We live in an app-based technological era. In fact, in the past decade, apps have become the ‘normal’ way we interact with third parties online. The list of examples is exhaustive and not restricted to the medical world. We are now able and sometimes expected to be ‘techsavvy’ enough to download an app to fill in a preoperative medical questionnaire prior to a consultation, to schedule a work meeting, to order a meal, or to organise transport home.

While some would argue that this type of advancement can be intrusive and demanding on people who are not as confident with information technology (IT), have limitations due to a language barrier, or simply prefer the old style pen and paper, it is the way society is evolving.

There is no doubt that this technology has its limitations. However, in medicine, it could be argued that the benefits far outweigh the inconvenience.

ARTIFICIAL INTELLIGENCE IN THE CATARACT SURGERY PATHWAY

Apps in medicine can be powered by artificial intelligence (AI) technology. While the one we describe in this article, i-Wise, does rely on AI in some limited respects, it is more of a traditional app, largely operating on standard, evidence-based information programmed by software developers. It serves as a detailed education resource as well as an important medico-legal resource, enabling the patient and clinician to ‘be on the same page’ regarding the cataract surgery procedure.

AI in this space is certainly not a new concept. We currently use – and often take for granted – AI in retinal and glaucoma sub-specialities. AI allows us to accurately grade a disc and predict visual field loss over time. Researchers are currently using AI capability to look at retinal and macular changes in age-related macular degeneration to predict the timeframe for when an intravitreal injection may be required, to prioritise patient appointments.2,3

The use of AI in cataract surgery at the preoperative stage can help surgeons better understand the pathology they are dealing with, thus allowing them to tailor the operation to each patient. For example, cataract grading through AI-image analysis uses mathematical models to recognise the potential for lens dislocation that may require additional surgical steps, as well as the ability to define co-existing anterior segment pathology, such as corneal haze or keratoconus.4 Intraocular lens (IOL) power calculations currently use AI technology to help better predict refractive outcomes. They take into account different biometric parameters, such as axial length, keratometry, anterior chamber depth, and patient gender, along with optional variables including lens and central corneal thickness.5 However, even these have some limitations that clinicians need to consider in each case.

Intraoperatively, our operating rooms may soon be transformed with digitalisation. A commercially available AI system for ophthalmic surgery, Touch Surgery Enterprise (Medtronic), recently became available in the United States. Touch Surgery Enterprise is a video management and analytics platform. Surgeons can use it to upload operating videos that enable AI-driven analytics to segment each case into phases and provide surgical insights while operating.6 Additionally, the introduction of interactive voice-driven AI systems can provide further information about the operation or medical information about the patient.7

It is important to recognise that while this technology is impressive in its own right, its utility is diminished if it is not used to enhance the surgeons’ technique or preparation for each case. As a result, all these machine learning algorithms should be accompanied by a simultaneous human learning curve with the ultimate goal that the two will eventually occur in perfect synchrony.

VISUAL SIMULATION TOOLS

Further to this, visual simulation tools are now being effectively used in the United States to better describe features of the many IOL options available and demonstrate these to a patient in the consulting room. Some examples include the Acrylsoft (Alcon) IOL visual simulator, Carl Zeiss Meditech Visual Simulation tool, and Technis Vision Simulator website (Figure 1).8 These are exciting tools that allow the patient to be in the so-called ‘driver’s seat’ and experience possible visual outcomes. Importantly, these tools demonstrate concepts that are often difficult to explain, especially to patients with pre-conceived ideas about what to expect following cataract surgery. They streamline the consultation, making for greater time efficiency in busy clinics.

Figure 1. Visual simulators offer patients the ability to experience the outcomes of various IOL types and under varying lighting conditions. Pictured is the Tecnis Vision Simulator (Johnson & Johnson Vision), available at tecnisvisionsimulator.com.

THE I-WISE APP FOR CATARACT SURGERY CONSENT

Our project is a venture with the University of Melbourne and RMIT University to design a patient-specific app, called i-Wise.

The app will inform patients about their cataract surgery procedure, what is involved in the process, the primary risks that may be encountered, how these may be mitigated, and the patient’s expected pathway to recovery. Key to the app is that it is designed specifically for patients; it aims to simplify medical terms so that patients understand their procedure, and can even explain it to their friends and family.

For patients with English as a second language, i-Wise is compatible with most language translators including Google translator.

The i-Wise app affords patients the luxury of using the resource at their own pace and returning to it at any time to refresh their memory on challenging concepts. This level of understanding and opportunity to reflect is often difficult to achieve in a short consultation, leaving some patients unclear of the aims and expectations of their surgery.

i-Wise also includes a brief ‘test your knowledge’ section, with certification, that helps patients commit to their understanding of the cataract surgical pathway. This is important as it not only empowers patients in their surgical journey but also confirms to the clinician that the consent process has been undertaken.

Prior to its official release later this year, the i-Wise prototype will be beta-tested by a focus group and a closed clinical community for feedback. Following this, it will be freely available for download and use on both Apple and Android devices.

WHAT IS INFORMED CONSENT?

Informed consent is used in medicine for treatment procedures and surgery, as well as in research. In the process of informed consent, information is presented to the patient to ultimately allow them to make an informed decision regarding treatment without coercion.9 In its most basic sense, this may include the type of procedure performed, the type of anaesthetic used, how and where the procedure may be performed, the expected outcomes, and a brief overview of the risks, both general and specific to the patient.

The process is a fundamental and ethical obligation involving patient and doctor, and underlies one of the most important aspects of medicine as outlined in the Hippocratic Oath: beneficence, non-maleficence, and respect. Unfortunately, too many patients regard consent forms as a mere procedural obligation, not completely understanding the gravity of the process. This often means that the ethical obligations of consent are not met.10

Several studies have looked at informed consent for cataract surgery over the years, focusing on various aspects, including the extent of patient comprehension, their ability to recall important aspects of consent, and analysis of their understanding of risk.

Kikuchi et al. found that the majority of patients did not comprehend the preoperative information provided, highlighting the importance of including both patients and family members in the consenting process.11 Morgan and Schwab reported patients’ recall of the consent even one day later as sub-optimal.12 Furthermore, Kiss et al. reported that 76% of patients believed cataract surgery was risk-free, while Cheung and Sandramouli reported 48% believed it was risk-free, rising to 80% in those planning a second cataract surgery.13,14

While these studies do not comment on reasons for large gaps in misunderstanding of the consent process, it is likely multifactorial. Patients’ anxiety when presenting for surgical consultations can affect comprehension and information retention. The presence of family members may sometimes add to this confusion as each individual’s understanding may differ. Time constraints in a busy medical clinic do not always allow for an in-depth discussion, and information leaflets may not align exactly with a surgeon’s explanation.

Applying Informed Consent to i-Wise

So, what is important to include in the informed consent for cataract surgery? Should we be individualising consents, depending on the patient sitting before us? Can we ensure that every patient achieves a basic level of understanding of the process?

In essence, the purpose of this app is to allow individualised understanding of the cataract surgical process. i-Wise allows patients to research information in real time, come and go as they please, and access this information in the order they prefer. The use of everyday language and the deliberate attempt to avoid lengthy medical explanations targeted at a high-school understanding makes it amenable to most users. While ‘keeping it simple’, the app provides links to a medical dictionary and more advanced information should patients wish to learn more. The use of figures to educate the user on eye anatomy, as well as schematics such as pie and bar graphs discussing adverse events, and tables to explain important differences of key concepts such as laser-assisted surgery versus conventional surgery, are useful tools for the visual learner (Table 1).

Informing Patients About Surgery Beyond the Routine

As per a consent process conducted in the consulting room, i-Wise aims to focus initially on the routine scenario where most patients will experience an uneventful cataract surgery procedure, with a pre-planned IOL implant and a positive outcome.

As there are always exceptions to a rule, it will then group deviations from this routine scenario into three separate groups:

Requirement for an additional procedure (planned or unplanned, but routine). In most instances, this can be ascertained at the initial consultation when a patient is thoroughly assessed. Some common examples include use of Vision Blue to enhance visualisation when operating on a dense or white cataract. Another is the use of an iris manipulation device, such as iris hooks or a Malyugin ring, to manually enlarge the pupil intraoperatively in cases of a poorly dilating pupil, previous iris synechia, or if the patient is using alpha-antagonists that contribute to ‘intraoperative floppy iris syndrome’ (IFIS). In addition, patients with ocular co-morbidities, such as diabetes or a previous history of ocular inflammation, may require additional intervention in the form of corticosteroids, intravitreal anti-VEGF, or biosimilar agents at the time of surgery. Patients with a diagnosis of primary open-angle glaucoma (POAG) may also require insertion of a minimally invasive draining device and require additional measures postoperatively to reduce intraocular pressure.

Table 1. Comparison of femtosecond laser-assisted cataract surgery versus routine surgery that will be presented via the app as part of the education and consent process.

Requirement for a secondary procedure (planned). In some cases, a thorough consultation may highlight certain features that increase a patient’s risk for an additional procedure. These include the presence of pseudoexfoliation material (PXF), which may contribute to weak zonules and increase the risk of lens dislocation intraoperatively. In these cases, informing the patients of a planned anterior vitrectomy, the possibility of intraoperative corticosteroids, and a modification to the previously discussed IOL may be required. In this instance, they must realise that they may still be dependent on glasses postoperatively.

Requirement for a secondary procedure (unexpected). A careful risk assessment of a patient at the initial consultation can also determine the likelihood of this possible scenario, and prepare the patient for it. This may occur in the scenario of zonular dialysis or a dehiscence of the posterior capsule resulting in a complete dislocation of the lens or lens fragments to the posterior segment, requiring a secondary procedure by a vitreoretinal colleague and subsequent placement of an alternative IOL. In another scenario, a fragile cornea with a reduced endothelial cell count, assessed preoperatively, may undergo further decompensation following cataract surgery requiring a secondary procedure such as a Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK). In all these scenarios, patients need to be aware that while their recovery may be longer, in most cases a positive outcome can still be achieved.

MANAGING EXPECTATION AND ANXIETY

Apart from a deviation from the routine process, care was taken in the creation of the i-Wise app to avoid the inclusion of a complete list of all adverse events that may possibly be encountered in cataract surgery. This was deemed unhelpful and unclear.

Research has highlighted that common anxieties patients have following cataract surgery are associated with bleeding or bruising, swelling and infection and, in particular, how these factors may implicate vision loss. Therefore, the app focuses on infection, in particular endophthalmitis, and highlights this as a rare but serious complication of cataract surgery with the incidence varying from 0.02% to 0.71%.15 In the interest of patient education, there is mention of how improvements in pre-and intraoperative surgical measures have significantly reduced this infection rate. Further information regarding the use of intraoperative antibiotics is included with particular reference to the pivotal European Society of Cataract and Refractive Surgeons (ESCRS) study and its recommended use of antibiotics, as without this, there is a five times increase in risk of developing endophthalmitis.16

Similar information about expected inflammation from minor corneal haze, which clears quickly, to longer-lasting posterior segment inflammation and pseudophakic cystoid macula oedema (CMO) is featured in i-Wise. A link is made between postoperative inflammation and the need for optimal compliance with post operative drops to promote healing. The newer ‘dropless’ cataract surgery regimen is also mentioned with current evidence that supports this. Once again, the app allows for more detailed medical information should the user request it, including the reported incidence of CMO in the range of 0.6% to 4.0% and plausible risk factors such as diabetes mellitus (DM), posterior segment inflammation, and prostaglandin analogues, which have been implicated.17

LIMITATIONS OF THE CONSENT PROCESS: DOES ONE SIZE FIT ALL?

I have often found, when consenting patients for any procedure, more than one modality needs to be employed to get the most accurate information across. In my practice, I use a variety of methods, including verbal explanations supplemented with illustration or use of an eye model, as well as a carefully selected pack of patient-specific brochures relevant to their procedure. Having the i-Wise app at hand will be an additional tool in our armamentarium in consenting patients, allowing them to access this information at their own pace and ensuring the information provided is clear and concise.

CONCLUSION

There is no doubt that we are navigating a world where health care is being remodelled with the use of digital technology. This revolution has many positive implications, but needs to be controlled appropriately to ensure the most accurate information is disseminated.

The i-Wise app is a means of taming this digital transition into healthcare, offering our patients a first-hand opportunity to be well-informed in their decision making and invested in their health outcomes.

References available at mivision.com.au.