Bilateral and Unilateral Amblyopia Treatment Study

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03780205
• Other study ID #: HJWSH1810
• Status: Terminated
• Start date: March 20, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: August 2020
• Source: Salus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Other:
• Prescription glasses for bilateral amblyopia
Correction of refractive error with prescription glasses both eyes
• Prescription glasses for unilateral amblyopia
Correction of asymmetric refractive errors with lenses

Locations

Country	Name	City	State
United States	Salus University	Elkins Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Salus University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity change from the baseline	visual acuity change from the baseline in logMAR	8 weeks
Primary	adherence with optical treatment	The adherence recorded with the microsensor will be calculated as a percentage.	8 weeks