Surgical glaucoma as a subspeciality is undergoing significant change. Most of this has been driven by new devices introduced to market with the hope of trying to improve patient safety while still achieving adequate intraocular pressure (IOP) reductions.
New technologies invariably take time to mature, and some will be proven over time to have superior safety, efficacy, or value in particular patient populations. Unless there is a systemic process for evaluating outcomes, there is the potential that patients are not receiving the best possible available care.
“There is now ample evidence to show that outcomes in the ‘real world’ are generally not as good as that shown in clinical trials.”
Randomised controlled trials (RCTs) provide high level evidence of outcomes in a highly controlled environment: a tightly controlled patient population, with a relatively small group of experienced surgeons. In addition, the high cost of clinical trials means that the follow up window is usually short relative to an individual patient’s journey with glaucoma. While RCTs provide the gold standard of what is achievable under such controlled conditions, there is now ample evidence to show that outcomes in the “real world” are generally not as good as that shown in clinical trials.
In contrast, registries usually do not exclude any patients from data collection, and they are very cost effective for providing longer term outcomes than clinical trials can usually provide. They therefore provide additional information as to how different treatments perform in a real-world patient population, as opposed to the highly controlled environment of a clinical study.
Fight Glaucoma Blindness! (FGB) is one such registry that we, at the Save Sight Institute, set up to follow the outcomes of a range of glaucoma surgeries. Many surgeons are interested in auditing their outcomes to see whether they are doing a good job. We made this task easier by developing a web-based application to easily capture the data and provide an in-built statistical analysis that allows comparison of results with other surgeons.
On top of this audit role, the aggregated data is then available for publication of large data sets. Currently, FGB is tracking more than 2,500 iStent inject surgeries, 600 Xen implants, as well as large numbers of more traditional glaucoma surgery like trabeculectomies and tube shunt surgeries.
As new technologies are released to market, such data gives an excellent opportunity to compare safety and efficacy outcomes with more established technologies. The importance of this is unscored by the CyPass experience where a minimally invasive glaucoma surgery (MIGS) device was withdrawn from market because of safety concerns that only became evident after five years of follow up.
One of the biggest limitations in being able to scale registry data is the ongoing requirement for data entry. Minimising data entry was at the forefront when designing FGB and its sister registries, but it remains a significant barrier to scale. The Save Sight Registries group is actively involved in integrating the registries with electronic medical records. The ultimate goal is single point data entry, where data entered in the electronic medical record is automatically populated into the registry software.
Our data is maturing to the point where we can now provide clinicians with a good understanding of what outcomes they can achieve in different patient populations with different surgeries. As we scale the project, we hope to incorporate audit of outcomes as part of routine clinical practice. Such a tool provides rapid feedback to clinicians as to how particular surgeries are performing and help select the best possible procedure for each individual patient.
Save Sight Registry modules track outcomes in a number of different subspecialty areas, and the platform allows audit of outcomes at no cost to the user. For more information or to request access for the glaucoma, retina, corneal or any other module, visit: savesightregistries.org
About the author
Name: Associate Professor Mitchell Lawlor
Qualifications: BMed MMed FRANZCO PhD
Affiliations: Save Sight Institute
Location: Sydney
Years in industry: 8
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