Bilateral and Unilateral Amblyopia Treatment Study

NCT ID: NCT03780205

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2020-07-07

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.

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.

Conditions

Amblyopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral Group

Patients have bilateral amblyopia, which is defined that best-corrected visual acuity of \<20/30 each eye.

Prescription glasses for bilateral amblyopia

Intervention Type: OTHER

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.

Prescription glasses for unilateral amblyopia

Intervention Type: OTHER

Correction of asymmetric refractive errors with lenses

Interventions

Prescription glasses for bilateral amblyopia

Correction of refractive error with prescription glasses both eyes

Intervention Type: OTHER

Prescription glasses for unilateral amblyopia

Correction of asymmetric refractive errors with lenses

Intervention Type: OTHER

Eligibility 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.

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.

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salus University

OTHER

Sponsor Role: lead

Responsible Party

Stanley Hatch, OD, MPH

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanley Hatch, OD

Role: PRINCIPAL_INVESTIGATOR

Salus University

Locations

Salus University

Elkins Park, Pennsylvania, United States

Countries

United States

Other Identifiers

HJWSH1810

Identifier Type: -

Identifier Source: org_study_id