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EuroTimes 11-7 new 1 3/7/06 2:26 pm Page 7 Special Focus New risk calculator helps physicians assess risk for glaucoma Robert Weinreb Dermot McGrath in Sao Paulo A NEW tool designed to help assess the risk of glaucoma in patients with ocular hypertension and assist physicians in deciding the best treatment strategy for such patients was unveiled at the World Congress of Ophthalmology. The electronic risk calculator, developed by Robert Weinreb MD and Felipe A Medeiros MD, glaucoma specialists at the Hamilton Glaucoma Center at the University of California, San Diego, US, represents the latest advancement in an ongoing effort to create and introduce predictive tools in ophthalmic medicine. “The risk calculator helps to identify patients with ocular hypertension who are at high risk of developing glaucoma and who may benefit from treatment, as well as those who are at low risk who may not need treatment. It will allow doctors to assess patient risk levels and, if needed, recommend treatment options that can help avert possible progression to glaucoma,” said Dr Weinreb, director of the Hamilton Glaucoma Center and distinguished professor of ophthalmology at the University of California, San Diego, US. “The risk calculator helps to identify patients with ocular hypertension who are at high risk of developing glaucoma and who may benefit from treatment, as well as those who are at low risk who may not need treatment” Robert Weinreb MD Patients with ocular hypertension may have multiple risk factors – such as age, elevated intraocular pressure, thinner central cornea, and so forth – for progression to glaucoma, said Dr Weinreb. A collective assessment of these risk factors can help clinicians identify those patients with elevated eye pressure who are more likely to progress to glaucoma and may benefit from early treatment. It can also identify those that are at low risk for progression to glaucoma who may not need treatment. He said that similar predictive models have been developed for other therapeutic areas, in particular the Framingham Study initiated in the 1950s, which provided the basis for cardiac risk assessment. “We asked ourselves how this type of therapeutic model could be applied to glaucoma. What we wanted to achieve was to be able to identify patients who were at moderate to high risk for conversion from ocular hypertension to glaucoma, as well as those who were at low risk,” said Dr Weinreb. He noted that hitherto there has been no systematic approach for physicians to decide whether or not to treat patients with ocular hypertension. “Some doctors treated all patients with high IOP and others treated very few patients. Risk assessment not only allows us to treat those patients who are at highest risk but also to observe those patients who are at lowest risk. In other words, it allows physicians to focus their resources and allocate their care to those patients who are most in need,” he said. Incorporating OHTS findings Dr Weinreb explained that the calculator incorporates findings from the Ocular Hypertension Treatment Study (OHTS) conducted in the US by the National Eye Institute, which identified key patient risk factors predictive of disease progression from ocular hypertension to glaucoma. In that multicentre study, half of 1,636 patients with high IOP were randomly selected for treatment to lower their IOP and half were randomly selected for observation alone. All patients had no optic nerve damage or visual field defects at the time of their enrolment into the study. After five years’ follow-up, 9.5% of patients who were not treated progressed to glaucoma, while 4.4% of the treated group progressed to glaucoma in the same time period. Dr Weinreb said that OHTS identified the following factors as being associated with an increased risk of developing glaucoma: older age, elevated IOP, thinner central corneal thickness, increased vertical cup/disc ratio and greater pattern standard deviation. Using the risk calculator, physicians can assess these six risk factors and insert their findings at various points on the calculator. When taken in combination, these factors help determine the risk of conversion from ocular hypertension to glaucoma within the next five years by using a simple points system. Validated in population study The steps in the development and validation of the risk calculator have been described in detail in an article by Dr Medeiros, Dr Weinreb and colleagues published in Archives of Ophthalmology (Medeiros FA, Weinreb RN, et al. Arch Ophthalmol 2005; 123:1351-60). Dr Medeiros said that the risk calculator was validated in an independent population as part of the National Eye Institute's sponsored Diagnostic Innovations in Glaucoma Study (DIGS) at the Hamilton Glaucoma Center of the University of California, San Diego, which included 252 eyes of 126 patients with untreated ocular hypertension. “We evaluated the risk for glaucoma development for each patient at the beginning of the study and we tried to establish if the patients at higher risk at baseline according to the risk calculator were actually the ones who went on to develop glaucoma. The results showed a good correspondence between the risk predicted by the model and what was observed during the follow-up of these patients,” said Dr Medeiros. Dr Medeiros said that the next step was to try to determine if an estimate of moderate to high risk as defined by the calculator was in fact sufficient to indicate treatment for these patients. “Although the OHTS study provides us with good evidence regarding the rates of conversion to glaucoma, we still lack reliable studies about the rate of progression from ocular hypertension to functional deficit and blindness. Some retrospective studies estimate that between 1.5% and 11% of patients with ocular hypertension will progress to blindness,” he said. “Although the OHTS study provides us with good evidence regarding the rates of conversion to glaucoma, we still lack reliable studies about the rate of progression from ocular hypertension to functional deficit and blindness” guidelines regarding the appropriate thresholds for treatment. Patients deemed to be low risk (ie with an estimate of progression to glaucoma of less than 5%) should be monitored; those considered at moderate risk (5%-15%) may receive treatment depending on the final judgement of the physician; and those at high risk should generally receive treatment, he said. “Along with the risk assessment provided by the calculator there are several other factors that need to be taken into account when deciding the treatment strategy, such as the patient’s overall health status, life expectancy and commitment to treatment” Dr Medeiros emphasised that the risk calculator should be used as an adjunct to, and not as a substitute for, clinical experience and judgment. “Each physician is likely to have his or her own threshold for treatment. Along with the risk assessment provided by the calculator there are several other factors that need to be taken into account when deciding the treatment strategy, such as the patient’s overall health status, life expectancy and commitment to treatment, as well as side effects from medication and costs. They all should be weighed to provide effective management of these patients,” he said. The glaucoma risk calculator was supported in part by an independent research grant from Pfizer, Inc, and is distributed free of charge to interested ophthalmologists. [email protected] [email protected] Felipe A Medeiros MD Dr Medeiros said that while the benefits of treatment have been well established by the OHTS study, it is also important to determine when the benefits of treatment outweighed the risks. He noted that a panel of experts recently proposed 7