Bilateral and Unilateral Amblyopia Treatment Study

• ClinicalTrials.gov Identifier: NCT03780205
• Recruitment Status: Terminated
• First Posted: December 19, 2018
• Last Update Posted: August 31, 2020
• Sponsor: Salus University
• Information provided by (Responsible Party): Stanley Hatch, OD, MPH, Salus University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Amblyopia	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 Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Objective Adherence With Optical Correction in Children With Bilateral and Unilateral Refractive Amblyopia
• Actual Study Start Date: March 20, 2019
• Actual Primary Completion Date: July 7, 2020
• Actual Study Completion Date: July 7, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. visual acuity change from the baseline [ Time Frame: 8 weeks ]
   visual acuity change from the baseline in logMAR
2. adherence with optical treatment [ Time Frame: 8 weeks ]
   The adherence recorded with the microsensor will be calculated as a percentage.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 10 Years (Child)
• Sexes 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.

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Salus University

Elkins Park, Pennsylvania, United States, 19027

Sponsors and Collaborators

Salus University

Investigators

• Principal Investigator: Stanley Hatch, OD; Salus University

More Information

• Responsible Party: Stanley Hatch, OD, MPH, Associate Professor, Salus University
• ClinicalTrials.gov Identifier: NCT03780205
• Other Study ID Numbers: HJWSH1810
• First Posted: December 19, 2018
• Last Update Posted: August 31, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stanley Hatch, OD, MPH, Salus University:

Amblyopia

Additional relevant MeSH terms:

Amblyopia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors