The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

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.

Study Overview

• Status: Withdrawn
• Conditions: Visual Impairment; Amblyopia; Anisometropia
• Intervention / Treatment: Device: Blindfold

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light deprived study subjects; Study subjects who are blindfolded for 48 hours	Device: Blindfold; Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Logmar visual acuity	Measured at 60 minutes after blindfold is removed
Logmar visual acuity	Measured at one week after blindfold is removed

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision, Low; Vision Disorders; Amblyopia; Anisometropia
• Other Study ID Numbers: P00008306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study subject's visual acuity before and after the intervention will be given to the study subject.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No