO-therapy Glasses

Standard 4-hour IO-therapy Group

ACTIVE COMPARATOR

Participants wear 4-hour daily IO-therapy glasses for 12 weeks

Device: IO-therapy Glasses

Interventions

IO-therapy Glasses DEVICE

Intense 12-hour IO-therapy Group; Standard 4-hour IO-therapy Group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The following criteria must be met for the patient to be enrolled in the study:
• Age 3 to \< 8 years
• Unilateral amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
• Criteria for strabismus: At least one of the following criteria must be met:
• Heterotropia at distance and/or near fixation on examination (with or without spectacles)
• History of strabismus surgery
• Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
• Criteria for anisometropia: At least one of the following criteria must be met:
• \>0.50 D difference between eyes in spherical equivalent
• \>0.50 D difference between eyes in astigmatism in any meridian
• Amblyopic eye has no myopia (\> -0.25 D spherical equivalent).
• 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 20/40 and 20/80 inclusive
• Visual acuity in the sound eye 20/32 or better
• Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity)

You may not qualify if:

• Amblyopic eye has myopia worse than -3.00 D spherical equivalent.
• Prior intraocular or refractive surgery
• Ocular pathologies that impact vision
• Cognitive impairment that prohibits accurate data collection

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Salus University

Elkins Park, Pennsylvania, United States

Location

Related Publications (1)

• Wang J, Malik A, Jin J, Pang Y, Yin K, Allen M, Grigorian A, Scombordi B, Bailey J, Aljohani S, Funari K, Shoge R, Meiyeppen S, Myung J, Soni A, Neely DE. Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):361. doi: 10.1186/s13063-020-04284-4.

  PMID: 32345348 DERIVED

MeSH Terms

Conditions

Amblyopia

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

Limitations and Caveats

Termination leads to small numbers of subjects analyzed. Several participants lost follow-up. One patient withdrew from the study due to a dislike of the device.

Results Point of Contact

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

jwang@sunyopt.edu

212-938-5759

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: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 10, 2016
• Study Start: September 1, 2016
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: July 25, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)