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Bilateral and Unilateral Amblyopia Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780205
Recruitment Status : Terminated (Unable to recruit sufficient number of subjects)
First Posted : December 19, 2018
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Stanley Hatch, OD, MPH, Salus University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780205


Locations
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United States, Pennsylvania
Salus University
Elkins Park, Pennsylvania, United States, 19027
Sponsors and Collaborators
Salus University
Investigators
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Principal Investigator: Stanley Hatch, OD Salus University
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Responsible Party: Stanley Hatch, OD, MPH, Associate Professor, Salus University
ClinicalTrials.gov Identifier: NCT03780205    
Other Study ID Numbers: HJWSH1810
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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