The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

Not Applicable

Withdrawn

• Conditions: Amblyopia; Visual Impairment; Anisometropia
• Interventions: Device: Blindfold

• Registration Number: NCT02799836
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Amblyopia is a significant health problem, affecting up to 4% of the population in the United States. Amblyopia, commonly known as "lazy eye," is a developmental visual disorder in which one or both eyes suffer from poor vision as a result of being disadvantaged in early life. Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most common causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is not initiated during the critical period of visual development, lasting visual impairment may persist throughout life. This critical period of visual development has been thought to end around age 10. However, recent research has demonstrated that the critical period of visual development can be extended into adulthood. Complete light deprivation in animal models has restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light deprivation on visual function in a cohort of human adults with severe amblyopia from anisometropia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Study Start: 2019-08-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-06-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia
• Age 18-50 years

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Exclusion Criteria

• Strabismus
• Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma,
• Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Light deprived study subjects	Blindfold	Study subjects who are blindfolded for 48 hours

Primary Outcome Measures

Name	Time	Method
Logmar visual acuity	Measured at one week after blindfold is removed