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Light-deprivation Utilized to Mitigate Amblyopia (LUMA)

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ClinicalTrials.gov Identifier: NCT02685423
Recruitment Status : Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
University of Maryland, College Park
Nova Southeastern University
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ben Backus, State University of New York College of Optometry

Brief Summary:
Amblyopia is an impairment in spatial vision caused by asymmetry in the quality of visual input across the two eyes during childhood. It is difficult to treat in adulthood because the visual system becomes less "plastic" (able to learn) with age. The purpose of this study is to determine whether five to ten days of visual deprivation--living in complete darkness--can enhance plasticity in the visual cortex and thereby facilitate the learning that is needed to recover visual function in amblyopic adults.

Condition or disease Intervention/treatment Phase
Amblyopia Behavioral: Binocular deprivation 10 days Behavioral: Vision training Not Applicable

Detailed Description:

An asymmetry in the visual input across the eyes early in postnatal life causes amblyopia, the most common basis of uni-ocular blindness in humans. If uncorrected, amblyopia results in the unaffected eye controlling the binocular visual cortex, while the ability of the affected eye to stimulate cortical neurons may weaken to the point of functional blindness. Previous attempts to recover vision in adult amblyopes have had limited success, and the investigators propose this is due in large part to the significant reduction of synaptic plasticity that occurs during cortical development. The investigators propose that optimal recovery from amblyopia in adulthood is a two stage process that requires 1) the reactivation of plasticity in the adult amblyopic cortex (permissive step) and 2) focused visual experience to stimulate perceptual learning (instructive step).

The Elizabeth Quinlan lab at the University of Maryland has recently shown that binocular visual deprivation in adulthood enhances synaptic plasticity in the adult cortex of experimental animals in as little as three days. In addition, binocular visual deprivation prior to repetitive visual experience stimulates the recovery of spatial acuity in an animal model of deep amblyopia. Here the investigators propose to translate this finding to the treatment of amblyopia in humans. The investigators propose to use binocular visual deprivation to promote synaptic plasticity in the amblyopic visual cortex, followed by visual perceptual learning through vision therapy homework, to stimulate the recovery of visual function. While visual perceptual learning has been previously shown to enhance visual function in amblyopic adults, the gains are slow and modest. The investigators predict that "pre-treatment" of the amblyopic visual system with binocular visual deprivation will enhance the magnitude and/or time course of learning-induced recovery from amblyopia.

Twenty-four adult amblyopes, age 18 or older, will be recruited for the study. The investigators will exclude amblyopes with strabismus history because the treatment has not been designed to improve binocular alignment (motor fusion). Thus, amblyopes will be form deprivation amblyopes, especially form deprivation due to anisometropia, with moderate (20/30 to 20/80) or severe (20/100 to 20/400) acuity in the affected eye. Screening will include an extensive application, telephone interview of two personal references, comprehensive visual examination, and in-person interview.

Participants will be fitted with new ophthalmics if indicated and followed for several weeks to allow their amblyopia to stabilize. Their visual function will be assessed behaviorally and also by direct measurement of neural activity using visually evoked potentials (VEPs). Participants will be assigned to one of three groups. One group will be sequestered for zero days, one for five continuous days, and one for ten continuous days. Participants in the five or ten day sequestration groups will undergo sequestration in groups of two, three, or four. After sequestration visual function will again be assessed, both behaviorally and with VEP. All participants will then undergo 8 weeks (3 weeks before, 5 weeks after) of vision treatment for amblyopia, based on video game play. Vision testing will occur regularly during this period and for 10 months thereafter. A third VEP scan will be done at the end of the 8 week treatment period.

If successful, this work would transform therapy for adult amblyopia, and focus attention on the importance of incorporating methods to enhance synaptic plasticity as an adjunct to treatment. In addition, the insight gained from this work could be extended to strabismus, eye movement control disorders, and the restoration of optimal neural function after damage from stroke or other traumatic brain injury. The proposed experiment will also pioneer the use of binocular visual deprivation in human amblyopes, and develop standards for implementation, participant sequestration and care.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimized Visual Recovery in Adult Human Amblyopia Through Binocular Deprivation
Actual Study Start Date : December 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Experimental: Visual Deprivation - 10 days
10 days of visual deprivation followed by vision training
Behavioral: Binocular deprivation 10 days
Research participants will be asked to live 10 days in an experimentally-controlled dark environment.
Other Names:
  • Dark exposure 10 days
  • Visual deprivation 10 days
  • Darkness sequestration 10 days
  • Dark rearing 10 days

Behavioral: Vision training
Subjects will play a video game on their VR headset for 24 minutes per day, followed by 20 minutes of binocular experience with a brightness-reducing filter over the non-amblyopic eye.
Other Names:
  • Visual therapy
  • Vision therapy
  • Visual learning
  • Perceptual learning

Active Comparator: Vision Training Only
Vision training without visual deprivation
Behavioral: Vision training
Subjects will play a video game on their VR headset for 24 minutes per day, followed by 20 minutes of binocular experience with a brightness-reducing filter over the non-amblyopic eye.
Other Names:
  • Visual therapy
  • Vision therapy
  • Visual learning
  • Perceptual learning




Primary Outcome Measures :
  1. Change from baseline in Backus Lab Stereoacuity Assessment [ Time Frame: Twice during the two weeks before sequestration to establish baseline, and again after sequestration: twice weekly for 2 weeks, then weekly for 2 weeks, then 2 times during the next month, monthly for 4 months, and then once every two months for 6 months ]
    4-alternative forced choice task in a stereoscope in the Backus lab. Data will by analyzed for each participant separately and aggregated by mean of change over time.

  2. Change from baseline in contrast sensitivity function of amblyopic eye, fellow eye, and both eyes together, using the Sentio (R) CSF measurement device [ Time Frame: Twice during the two weeks before sequestration to establish baseline, and again after sequestration: twice weekly for 2 weeks, then weekly for 2 weeks, then 2 times during the next month, monthly for 4 months, and then once every two months for 6 months ]
    15-20 minute procedure to assess CSF in the amblyopic eye, fellow eye, and using both eyes together. Data will by analyzed for each participant separately and aggregated by mean of change over time.

  3. Change from baseline in acuity as measured using M&S Technologies automated ETDRS acuity test [ Time Frame: Three times during the 2 months before sequestration to establish baseline, and again after sequestration: once a week for 2 weeks, then once a month for 2 months, then once every 3 months until study completion (at approximately 1 year) ]
    5-10 minute procedure to assess logMAR acuity. Data will by analyzed for each participant separately and aggregated by mean of change over time.


Secondary Outcome Measures :
  1. Binocular motor fusion assessment [ Time Frame: 3 times during the 2 months before sequestration, 4 times during 12 months after sequestration ]
    vergence range measured with standard clinical assessment (binocular fixation of varied-distance target). Data will not be aggregated.


Other Outcome Measures:
  1. Daily self-report of visual hallucinations [ Time Frame: Daily during 5 or 10 days of darkness sequestration ]
    Participants will make daily auditory recording to document any hallucinations (or other remarkable phenomena related to their mental or physical state).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults age 18 or older
  • Moderate (20/30 to 20/80) to severe (20/100 to 20/400) amblyopia with a visual acuity of 20/25 or better in the fellow eye
  • Must live in or be commutable to the New York Metropolitan area

Exclusion Criteria:

  • individuals with study-relevant phobias, anxiety disorders or other mental health disorders will be excluded, as will people taking anti-depressant or anti-anxiety drugs
  • Must pass all stages of application process:

    • Review of full application
    • Phone interview
    • Telephone interview of two personal references
    • On-site eligibility screening evaluation
    • On-site complete ophthalmic evaluation
    • Criminal background check
    • On-site personal interview
    • Psychological exam
    • Physical exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685423


Locations
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United States, New York
SUNY College of Optometry - Clinical Vision Research Center
New York, New York, United States, 10036
Sponsors and Collaborators
State University of New York College of Optometry
University of Maryland, College Park
Nova Southeastern University
National Eye Institute (NEI)
Investigators
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Principal Investigator: Benjamin T Backus, PhD Grad Ctr for Vision Research, SUNY College of Optometry

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Responsible Party: Ben Backus, Associate Professor, State University of New York College of Optometry
ClinicalTrials.gov Identifier: NCT02685423     History of Changes
Other Study ID Numbers: LUMA_758485
R21EY025398 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ben Backus, State University of New York College of Optometry:
Amblyopia
Lazy Eye
Anisometropia
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms