The association between patterns of glucocorticoid therapy and risk of developing cataracts and glaucoma in adults.

Study type
Protocol
Date of Approval
Study reference ID
16_211
Lay Summary

Glucocorticoids (commonly known as steroids) are used to treat various inflammatory conditions. They are a useful treatment because they quickly reduce inflammation, and its associated symptoms. However, there are many side effects associated with their use, including cataracts and glaucoma that affect the eyes.

Doctors’ guidelines recommend discussing with patients the benefits and harms at the start of glucocorticoid treatment. However, it is currently not possible to accurately calculate this risk since it is unknown how commonly cataract and glaucoma occur in relation to glucocorticoid treatment for different diseases. Furthermore, it is not known what dose or duration of glucocorticoids leads to cataracts and glaucoma, whether a ‘safe dose’ exists, when the risk occurs with relation to treatment recency or how the risk declines after stopping treatment. This research aims to answer these questions within five inflammatory conditions for which glucocorticoids are commonly prescribed: rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and inflammatory skin disease. The risk of cataracts and glaucoma will be calculated and compared between those who are treated with glucocorticoids and those who are not. The risk estimate can then be used to help patients and doctors make informed decisions when treating with glucocorticoids.

Technical Summary

Glucocorticoids (GCs) have had a prominent role in the treatment of inflammatory conditions for over 60 years. They are effective anti-inflammatory agents, but are associated with many potential adverse effects, including cataract and glaucoma. The risk of developing cataract/glaucoma associated with GCs has not been well quantified. The aim of this study is to quantify this risk, in the context of different doses, duration and recency of treatment. The incidence of cataract/glaucoma in 5 different inflammatory conditions (rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and inflammatory skin disease) will be compared amongst those exposed and unexposed to GCs. Different conventional models of drug exposure will be applied, including ‘on drug’, ‘on drug plus lag window of risk’ (windows of risk are 1 months, 3 months, 6 months and 1 year) and ‘ever exposed’ (1). Dose and time specific models will also be considered including dose on the day of the event, average dose within pre-specified time windows (see above), cumulative dose in pre-specified time windows and the number of years on GCs within the study period. Further, weighted cumulative dose models (2) will also be developed and tested against more conventional models.

Collaborators

William Dixon - Chief Investigator - University of Manchester
Rachel Black - Corresponding Applicant - University of Manchester
Jamie Sergeant - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of Manchester

Linkages

HES Admitted Patient Care