AmblyopiaNCT02799836
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
A study testing Blindfold in people with Amblyopia and Anisometropia, run by Boston Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Amblyopia, Anisometropia, Visual Impairment
- What is being tested?
- Blindfold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Jun 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia
- Age 18-50 years
Who cannot join
- Strabismus
- Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma,
- Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder
About this study
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.
- Conditions
- Amblyopia, Anisometropia, Visual Impairment
- Being tested
- Blindfold
- Medical subject headings
- Amblyopia, Anisometropia, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlindfoldDevice
Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Light deprived study subjects | Experimental | Study subjects who are blindfolded for 48 hours Receives: Device: Blindfold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logmar visual acuity
Measured: Measured at 60 minutes after blindfold is removed
Logmar visual acuity
Measured: Measured at one week after blindfold is removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start1 Aug 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Jun 2020
Why it stopped: This study never started, did not receive IRB approval and was closed administratively at the site. Therefore, no subjects were recruited or enrolled.
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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Kazlas, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799836
- Sponsor's protocol ID
- P00008306
- Status last verified
- Jul 2020
- First submitted
- 18 Feb 2016
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study subject's visual acuity before and after the intervention will be given to the study subject.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
- ClinicalTrials.gov ID
- NCT02799836
- Acronym / sponsor ID
- P00008306
- Conditions
- Amblyopia, Anisometropia, Visual Impairment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study never started, did not receive IRB approval and was closed administratively at the site. Therefore, no subjects were recruited or enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 15 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light deprived study subjects | Experimental | Device: BlindfoldStudy subjects who are blindfolded for 48 hours |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia
- Age 18-50 years
Key exclusion criteria (3 listed)
- Strabismus
- Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma,
- Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder
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 |
|---|---|---|
| BlindfoldStudy subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours. | Device | Light deprived study subjects |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Yes. Study subject's visual acuity before and after the intervention will be given to the study subject.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blindfold in people with Amblyopia and Anisometropia, run by Boston Children's Hospital.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Logmar visual acuity (time frame: Measured at 60 minutes after blindfold is removed). The study lists 2 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 4 Aug 2020.