The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

NCT02799836 | Withdrawn DMC

• 1 other identifier: P00008306
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amblyopia; Anisometropia; Visual Impairment

Outcome Measures

Primary Outcomes (2)

• Logmar visual acuity

  Measured at 60 minutes after blindfold is removed

• Logmar visual acuity

  Measured at one week after blindfold is removed

Study Arms (1)

Light deprived study subjects

EXPERIMENTAL

Study subjects who are blindfolded for 48 hours

Device: Blindfold

Interventions

Blindfold DEVICE

Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.

Light deprived study subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Amblyopia; Anisometropia; Vision Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: June 15, 2016
• Study Start: August 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share