The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Primary Purpose
Amblyopia, Anisometropia, Visual Impairment
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blindfold
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Light deprived study subjects
Arm Description
Study subjects who are blindfolded for 48 hours
Outcomes
Primary Outcome Measures
Logmar visual acuity
Logmar visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT02799836
First Posted
February 18, 2016
Last Updated
July 31, 2020
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02799836
Brief Title
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Official Title
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
This study never started, did not receive IRB approval and was closed administratively at the site. Therefore, no subjects were recruited or enrolled.
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Anisometropia, Visual Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light deprived study subjects
Arm Type
Experimental
Arm Description
Study subjects who are blindfolded for 48 hours
Intervention Type
Device
Intervention Name(s)
Blindfold
Intervention Description
Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.
Primary Outcome Measure Information:
Title
Logmar visual acuity
Time Frame
Measured at 60 minutes after blindfold is removed
Title
Logmar visual acuity
Time Frame
Measured at one week after blindfold is removed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study subject's visual acuity before and after the intervention will be given to the study subject.
Learn more about this trial
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
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