Light-deprivation Utilized to Mitigate Amblyopia

NCT02685423 | Unknown DMC

• 2 other identifiers: LUMA_758485R21EY025398
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Keywords

Amblyopia; Lazy Eye; Anisometropia

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Backus Lab Stereoacuity Assessment

  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.

  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

• Change from baseline in contrast sensitivity function of amblyopic eye, fellow eye, and both eyes together, using the Sentio (R) CSF measurement device

  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.

  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

• Change from baseline in acuity as measured using M&S Technologies automated ETDRS acuity test

  5-10 minute procedure to assess logMAR acuity. Data will by analyzed for each participant separately and aggregated by mean of change over time.

  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)

Secondary Outcomes (1)

• Binocular motor fusion assessment

  3 times during the 2 months before sequestration, 4 times during 12 months after sequestration

Other Outcomes (1)

• Daily self-report of visual hallucinations

  Daily during 5 or 10 days of darkness sequestration

Study Arms (2)

Visual Deprivation - 10 days

EXPERIMENTAL

10 days of visual deprivation followed by vision training

Behavioral: Binocular deprivation 10 days; Behavioral: Vision training

Vision Training Only

ACTIVE COMPARATOR

Vision training without visual deprivation

Behavioral: Vision training

Interventions

Binocular deprivation 10 days BEHAVIORAL

Research participants will be asked to live 10 days in an experimentally-controlled dark environment.

Also known as: Dark exposure 10 days, Visual deprivation 10 days, Darkness sequestration 10 days, Dark rearing 10 days

Visual Deprivation - 10 days

Vision training BEHAVIORAL

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.

Also known as: Visual therapy, Vision therapy, Visual learning, Perceptual learning

Vision Training Only; Visual Deprivation - 10 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York College of Optometry: lead
• University of Maryland, College Park: collaborator
• Nova Southeastern University: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

SUNY College of Optometry - Clinical Vision Research Center

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Amblyopia; Anisometropia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors

Study Officials

• Benjamin T Backus, PhD

  Grad Ctr for Vision Research, SUNY College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 18, 2016
• Study Start: December 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

US (1)