The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years

NCT02810847 | Unknown

• 1 other identifier: 13OY006
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Amblyopia; Strabismus

Keywords

Amblyopia; strabismus; virtual reality; computer games

Outcome Measures

Primary Outcomes (1)

• The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group.

  6 weeks

Secondary Outcomes (17)

• Successful delivery and installation of equipment to patients' homes, and any reasons for failure

  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

  10 weeks

• The time taken by the patients to use the equipment in their home (unsupervised) setting.

  10 weeks

• The robustness of the equipment by measuring failure / breakage rate.

  10 weeks

• Completeness of outcome measures will be assessed via the frequency of missing data.

  10 weeks

Study Arms (2)

I-BiT Plus

EXPERIMENTAL

6 weeks of I-Bit treatment plus (at least 30 mins/day, 6 days/week)

Device: I-Bit plus

Control

NO INTERVENTION

Refractive adaption or observation

Interventions

I-Bit plus DEVICE

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.

I-BiT Plus

Eligibility Criteria

• Age: 42 Months - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Wellcome Trust: collaborator

Related Publications (1)

• 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.

  PMID: 31311577 DERIVED

MeSH Terms

Conditions

Amblyopia; Strabismus

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; Ocular Motility Disorders; Cranial Nerve Diseases

Study Officials

• Alexander JE Foss, DM FRCOphth MRCP

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Brown

CONTACT

0115 9249924; Rebecca.brown4@nuh.nhs.uk

Natalie McGregor, PhD

CONTACT

01159709049; researchsponsor@nuh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: June 23, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 23, 2016

Record last verified: 2016-06