Bilateral and Unilateral Amblyopia Treatment Study

Objective Adherence With Optical Correction in Children With Bilateral and Unilateral Refractive Amblyopia

The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.

Study Overview

• Status: Terminated
• Conditions: Amblyopia
• Intervention / Treatment: Other: Prescription glasses for bilateral amblyopia; Other: Prescription glasses for unilateral amblyopia

Detailed Description

The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Salus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children age at 3 to < 10 years, who is newly diagnosed as amblyopia and prescribed with glasses.

Description

Inclusion Criteria:

• Age 3 to < 10 years
• Subjects and their parent/guardian speak and understand English adequately to complete the study protocol and give informed consent. Subjects have the ability to adhere to the study visit schedule.
• All refractive error measures below will be determined by cycloplegic retinoscopy by one of the study investigators during the comprehensive eye exam. Measures are in minus cylinder spectacle prescription format.

Inclusion criteria for bilateral amblyopia:

The major eligibility criteria include:

• Best-corrected visual acuity of <20/30 each eye.

• For hypermetropia:

  • Spherical equivalent >+2.00 D each eye.
  • Spherical equivalent difference between eyes <1.25 D.

• For astigmatism without hypermetropia criteria above or myopia criteria below:

  • >1.75 D each eye
  • Difference between eyes <1.25 D

• For myopia:

  • Spherical equivalent <-5.00.
  • Spherical equivalent difference between eyes <1.25 D.

Inclusion criteria for unilateral amblyopia:

The major eligibility criteria include:

• Presence of anisometropia or constant unilateral strabismus.
• Best-corrected visual acuity in the amblyopic eye <20/30; and interocular difference of best-corrected visual acuity at least two logMAR lines.

• For anisometropia:

  • Spherical equivalent ≥ 1.00 D interocular difference
  • Astigmatism >1.75 D interocular difference
• For constant unilateral strabismus where spectacle prescription is indicated. Examples where spectacle prescription is indicated include esotropia caused at least in part by an accommodative component or where significant refractive error in either eye warrants spectacle prescription for improved vision.

Exclusion Criteria:

• History of spectacle wear
• Previous treatment for amblyopia
• Active amblyopia treatment planned other than spectacles at enrollment
• Prior intraocular or refractive surgery
• Ocular or systemic abnormalities that the examining investigator deems could impact prognosis for visual improvement. Examples could include birth history that may have affected brain development, extremely low birth weight (<1.5 lbs), seizure disorders, cerebral palsy, optic nerve hypoplasia, cranial nerve palsy. Examples that would usually not exclude are off axis media opacity, low birth weight (2.0-3.5 lbs) without complication, mild limitation of extraocular muscle. Cognitive impairment that prohibits accurate data collection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bilateral Group; Patients have bilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 each eye.	Other: Prescription glasses for bilateral amblyopia; Correction of refractive error with prescription glasses both eyes
Unilateral Group; Patients have unilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 in the amblyopic eye; and interocular difference of best-corrected visual acuity at least two logMAR lines.	Other: Prescription glasses for unilateral amblyopia; Correction of asymmetric refractive errors with lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity change from the baseline	visual acuity change from the baseline in logMAR	8 weeks
adherence with optical treatment	The adherence recorded with the microsensor will be calculated as a percentage.	8 weeks

Collaborators and Investigators

• Sponsor: Salus University
• Investigators: Principal Investigator: Stanley Hatch, OD, Salus University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Amblyopia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: HJWSH1810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No