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The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02799836
Recruitment Status : Withdrawn (This study never started, did not receive IRB approval and was closed administratively at the site. Therefore, no subjects were recruited or enrolled.)
First Posted : June 15, 2016
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Melanie Kazlas, Boston Children's Hospital

Tracking Information
First Submitted Date  ICMJE February 18, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date August 4, 2020
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Logmar visual acuity [ Time Frame: Measured at 60 minutes after blindfold is removed ]
  • Logmar visual acuity [ Time Frame: Measured at one week after blindfold is removed ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Official Title  ICMJE The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Amblyopia
  • Anisometropia
  • Visual Impairment
Intervention  ICMJE Device: Blindfold
Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.
Study Arms  ICMJE Experimental: Light deprived study subjects
Study subjects who are blindfolded for 48 hours
Intervention: Device: Blindfold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 31, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
12
Actual Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02799836
Other Study ID Numbers  ICMJE P00008306
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Study subject's visual acuity before and after the intervention will be given to the study subject.
Responsible Party Melanie Kazlas, Boston Children's Hospital
Study Sponsor  ICMJE Boston Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boston Children's Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP