Information for health professionals regarding current research and patient recruitment
We first described the use of modified virtual reality technology for the treatment of amblyopia in 2006 (1) and the early results by us (2), and others using our system (3), were encouraging. This lead to a translational funding award from the Wellcome Trust which allowed a complete system redesign.
Pilot Study – Stage I
The first stage of the project (April 2010 – March 2011) consisted of developing the new software and hardware systems. During this phase we recruited a small number of patients to conduct a feasibility study. This showed that patients gained on average 0.19 logMAR vision with only three hours treatment spread over six weeks. These results have been published (4).
Clinical Trial – Stage II
During the second stage (June 2012 – December 2013) we conducted a randomised controlled trial using the I-BiT system and comparing study and control groups and the full protocol has been published (5).
The centres involved in this trial were Nottingham University Hospitals and Addenbrookes Hospital, Cambridge.
Treatment consisted of watching either DVDs or playing computer games for approximately 30 minutes on a weekly basis for six weeks.
This trial has now been completedand the results have been published (6).
I_BiT Plus (Current Trial 2016)
On the basis of these trial results, we have received a large grant from i4i (NIHR) in order to undertake a further redesign of our system, both hardware and software, and to adapt this for home use. The work for this is now complete and we will begin recruitment for the next clinical trial before the end of this year (2016).
We also have had funding from the Wellcome Trust to be able to explore what is the optimal patient group to be treated.
Patients who fulfill the inclusion criteria (based on age, level of VA, difference in VA and previous treatment history, as well as diagnosis) will be assigned to a treatment group based on their type of amblyopia (1 - previously untreated anisometropic amblyopia, 2 - strabismic or mixed amblyopia, may have had occlusion in the past but no previous surgery and 3 - immediately post-operative (strabismus surgery) strabismic or mixed amblyopia). Patients will then be randomised into the treatment or control arm and receive treatment (or placebo) at home for 6 weeks. The patients will not be masked as to the intervention but the clinician carrying out the assessments will be. Patients will be assessed in clinic at intervals during the 6 weeks.
We will start recruiting for the next trial towards the end of 2016 and this will continue for approx 12 months. We will be recruiting current patients from 4 centres across the country; in Nottingham, Cambridge, Stoke-On-Trent and London (Moorfields). Local contact details are available on the Contact Us page.