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Bilateral and Unilateral Amblyopia Treatment Study

Sponsor
Salus University (Other)
Overall Status
Terminated
CT.gov ID
NCT03780205
Collaborator
(none)
1
Enrollment
1
Location
15.6
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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 Phase
  • 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 :
Mar 20, 2019
Actual Primary Completion Date :
Jul 7, 2020
Actual Study Completion Date :
Jul 7, 2020

Arms and Interventions

Arm 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 [8 weeks]

    visual acuity change from the baseline in logMAR

  2. adherence with optical treatment [8 weeks]

    The adherence recorded with the microsensor will be calculated as a percentage.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
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

Site City State Country Postal Code
1 Salus University Elkins Park Pennsylvania United States 19027

Sponsors and Collaborators

  • Salus University

Investigators

  • Principal Investigator: Stanley Hatch, OD, Salus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanley Hatch, OD, MPH, Associate Professor, Salus University
ClinicalTrials.gov Identifier:
NCT03780205
Other Study ID Numbers:
  • HJWSH1810
First Posted:
Dec 19, 2018
Last Update Posted:
Aug 31, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, Associate Professor, Salus University
Amblyopia
Additional relevant MeSH terms:
Amblyopia
Methamphetamine

Study Results

No Results Posted as of Aug 31, 2020