Study aims
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*** The SamExo pilot trial is now closed *** *** The Final Report has been submitted *** *** A summary of the results has been written for families who took part (see 'Study Info for Parents' or 'Publications' sections) *** |
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The SamExo study is a pilot or 'rehearsal' randomised controlled trial (RCT) of surgery versus active monitoring in children with intermittent exotropia. The study is running from January 2011 until March 2013, with recruitment between Sept 2011 and June 2012. The main aim of this pilot study is to find out whether enough parents are willing to take part in such a trial without later withdrawing from it. If we find that sufficient numbers of parents are happy to participate then it is hoped that, in the future, a full-scale trial will answer the question of whether or not surgery is more effective than active monitoring for children with this condition. Data collected include routine clinical measurements, quality of life evaluations and measurement of costs, both to the NHS and families. Another aim is to seek parents’ views about their reasons for wanting or not wanting to take part in the trial. Therefore we are carrying out some telephone interviews with parents in the hope that their opinions and ideas will help us to understand more about the sometimes difficult decision-making process involved in managing any childhood condition. This will help inform future studies of intermittent exotropia specifically and surgery in children generally. Additional information about the study including some background research and the study timeframe can be found on the left-hand menu.
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