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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Withdrawn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
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 18, 2016
    Last Updated
    July 31, 2020
    Sponsor
    Boston Children's Hospital
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    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    Withdrawn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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