The technology, developed by scientists from the University of Białystok and the Medical University of Białystok, uses diffusion tensor imaging (DTI) to assess the condition of optic nerve fibres. The method has received a US patent and could eventually be used on standard MRI scanners without the need for hospitals to purchase new equipment.

In an interview with PAP, Łukasz Łabieniec, PhD, from the University of Białystok, and Łukasz Lisowski, PhD, from the Medical University of Białystok, explain how the technology works, why early detection of optic nerve damage is crucial, and what challenges remain before it can reach clinical practice.

PAP: Where did the idea for developing a new method for diagnosing optic nerve damage come from?

Łukasz Łabieniec from the University of Białystok: We started from the limitations of currently used diagnostic methods. Classic MRI provides excellent insight into the anatomy of the brain and eye sockets, but it does not allow to assess the microstructure of the optic nerve fibres. However, this is the level where the first changes leading to vision loss often appear. We wanted to create a tool that would enable detection before irreversible damage occurs.

To achieve this, we used diffusion tensor imaging (DTI), which analyses the movement of water molecules in neural tissue. This enables a much more accurate assessment of the condition of the optic nerve fibres than a classic MRI.

Łukasz Lisowski from the Department of Ophthalmology, Medical University of Białystok: For me, this project also has a very personal dimension. My grandmother lost her sight completely due to glaucoma. The disease was diagnosed too late, and her vision could not be saved. This experience sparked my interest in ophthalmology and optic nerve diseases. I understood the crucial importance of early diagnosis, as vision once lost cannot be regained.

Later, this personal motivation merged with daily clinical practice. Our clinic received patients with optic neuropathies of unclear origin, including those with suspected idiopathic intracranial hypertension. In such cases, treatment decisions can be extremely difficult. Waiting too long can lead to irreversible vision loss, but surgical treatment also carries a risk of complications.

We needed a tool that would enable a more objective assessment of the degree of optic nerve damage, and facilitate therapeutic decision-making. This need led to that the idea for our method.

PAP: What are the advantages of your solution over standard MRI currently used in diagnostics?

Ł.Ł.: Classic MRI is a bit like taking a picture of a cable - you can see its course and whether it has been severed. Our method allows us to assess whether everything inside the cable is functioning properly. This, of course, is a comparison - in reality, we are analysing the movement of water molecules within the optic nerve. Where the fibres are healthy and well-organized, water moves differently than where they have been damaged.

This allows us to obtain information about the microstructure of the optic nerve that standard MRI does not provide. Importantly, this information can be obtained during the same MRI examination, without the administration of contrast and without exposing the patient to additional radiation.

PAP: What information about the condition of the optic nerve can be obtained from diffusion tensor analysis that is not provided by currently used imaging tests?

Ł.Ł.: We can assess whether the damage is primarily to the myelin sheath of the nerve fibres or to the axons themselves, i.e., the fibres that conduct impulses. This is a crucial distinction, as these two types of damage can have different causes and require different diagnostic and therapeutic approaches.

Moreover, such changes may be visible even before the patient notices vision deterioration, and before they become detectable in standard MRI and other ophthalmological tests.

PAP: What clinical significance could there be in being able to detect optic nerve damage not visible in standard MRI?

Ł.L.: If further research confirms the effectiveness of this method, its potential impact could be significant. In practice, patients report deteriorating vision or have abnormal ophthalmological test results, and conventional MRI cannot clarify the cause of these symptoms.

Our method could help fill this gap. In the future, it could facilitate earlier detection of optic nerve damage, more accurate differentiation of the causes of neuropathy, assessment of the disease's progression, and monitoring of treatment effectiveness.

It is important to emphasise, however, that we are currently talking about a solution in the research phase. Its clinical potential is very promising, but it still requires confirmation in larger patient studies.

PAP: For which diseases or patient groups might the new method prove particularly useful?

Ł.L.: We are primarily considering patients with optic neuropathies, especially when standard diagnostics do not provide a clear answer. This applies, among others, to: people with idiopathic intracranial hypertension and patients with tumours or other lesions in the optic nerve, optic chiasm, and distal visual pathways.

Potential applications also include optic neuritis, multiple sclerosis, and other demyelinating diseases. In the future, the technology may also be used in the diagnosis of selected forms of glaucoma, especially those that are atypical or difficult to clearly assess.

The greatest value of this method is the ability to quantitatively assess the microstructure of the optic nerve in situations where physicians currently lack an equally precise diagnostic tool.

PAP: How can the neuropathy index you calculate support physicians in making diagnostic and therapeutic decisions?

Ł.Ł.: Instead of several difficult-to-interpret parameters, we developed a single index expressed as a percentage - the closer to 100%, the healthier the nerve. It can be compared to a battery charge indicator: a full battery indicates a properly functioning nerve, while a decreasing charge level signals progressive damage. This result is simple to interpret and easy to track over time - it allows to assess whether the nerve's condition is deteriorating, remaining stable, or improving in response to treatment.

Ł.L.: From a physician's point of view, the most important thing is that the index is not merely a qualitative description, but a measurable numerical parameter. It can be compared between the right and left optic nerves, analysed for changes in subsequent examinations of the same patient, and in the future also compared to reference values. In clinical practice, it could facilitate the detection of asymmetry, disease progression monitoring, and identifying patients who require more in-depth diagnostics or intensive follow-up.

PAP: Could this method enable the detection of changes at an earlier stage of disease progression than currently used techniques?

Ł.Ł.: This may be its greatest advantage. In many optic nerve diseases - such as ischaemic and post-traumatic neuropathies, demyelinating conditions, including multiple sclerosis, and conditions associated with increased intracranial pressure - damage develops gradually and leads to irreversible loss of nerve fibres. The earlier it is detected, the greater the chance of starting appropriate treatment and preserving visual function. Our method allows to detect subtle changes in the microstructure of the nerve even before they become visible in conventional MRI or ophthalmological examinations.

PAP: Could the new method help in making therapeutic decisions in the future, for example, regarding surgical or pharmacological treatment?

Ł.L.: This is one of the most important directions for the further development of this technology. In daily practice, doctors often make decisions based on incomplete data - they must decide whether observation is sufficient, whether treatment should be accelerated, therapy changed, or the patient qualified for surgery. If the method is proven in further clinical trials, it could become an additional tool supporting these decisions. It would allow to assess whether microstructural damage to the optic nerve has already occurred, whether the changes remain stable, or progress despite treatment, and thus provide the physician with more objective data for treatment planning.

PAP: The university's materials mention two clinical cases of using the newly developed technology. To what extent do the results of these analyses confirm the potential of the method, and what conclusions can be drawn from these experiences?

Ł.Ł.: Both cases clearly demonstrate the possibilities this technology can offer.

The first case concerned a patient with post-traumatic damage to the eyeball. Before the injury, he saw properly, but over time the optic nerve began to atrophy. Classic magnetic resonance imaging did not show any significant changes for a long time, but our method clearly indicated that the nerve microstructure had already been damaged. We developed this technology with situations like this in mind.

The second case was special. It concerned a girl with a tumour located near the optic chiasm. Because she had virtually no vision, removal of the tumour along with optic chiasm was considered. However, the analysis performed using our algorithm showed that at least some of the nerve fibres retained their functional potential. This was information that other tests had not provided.

Based in this, the treatment strategy was changed. Surgeons removed the tumour itself, sparing the visual pathways, and the patient was treated with modern targeted treatment. After several years, she began to regain light perception in one eye. Of course, individual cases do not yet prove the effectiveness of the method, but they show that it can provide information that has a real impact on clinical decisions and patient prognosis.

PAP: To what extent were the results of these analyses surprising from the point of view of the attending physician?

Ł.L.: The most surprising thing was that in both cases we were not dealing with underdiagnosed patients. On the contrary - they underwent full ophthalmological and imaging diagnostics, and yet questions remained that the available methods did not provide a clear answer for.

Our technology did not replace doctors' decisions, but it provided additional information where it was previously missing. It showed that we could try to assess not only the degree of damage to the optic nerve, but also whether it retained the potential to maintain or regain function.

PAP: How important is the fact that the solution can be used on standard clinical MRI scanners without the need to purchase specialized equipment?

Ł.L.: This is one of the greatest advantages of this technology. Many innovative solutions do not reach clinical practice because they require expensive equipment. In our case, we use data that can be obtained during examinations performed on standard MRI scanners available in many hospitals.

Of course, implementation will require appropriate algorithms, standardization of the procedure and full clinical validation. However, the lack of the need to purchase new equipment significantly increases the chances of practical application of this method.

PAP: From a doctor's perspective, how far are we today from a situation in which such an examination could become an element of standard diagnostics for patients with optic nerve diseases?

Ł.L.: We are at the stage of very promising research, but still before implementation into routine clinical practice. We have a patented technology, and early results indicate that it may provide information not available in current examinations. What we now need is research conducted in larger groups of patients, and the completion of the full regulatory path for medical devices.

We would like to emphasize that our method is not intended to replace OCT, visual field examination, electrophysiological tests or classic magnetic resonance imaging. Its role is to supplement current diagnostic tools with information on the microstructure of the optic nerve - especially in situations where current tests do not provide a clear answer to the question about the degree of damage or help make a difficult therapeutic decision.

PAP: What are the current greatest limitations of the solution and what stages of development remain to be completed before clinical implementation?

Ł.Ł.: We are at the stage that is called proof of concept in medicine - we already know that the idea works. However, there is still a long way to routine use in clinical practice.

Ł.L.: The most important step is validation on large, well-characterized groups of patients. It is not only about increasing the number of examined patients, but also about comparing the results of our method with the full set of tests used today in the diagnosis of optic nerve diseases - ophthalmological assessment, OCT, visual field examination, classic magnetic resonance imaging and electrophysiological tests. Only such a comparison will show whether the indicator we developed provides new, clinically useful information.

At the same time, we need to determine reference values for a healthy population, check the repeatability of the results, sensitivity and specificity of the method, and standardize it so that it gives comparable results on different scanners and in different centres. Since we are talking about medical software, it will also be necessary to complete the full regulatory path and obtain certification.

Ł.Ł.: We have established a partnership with Stanford Medicine and are planning a joint analysis of data from the UK Biobank-– one of the largest biomedical databases in the world. We gained access to it thanks to a Stanford research protocol. However, implementing this project requires a trip to the US, for which we are currently seeking funding.

This is a broader issue, however. We are simultaneously seeking funding for a multi-centre clinical trial in Poland. Despite collaboration with one of the world's best medical centres, a patent granted in the US, and promising research results, securing funding remains a huge challenge. This demonstrates how difficult the path from scientific discovery to implementation of technology in clinical practice is.

But we are not slowing down. The Centre for Technology Transfer WOTT at the University of Białystok supports the commercialisation of our solution. We presented the project at MEDmeetsTECH, are preparing to participate in HLTH Europe in Amsterdam, and are in talks with companies interested in further developing the technology. However, we know that commercialising medical innovations is a process that requires time, patience, and consistency.

PAP: Does interest from Stanford Medicine pave the way for joint research projects or international clinical trials?

Ł.Ł.: The answer is best demonstrated by the numbers. To date, we have prepared four joint grant applications, each requiring hundreds of hours of work by teams on both sides of the Atlantic. Previously, two projects - submitted to the Foundation for Polish Science and the National Centre for Research and Development - were finalized in the final evaluation stage. We came closest to success in the European Commission's Marie Skłodowska-Curie Actions competition, we were just half a percentage point short. Another time, a nearly 200-page project, carried out jointly with partners from two countries, including the Department of Physics at Indiana University Indianapolis, was rejected for formal reasons even before the substantive evaluation.

This demonstrates that the collaboration with Stanford Medicine is not a one-off contact, but a true scientific partnership. We are currently preparing another application to the National Science Centre, dedicated to basic research on the biophysical mechanisms behind the phenomena detected by our algorithm. At the same time, Stanford submitted its own project under the international collaboration funding program.

Both parties are investing their time, expertise, and resources, even though securing funding remains very difficult. This story shows that we are in a very good place scientifically and as a partnership. We have trust, a common goal, and ambitious research plans. However, an open door is not the same as the ability to walk through it. Whether we can fully utilize the potential of this collaboration and translate it into international clinical trials will primarily be determined by access to appropriate funding.

PAP: How important is obtaining a patent granted by the United States Patent and Trademark Office for the team and for the further development of the technology?

Ł.Ł.: The US patent office is one of the most demanding in the world. Granting a patent means that independent experts have confirmed that our solution is new, unobvious, and meets the highest criteria for intellectual property protection.

For us, this has several dimensions. First, it protects the technology in the largest medical technology market. Second, it paves the way for licensing and commercialisation. Finally, in discussions with partners and potential investors, it provides a strong argument confirming the value of the newly developed solution.

Of course, we would prefer Polish innovations to not need foreign validation. However, reality is often pragmatic - they say that what sells best in Europe is what America has already bought. We have not sold anything yet, but we already have a patent - just in case.

Interview by Anna Mikołajczyk-Kłębek (PAP)

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