Bilateral and Unilateral Amblyopia Treatment Study

NCT03780205 | Terminated

• 1 other identifier: HJWSH1810
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Keywords

Amblyopia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Prescription glasses for bilateral amblyopia OTHER

Correction of refractive error with prescription glasses both eyes

Bilateral Group

Prescription glasses for unilateral amblyopia OTHER

Correction of asymmetric refractive errors with lenses

Unilateral Group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Salus University

Elkins Park, Pennsylvania, 19027, United States

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanley Hatch, OD

  Salus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: March 20, 2019
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

US (1)