The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

NCT ID: NCT02799836

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Light deprived study subjects

Study subjects who are blindfolded for 48 hours

Group Type: EXPERIMENTAL

Blindfold

Intervention Type: DEVICE

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

Interventions

Blindfold

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Melanie Kazlas

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P00008306

Identifier Type: -

Identifier Source: org_study_id