AmblyopiaI-BiT PlusNCT02810847
The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years
A study testing I-Bit plus in people with Amblyopia and Strabismus, run by Nottingham University Hospitals NHS Trust.
Trial summary
Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally normal but the vision fails to develop correctly. Around half of these children also have a squint (strabismus) where each eye has a different direction of gaze. Read more about this study
- Who is it for?
- Ages 42 months to 9 years
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- I-Bit plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- 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 42 months to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child must be aged between 3 years 6 months and 9 years 11 months (upper limit is one day before their 10th birthday on day of consent.)
- Visual acuity difference of at least 0.3 log units, with the amblyopic eye being 0.3 logMAR or worse.
- Must have undergone a minimum of 12 weeks refractive adaptation.
- Those in group one must not have had patching or penalisation at all previously but the other two groups' participants may have had previous occlusion.
- Must not have had previous strabismus surgery (for groups one and two, and for group three, they must start the treatment within 4 weeks of having surgery.
- Must be able to use the I-BiT plus system.
Who cannot join
- Stimulus deprivation amblyopia.
- Other ocular or neurological disease affecting the visual system (including Down's syndrome, developmental delay,Craniofacial syndrome,Foetal Alcohol Syndrome, and cerebral palsy among other conditions).
- Photosensitive epilepsy.
- Parent, guardian or child not prepared to give consent.
Trial locations and contacts
No sites are listed yet.
About this study
Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally normal but the vision fails to develop correctly. Around half of these children also have a squint (strabismus) where each eye has a different direction of gaze. This condition is the commonest cause of visual impairment in one eye in children.
This is a randomised control trial of wearing glasses alone (which will result in some visual improvement, termed refractive adaptation) and wearing glasses combined with using I-BiT Plus.
The hypothesis is that using I-BiT Plus will result in an improved visual outcome.
Read the detailed description
This study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the games accurately if they are using their lazy eye. The study is funded by the NIHR and will be undertaken as a randomised control trial to compare this against normal computer games and DVD viewing combined with continuing refractive adaptation (a process that is known to occur for up to 30 weeks). Patients will receive 6 weeks of treatment (recommended 30 mins minimum of play time per day for 6 weeks in the treatment arm) and level of vision will be assessed after 6 weeks and the visual improvement (they will be wearing glasses and also undergoing refractive adaptation) compared with the control. Patients will return to standard care after the trial period which, at 6 weeks, should not affect the final visual outcome in a negative way. The participants will be recruited from patients currently attending one of the 4 trial sites and will have a diagnosis of amblyopia, and be aged between 3 years 6 months and 9 years 11 months. Current treatments for amblyopia include wearing an eye patch over the good eye for up to 6 hours per day, or using eye drops to blur the image in the good eye for periods of 4 weeks at a time. The aim is both to avoid the need for patching or penalisation (which are unpopular treatments) and to get an improved visual outcome.
Assessment study: A study on 62 patients where the investigators will compare the visual acuity, angle of strabismus, stereoacuity and depth of suppression as estimated by I-BiT against measurements made at orthoptic assessment. This data will help interpret the results of the randomised controlled trial and help direct future development.
- Conditions
- Amblyopia, Strabismus
- Being tested
- I-Bit plus
- Keywords
- Amblyopia, strabismus, virtual reality, computer games
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-Bit plusDevice
The study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the game accurately if they are using their lazy eye.
| Study group | Role | What they receive |
|---|---|---|
| I-BiT Plus | Experimental | 6 weeks of I-Bit treatment plus (at least 30 mins/day, 6 days/week) Receives: Device: I-Bit plus |
| Control | No intervention | Refractive adaption or observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group.
Measured: 6 weeks
Secondary outcomes (17)
Successful delivery and installation of equipment to patients' homes, and any reasons for failure
Measured: 10 weeks
The ability of the patients to use the equipment in their home (unsupervised) setting and any reasons why not. Ocular alignment Stereoacuity Proportion of patients completing course
Measured: 10 weeks
The time taken by the patients to use the equipment in their home (unsupervised) setting.
Measured: 10 weeks
The robustness of the equipment by measuring failure / breakage rate.
Measured: 10 weeks
Completeness of outcome measures will be assessed via the frequency of missing data.
Measured: 10 weeks
The recruitment rate and reasons for not taking part.
Measured: 10 weeks
The retention rate and reasons for drop out.
Measured: 10 weeks
Any problems encountered with the randomisation process.
Measured: 10 weeks
The standard deviation in visual acuity at 6 weeks; this will inform sample size calculations for a future trial to assess effectiveness of the I-BiT™ system.
Measured: 6 weeks
Change in visual acuity in the amblyopic eye from baseline to weeks 3 and 10 post randomisation between the two arms.
Measured: 8 Weeks
Change in stereoacuity from baseline to week 3 post randomisation between the two arms.
Measured: 3 weeks
Change in stereoacuity from week 3 to weeks 6 and 10 for the I-BiT treated groups.
Measured: 8 Weeks
Change in binocular status and ocular alignment from baseline to week 6 post randomisation between the two arms in each group.
Measured: 6 Weeks
Change in binocular status and ocular alignment from week 6 to week 10 for the I-BiT treated groups.
Measured: 5 weeks
Quality of life questionnaire at week 6.
Measured: 6 weeks
Proportion of patients completing course of treatment (defined as minimum of 18 hours in total, which equates to 30 minutes per day 6 days per week for six weeks).
Measured: 18 hours
The change in visual acuity, and angle of strabismus between weeks 3, 6 and 10 for the I-BiT treated groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Alexander JE Foss, DM FRCOphth MRCP, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810847
- Sponsor's protocol ID
- 13OY006
- Acronym
- I-BiT Plus
- Status last verified
- Jun 2016
- First submitted
- 26 Apr 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Brown R, Blanchfield P, Fakis A, McGraw P, Foss AJE; I-BiT Study Group. Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5-12 years: a randomised controlled trial. Trials. 2019 Jul 16;20(1):437. doi: 10.1186/s13063-019-3523-0.
PubMed 31311577
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years
- ClinicalTrials.gov ID
- NCT02810847
- Acronym / sponsor ID
- I-BiT Plus / 13OY006
- Conditions
- Amblyopia, Strabismus
- Keywords
- Amblyopia, strabismus, virtual reality, computer games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Wellcome Trust
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 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.
Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally normal but the vision fails to develop correctly. Around half of these children also have a squint (strabismus) where each eye has a different direction of gaze. This condition is the commonest cause of visual impairment in one eye in children.
This is a randomised control trial of wearing glasses alone (which will result in some visual improvement, termed refractive adaptation) and wearing glasses combined with using I-BiT Plus.
The hypothesis is that using I-BiT Plus will result in an improved visual outcome.
Detailed description
This study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the games accurately if they are using their lazy eye. The study is funded by the NIHR and will be undertaken as a randomised control trial to compare this against normal computer games and DVD viewing combined with continuing refractive adaptation (a process that is known to occur for up to 30 weeks). Patients will receive 6 weeks of treatment (recommended 30 mins minimum of play time per day for 6 weeks in the treatment arm) and level of vision will be assessed after 6 weeks and the visual improvement (they will be wearing glasses and also undergoing refractive adaptation) compared with the control. Patients will return to standard care after the trial period which, at 6 weeks, should not affect the final visual outcome in a negative way. The participants will be recruited from patients currently attending one of the 4 trial sites and will have a diagnosis of amblyopia, and be aged between 3 years 6 months and 9 years 11 months. Current treatments for amblyopia include wearing an eye patch over the good eye for up to 6 hours per day, or using eye drops to blur the image in the good eye for periods of 4 weeks at a time. The aim is both to avoid the need for patching or penalisation (which are unpopular treatments) and to get an improved visual outcome.
Assessment study: A study on 62 patients where the investigators will compare the visual acuity, angle of strabismus, stereoacuity and depth of suppression as estimated by I-BiT against measurements made at orthoptic assessment. This data will help interpret the results of the randomised controlled trial and help direct future development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-BiT Plus | Experimental | Device: I-Bit plus6 weeks of I-Bit treatment plus (at least 30 mins/day, 6 days/week) |
| Control | No intervention | –Refractive adaption or observation |
Who may qualify
- Ages
- 42 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The child must be aged between 3 years 6 months and 9 years 11 months (upper limit is one day before their 10th birthday on day of consent.)
- Visual acuity difference of at least 0.3 log units, with the amblyopic eye being 0.3 logMAR or worse.
- Must have undergone a minimum of 12 weeks refractive adaptation.
- Those in group one must not have had patching or penalisation at all previously but the other two groups' participants may have had previous occlusion.
- Must not have had previous strabismus surgery (for groups one and two, and for group three, they must start the treatment within 4 weeks of having surgery.
Key exclusion criteria (4 listed)
- Stimulus deprivation amblyopia.
- Other ocular or neurological disease affecting the visual system (including Down's syndrome, developmental delay,Craniofacial syndrome,Foetal Alcohol Syndrome, and cerebral palsy among other conditions).
- Photosensitive epilepsy.
- Parent, guardian or child not prepared to give consent.
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 |
|---|---|---|
| I-Bit plusThe study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the game accurately if they are using their lazy eye. | Device | I-BiT Plus |
Primary outcome
The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group.
Time frame: 6 weeks
17 secondary outcomes
Successful delivery and installation of equipment to patients' homes, and any reasons for failure
Time frame: 10 weeks
The ability of the patients to use the equipment in their home (unsupervised) setting and any reasons why not. Ocular alignment Stereoacuity Proportion of patients completing course
Time frame: 10 weeks
The time taken by the patients to use the equipment in their home (unsupervised) setting.
Time frame: 10 weeks
The robustness of the equipment by measuring failure / breakage rate.
Time frame: 10 weeks
Completeness of outcome measures will be assessed via the frequency of missing data.
Time frame: 10 weeks
The recruitment rate and reasons for not taking part.
Time frame: 10 weeks
The retention rate and reasons for drop out.
Time frame: 10 weeks
Any problems encountered with the randomisation process.
Time frame: 10 weeks
The standard deviation in visual acuity at 6 weeks; this will inform sample size calculations for a future trial to assess effectiveness of the I-BiT™ system.
Time frame: 6 weeks
Change in visual acuity in the amblyopic eye from baseline to weeks 3 and 10 post randomisation between the two arms.
Time frame: 8 Weeks
Change in stereoacuity from baseline to week 3 post randomisation between the two arms.
Time frame: 3 weeks
Change in stereoacuity from week 3 to weeks 6 and 10 for the I-BiT treated groups.
Time frame: 8 Weeks
Change in binocular status and ocular alignment from baseline to week 6 post randomisation between the two arms in each group.
Time frame: 6 Weeks
Change in binocular status and ocular alignment from week 6 to week 10 for the I-BiT treated groups.
Time frame: 5 weeks
Quality of life questionnaire at week 6.
Time frame: 6 weeks
Proportion of patients completing course of treatment (defined as minimum of 18 hours in total, which equates to 30 minutes per day 6 days per week for six weeks).
Time frame: 18 hours
The change in visual acuity, and angle of strabismus between weeks 3, 6 and 10 for the I-BiT treated groups.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Derived from this study: PubMed 31311577Brown R, Blanchfield P, Fakis A, McGraw P, Foss AJE; I-BiT Study Group. Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5-12 years: a randomised controlled trial. Trials. 2019 Jul 16;20(1):437. doi: 10.1186/s13063-019-3523-0.
- Individual participant dataSharing planned: Undecided
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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.
Alexander JE Foss, DM FRCOphth MRCP principal investigator
Nottingham University Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing I-Bit plus in people with Amblyopia and Strabismus, run by Nottingham University Hospitals NHS Trust.
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 6 inclusion and 4 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 23 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Brown (0115 9249924 ext. 67150, Rebecca.brown4@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810847, which also lists 1 linked publication.
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 23 Jun 2016.