The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

Amblyopia Clinical Trial

Official title:

The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02799836
• Other study ID #: P00008306
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Anisometropia
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Logmar visual acuity		Measured at 60 minutes after blindfold is removed
Primary	Logmar visual acuity		Measured at one week after blindfold is removed