AmblyopiaLUMANCT02685423
Light-deprivation Utilized to Mitigate Amblyopia
A study testing Binocular deprivation 10 days and Vision training in people with Amblyopia, run by State University of New York College of Optometry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Binocular deprivation 10 days and Vision training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- On-site complete ophthalmic evaluation
- Criminal background check
- On-site personal interview
- Psychological exam
- Physical exam
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY College of Optometry - Clinical Vision Research Center
New York, New York, 10036
About this study
Official title: Optimized Visual Recovery in Adult Human Amblyopia Through Binocular Deprivation
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.
Read the 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.
- Conditions
- Amblyopia
- Being tested
- Binocular deprivation 10 days, Vision training
- Keywords
- Amblyopia, Lazy Eye, Anisometropia
- Medical subject headings
- Amblyopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular deprivation 10 daysBehavioural
Also called Dark exposure 10 days, Visual deprivation 10 days, Darkness sequestration 10 days, Dark rearing 10 days
Research participants will be asked to live 10 days in an experimentally-controlled dark environment.
Vision trainingBehavioural
Also called Visual therapy, Vision therapy, Visual learning, Perceptual learning
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.
| Study group | Role | What they receive |
|---|---|---|
| Visual Deprivation - 10 days | Experimental | 10 days of visual deprivation followed by vision training Receives: Behavioral: Binocular deprivation 10 days; Behavioral: Vision training |
| Vision Training Only | Active comparator | Vision training without visual deprivation Receives: Behavioral: Vision training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
vergence range measured with standard clinical assessment (binocular fixation of varied-distance target). Data will not be aggregated.
Measured: 3 times during the 2 months before sequestration, 4 times during 12 months after sequestration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startDec 2016
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park, Nova Southeastern University, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Ben Backus, State University of New York College of Optometry
- Investigators
- Benjamin T Backus, PhD, Principal investigator, Grad Ctr for Vision Research, SUNY College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685423
- Sponsor's protocol ID
- LUMA_758485
- Other IDs
- R21EY025398
- Acronym
- LUMA
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2016
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Visual Recovery in Adult Human Amblyopia Through Binocular Deprivation
- ClinicalTrials.gov ID
- NCT02685423
- Acronym / sponsor ID
- LUMA / LUMA_758485
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Lazy Eye, Anisometropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Collaborators
- University of Maryland, College Park, Nova Southeastern University, National Eye Institute (NEI)
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Deprivation - 10 days | Experimental | Behavioral: Binocular deprivation 10 days, Behavioral: Vision training10 days of visual deprivation followed by vision training |
| Vision Training Only | Active comparator | Behavioral: Vision trainingVision training without visual deprivation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binocular deprivation 10 daysAlso: Dark exposure 10 days, Visual deprivation 10 days, Darkness sequestration 10 days, Dark rearing 10 daysResearch participants will be asked to live 10 days in an experimentally-controlled dark environment. | Behavioural | Visual Deprivation - 10 days |
| Vision trainingAlso: Visual therapy, Vision therapy, Visual learning, Perceptual learningSubjects 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. | Behavioural | Vision Training Only, Visual Deprivation - 10 days |
Primary outcome
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.
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.
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.
1 secondary outcome
Binocular motor fusion assessment
Time frame: 3 times during the 2 months before sequestration, 4 times during 12 months after sequestration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
Recruiting
Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
Amblyopia
Recruiting
Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia
Amblyopia, Anisometropic Amblyopia
Recruiting
Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults
Amblyopia, Anisometropic Amblyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin T Backus, PhD principal investigator
Grad Ctr for Vision Research, SUNY College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binocular deprivation 10 days and Vision training in people with Amblyopia, run by State University of New York College of Optometry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.