The effect of oral steroid therapy on intra-ocular pressure
Research type
Research Study
Full title
Pilot study to examine the effect of oral corticosteroids on intraocular pressure in children with malignancy.
IRAS ID
265599
Contact name
Juliet Gray
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Childhood acute lymphoblastic leukaemia (ALL) has achieved excellent cure rates in the past 20 years. The use of corticosteroids are a key component of this successful treatment strategy. The UK strategy has moved towards the use of dexamethasone rather than prednisolone as the steroid of choice in treatment for ALL in the UKALL2003 and current UKALL2011 trial.
Systemic corticosteroid use is not without side effects. Early and late side effects are well recognised and include muscle pain and weakness, infections, high glucose levels, behavioural problems and imbalance of hormones.
However, the occurrence of acute glaucoma (high pressure within the eye) during induction therapy has only been reported rarely.
In the course of UKALL2011 in Southampton there have been two patients of note that had a significant rise in intraocular pressure (IOP). One had a very high rise in eye pressure in one eye, with symptoms of eye pain and blurring of vision. As yet unknown are whether there are less severe IOP rises that are clinically significant in other patients, but in whom the patients have no symptoms. Furthermore high dose dexamethasone may induce IOP rises in the treatment of other childhood cancers. A recent audit of the paediatric oncology unit in Southampton revealed approximately 40% of our children are treated with systemic corticosteroids.
This is an observational study of children receiving corticosteroids as part of chemotherapy for paediatric malignancies. We aim to establish the incidence and extent of IOP rise in children receiving corticosteroids.
All children that are receiving corticosteroids as part of their oncology treatment at Southampton General Hospital will be eligible for this study. We will measure their intraocular pressure using a non- invasive, NICE approved technique.Lay Summary of Results
Only 18 (out of planned 90) patients recruited because of COVID related issues allowing initial student to pursue project. Subsequent recruitment limited by lack of student attached to project/staffing.The study was conducted in patients with cancer who were receiving steroid medicine as part of their chemotherapy or as anti-sickness medicine. Paired intraocular pressure readings obtained on 9 of19 patients prior to and after receiving steroids. 7 of 9 patients experienced a rise in eye pressure, 3 of these needed further follow up. None of these patients had any eye symptoms.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0572
Date of REC Opinion
20 Sep 2019
REC opinion
Favourable Opinion