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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02810847
Other study ID # 13OY006
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 26, 2016
Last updated June 20, 2016
Start date June 2016
Est. completion date December 2017

Study information

Verified date June 2016
Source Nottingham University Hospitals NHS Trust
Contact Rebecca Brown
Phone 0115 9249924
Email Rebecca.brown4@nuh.nhs.uk
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 182
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 42 Months to 9 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
I-Bit plus
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust National Institute for Health Research, United Kingdom, Wellcome Trust

Outcome

Type Measure Description Time frame Safety issue
Primary The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. 6 weeks No
Secondary Successful delivery and installation of equipment to patients' homes, and any reasons for failure 10 weeks No
Secondary 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 No
Secondary The time taken by the patients to use the equipment in their home (unsupervised) setting. 10 weeks No
Secondary The robustness of the equipment by measuring failure / breakage rate. 10 weeks No
Secondary Completeness of outcome measures will be assessed via the frequency of missing data. 10 weeks No
Secondary The recruitment rate and reasons for not taking part. 10 weeks No
Secondary The retention rate and reasons for drop out. 10 weeks No
Secondary Any problems encountered with the randomisation process. 10 weeks No
Secondary 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. 6 weeks No
Secondary Change in visual acuity in the amblyopic eye from baseline to weeks 3 and 10 post randomisation between the two arms. 8 Weeks No
Secondary Change in stereoacuity from baseline to week 3 post randomisation between the two arms. 3 weeks No
Secondary Change in stereoacuity from week 3 to weeks 6 and 10 for the I-BiT treated groups. 8 Weeks No
Secondary Change in binocular status and ocular alignment from baseline to week 6 post randomisation between the two arms in each group. 6 Weeks No
Secondary Change in binocular status and ocular alignment from week 6 to week 10 for the I-BiT treated groups. 5 weeks No
Secondary Quality of life questionnaire at week 6. 6 weeks No
Secondary 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). 18 hours No
Secondary The change in visual acuity, and angle of strabismus between weeks 3, 6 and 10 for the I-BiT treated groups. 8 weeks No
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