Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (This study never started, did not receive IRB approval and was closed administratively at the site.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

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.

Condition or disease Intervention/treatment Phase
Amblyopia Anisometropia Visual Impairment Device: Blindfold Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2020
Actual Study Completion Date : June 1, 2020

Arm Intervention/treatment
Experimental: Light deprived study subjects
Study subjects who are blindfolded for 48 hours
Device: Blindfold
Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.




Primary Outcome Measures :
  1. Logmar visual acuity [ Time Frame: Measured at 60 minutes after blindfold is removed ]
  2. Logmar visual acuity [ Time Frame: Measured at one week after blindfold is removed ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Layout table for additonal information
Responsible Party: Melanie Kazlas, PI, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02799836    
Other Study ID Numbers: P00008306
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study subject's visual acuity before and after the intervention will be given to the study subject.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Amblyopia
Vision Disorders
Vision, Low
Anisometropia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Refractive Errors