Your impact 2023

Making sense of functional testing

Your support has enabled scientific testing of a new functional assessment tool, which will be used to evaluate the real-world effectiveness of new treatments and devices for people with vision loss.


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When a person has been living with vision loss for many years, they often rely on their other senses to navigate the world around them.

This creates an additional challenge for researchers when they are conducting functional testing which assesses whether a new treatment or devices being tested in a clinical study is making a difference for patients.

“We need to be certain that an intervention which works in the lab or clinic can also make a difference in the real world and is having a real effect,’’ says Lisa Lombardi from the Bionic Eye Unit.

“People living with vision loss become very good at using their other senses – like their hearing, touch or their residual vision – to navigate and get a sense of where they are.

“So if we are assessing how much a new intervention – whether it be a drug or a device – is improving a patient’s ability to navigate a situation, we need to understand how much of this is the result of the intervention and how much is influenced by their other senses.’’

The Bionic Eye team and colleagues in CERA’s Retinal Gene Therapy Unit frequently conduct functional assessment with clinical trial participants who have lived with profound vision loss.

These tests can include things like assessing their outdoor navigation, whether they can complete everyday tasks like emptying bins and heating food in the microwave, if they can tell whether a light is on, navigate a space – or how to locate other people in a social setting.

While the current testing methods – used by many researchers around the world – are effective, they rely heavily on assessing a participant’s visual ability alone.

Lombardi and her team are developing a new assessment tool which also observes in detail how participants use their other senses to complete tasks.

She says a more detailed assessment tool would provide a more accurate picture for researchers about how interventions make a difference for patients.

CERA’s researchers have collaborated with participants from the Bionic Eye clinical trial, through one-on-one interviews and a focus group, to develop the new assessment tool.

However, before it can be used in research it must be scientifically validated. This means it needs to be tested repeatedly to ensure it gives reliable and accurate results.

As part of this process, researchers will observe how two experienced orientation and mobility specialists and two researchers use the assessment tool and analyse their results.

The research will be conducted with philanthropic funds donated by CERA’s generous supporters.

Lombardi says that as well as being used in research – the tool could also become a standard assessment used by orientation and mobility specialists to determine the effect of training programs for people living with low vision.

“We are extremely grateful for the philanthropic support we have received which will play an essential role in getting this new tool up and running,’’ says Lombardi.

“Armed with better data about the effect of new treatments on everyday life, our hope is that we can make new technologies available to people living with vision impairment.’’

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