The World Health Organisation defines a clinical trial as “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes”. Clinical trials are integral for finding new and improved ways to treat, prevent or diagnose different types of illnesses.
If we all opened our medicine cabinets, every drug would have undergone testing in a clinical trial at some point. It is through testing in clinical trials that it is determined whether there are any side effects to these drugs, whether they’re effective for the condition they are targeting and if they are ultimately safe for administration.
The world of clinical trials and, more specifically, the wonderful world of ophthalmic clinical trials is a field that I knew very little about until in 2019. As part of my clinical placement in the final year of my orthoptics degree, I spent some time in the clinical trials department of the Lions Eye Institute (LEI) in Perth. My time as a LEI student inspired me to make the move from Melbourne to Perth in late 2019 to begin my career as an orthoptist.
When I started in the LEI’s clinical trials department I was greeted by a friendly team consisting of clinical trial co-ordinators, clinical trials assistants, ophthalmologists and orthoptists. I was one of three orthoptists and the team has since grown to include a total of five orthoptists, as well as a phlebotomist and a research nurse.
LEI’s clinical trials department is involved in multiple kinds of trials; from natural history studies, to pharmaceutical sponsored studies, to investigator initiated trials and external clinical trials. The role of an orthoptist in these trials varies from conducting assessments such as imaging of the eye or testing best corrected visual acuity, to co-ordinating patient visits and the maintenance and calibration of equipment.
Many of the clinical trials at LEI are multi-centre clinical trials, meaning that at the same time a trial is being run at our site here in Perth, the same clinical trial is being conducted in various sites across the world. To ensure the data we are collecting is comparable to that being collected at other sites, protocols and assessment specific manuals dictate the way we conduct our assessments for these trials.
Some of these manuals, especially the ones for different imaging modalities, can be lengthy but they specify exactly how these images need to be captured, labelled, saved and exported to the imaging reading centres. Some of the imaging modalities that studies require include anterior segment photography, retinal photography using both wide-field and standard retinal cameras, fluorescein angiography, microperimetry and dark adaptometry – to name a few.
As clinical trials orthoptists at LEI we also hold a unique role in non-ophthalmic clinical trials; these can be trials for conditions like cystic fibrosis, kidney disease or various cancers. Often the investigational products being used in these trials, although not targeted for an eye condition, can have side effects in the eye. Alongside a designated ophthalmologist and sometimes an optometrist for each trial, our role as an orthoptist is to provide a thorough eye assessment for the patient and report this back to the site running the clinical trial in a timely and succinct manner.
In the pre-trial process for these trials, we orthoptists are consulted on whether conducting the sponsor requested assessments are feasible in our clinical setting, and whether we think any other assessments are clinically indicated. When we begin to see these patients once they are on study, we then play an integral role in explaining what their time on the study will entail from an ophthalmological point of view. Often these patients have only ever been to a primary healthcare provider for their eyes and don’t have any ocular problems apart from simple refractive errors. Understandably, these patients are sometimes anxious about the changes that may occur with their eyes and eyesight.
Our clinical understanding as orthoptists enables us to explain these changes to patients and answer any questions they may have.
Some of the new and innovative ideas being explored currently across the globe in ophthalmic clinical trials range from topical therapy for cystoid macular oedema, to a port delivery system that dispenses ranibizumab continuously into the eye over a period of months. There are also conversations beginning around the expiration of patents for Eylea and Lucentis in the next few years that may then result in biosimilars. The world of ophthalmic clinical trials is ever changing and there’s always something exciting in the pipeline, so watch this space!
ABOUT THE AUTHOR: Sachinee Jayasuriya has been working as an orthoptist at the Lions Eye Institute and the Perth Children’s Hospital since graduating from La Trobe University in 2019.