2019: Top ophthalmic challenges

December 5, 2018
OTE Staff Reports

Ophthalmology Times Europe Journal, Ophthalmology Times Europe December 2018, Volume 14, Issue 10

As the year 2018 winds to a close, thoughts begin to turn to the next challenges for ophthalmology in the new year.

Top of mind for many are concerns over the diagnosis and management of refractive disease, cataracts and intraocular lenses, glaucoma, and retinal disease, in addition to the role of imaging in ophthalmology. Five members of the Ophthalmology Times Europe Editorial Advisory Board share their perspectives on the top challenges that ophthalmologists likely will face in 2019.

Thoughts on refractive surgery

Dr Alió:The debate over small-incision lenticule extraction (SMILE) versus LASIK has been around for the last 5 years. Even though the outcomes of both techniques are similar, the potential and logical advantages that SMILE has over LASIK in the preservation of biomechanics and tear film stability should be in favor of SMILE. Improving centration, astigmatism control, and biomechanics are a real challenge for the clinical researchers and the industry. SMILE will open the doors to intralamellar refractive surgery, which, in my opinion, in a given moment will replace LASIK as it is technologically more cost effective (we eliminate the need for flap and other technology associated to it), and it is minimally invasive.

Presbyopia is a long-standing problem that is still unsolved. At this moment, intracorneal inlays have failed to work as many thought they would.
Intracorneal inlays are declining because their promising results have not been confirmed in clinical practice by many surgeons. Unrealistic expectations and overly positive reported outcomes from the industry have led to their discredit. Some of them have even disappeared from the market following years of theoretically proven benefits. These technologies, such as the Kamra inlay, will have a better future once a more systematic approach to their implantation, centration, and long-term outcomes are available.

Pharmacology treatment of presbyopia is an open issue still unsolved. Intraocular phakic presbyopic lenses are a new upcoming issue that should provide a stimulating option for the patients. PresbyLasik is successful today as long as adequate patient selection is  performed with the adequate technology. PresbyMax from Schwind, LVV from Zeiss, and PresbyOn from Bausch & Lomb are finding their role in the treatment of presbyopia. Intraocular lenses are the state-of-the-art over the age of 55 as they provide a permanent solution but a higher risk, as intraocular surgery mis always more invasive.

Dr Kermani: The demand for laservision correction (LVC) is stable, if not increasing. It very much depends on the general economic situation in 2019. Our results with Femto-LASIK and topoguided ablation profiles (Contoura by Wavelight) have never been as good as they are now, now that we see the 12-month outcomes. Regarding the adoption of SMILE for us, economically, it doesn’t make sense.

In terms of outcomes, it will be hard for SMILE to beat Femto-LASIK. It’s all about the future. SMILE is a fascinating procedure and if you look at the current publications, it will pick up soon and perform equally good. In 2019, there will be more companies coming out with new SMILE femtolaser systems. This is good and will move the market in the right direction. My personal favorite and a silent star in LVC is trans-PRK.

After Schwind, Wavelight is now coming up with StreamLight. No-touch LVC is attractive for patients, and the post-op pain is well-controlled with topical and systemic non-steroidal anti-inflammatory drugs. Refractive lens exchange (RLE) mis the new LASIK. The demand is increasing, but we have not yet reached the numbers that we have with LVC, despite the fact that the number of available patients with money in the pocket is significantly higher in the baby boomer generation than Generation X. I am often asked by the industry why the number of multifocal IOLs is so small in the overall picture. The answer is simple. Multifocal IOLs aren’t yet good enough. If they were, RLE would be the new LASIK.

In Germany, crosslinking (CXL) is becoming a procedure that will be fully covered by statutory health insurance. This is good. However, we often combine the procedure with topo-guided PRK (Athens protocol) with good results. Topo=guided CXL is now out and in 2019,we will have to decide whether to adopt this new procedure or not.

Thoughts on cataract surgery and IOLs

Dr Alió: Multifocal lenses are reaching maturity because the latest improvements in multifocality have demonstrated
safety and tolerance by many patients.

However, the greater the near vision add, the greater the challenge for neuroadaptation, distortion, halos, and glare. Extended depth-of-focus (EDOF) lenses have tried to reduce these problems with so-called extended depth of field, which provide small changes in the optical behavior of the IOL, which adds some value for near. The problem is that these changes, such as asphericity changes, are not customised and work unevenly in different patients.

Changes like achromatisation do not really extend the depth of field but, rather, increase other functions. Overall, EDOF lenses cannot be based only on aberrations because when aberration changes are high, they decrease the optical quality of the retina to unacceptable levels. The amount of customisation that multifocal with EDOF changes is still to be defined. Pure EDOF lenses are, in my opinion, failing because they induce unacceptably bad quality of vision and are insufficiently strong for near vision to be spectacle independent.

Finally, accommodative lenses show evidence that sulcus implantation is ideal. We should continue to see promising results about this in peer-review journals.

Dr Augustin: Cataract surgery is increasingly characterized by patient expectations to live without glasses and the relative attempt to make a surgical correction of presbyopia. The introduction of multifocal IOLs  has allowed a response to this request. Since their introduction, multifocal IOLs have the ability to promote near and distant vision simultaneously. Nevertheless, some subjective complaints, such as glare, halos, starbursts and unsatisfactory distance vision have been reported by the patients.

Moreover, there is the increased demand of intermediate vision among the population using tablets and smartphones. These patients request “something more” than a normal multifocal IOL. The goals of reducing spectacle dependency and optimising postoperative visual mquality after cataract surgery have driven the development of EDOF IOLs. The main advantage of EDOF lenses compared to multifocals includes a reduced incidence of photic phenomena, improved uncorrected intermediate visual acuity, and no loss of contrast sensitivity. In this way, EDOF lenses may be an effective solution for the growing  number of presbyopes who desire good visual acuity at all distances.

Dr Kermani: Which multifocal IOL will be the winner in 2019? There is no simple answer. Basically, both trifocal and EDOFs perform well, with compromises in night vision, glare and halos. The main task is to identify a “good” patient. There is no 100% prediction that your pick and recommendation is correct, even if you are an experienced surgeon. I also do not believe in pre-op behavior evaluations.

After all, what counts is when the IOL is in the eye and you take the bandage off the day after surgery. Everything can be different from what you expected. My solution? I am shifting to multifocal AddOn systems, the Cristalens from France, 1st Q from Germany, and Rayner from Great Britain have excellent sulcus AddOn trifocal IOLs. The winning point is the reversibility. If the IOL does not perform and the patient is unhappy, it is so easy to take it out again. So what? Nothing has happened.

Thoughts on Glaucoma

Dr Augustin: Research in the field of antiglaucomatous medications has recently led to the introduction of a new class of drugs into the pharmaceutical market in Japan and the U.S.: the Rho kinase (ROCK) inhibitors. These new drugs represent members of the first new class of clinically useful ocular hypotensive agents since the U.S. Food and Drug Administration approval of latanoprost in 1996.
The ROCK inhibitors act by modulating the cytoskeleton at the level of trabecular meshwork and Schlemm’s canal, thereby
reducing the outflow pathway resistance and-by doing so- reducing the intraocular pressure.

I believe it is fundamental to have another treatment option in the management of glaucoma. Moreover, the ROCK inhibitors
also have showed two other considerable effects. First, they have been demonstrated to be effective in combination with other ocular hypotensive medications, such as the prostaglandin analogues. In addition, they also appear to have a neuroprotective activity, a favorable impact on ocular blood flow, and even an antifibrotic effect that may prove to be useful in conventional glaucoma surgery.

The combinations of all these properties offer a great chance for specialists to battle an arduous disease such as glaucoma.

Dr Holló: To prove the advantage of the various microinvasive glaucoma surgery (MIGS) devices over classic mitomycin C (MMC)
trabeculectomy based on their cost/benefit ratio remains a challenge. In countries where a general health insurance system
is used (e.g., in many countries in Europe) a trabeculectomy with an adjunctive antimetabolite is much cheaper than a MIGS
device alone.

Thus, the price of the various MIGS devices on the top of the cost of surgery cannot be justified for reimbursement. In particular, the IOP-lowering efficacy does not exceed that of MMC trabeculectomy, even when the best studied MIGS devices are considered.

Therefore, I think that in countries with a general health insurance system, the use of MIGS will remain minimal in 2019. In 2018, two separate prospective multinational European studies on the referral of glaucoma patients for diagnosis of glaucoma and for first-time glaucoma surgery were published. In the article that addressed the appropriateness of referral for glaucoma diagnostics by general practitioners, optometrists, and ophthalmologists, the figures were generally poor for all categories. In the second article, it was found mthat patients with open-angle glaucoma are referred for their very first glaucoma surgery later and in a more severe stage of the disease in the old European Union countries than in the new European Union countries and in the new European Union countries than in the non-European Union European countries.

This clearly shows that the more options ophthalmologists have to avoid surgery, the longer time that is necessary for the decision on surgery. However, the price paid for this is disease worsening. This attitude should be changed, and surgery should be promptly recommended to patients. This will be a major task for the upcoming years.

Dr Kermani: Interventional glaucoma surgery is gaining ground, and I believe in 2019 we will triple our numbers. The question our CFO is bringing up first is about the cost of the MIGS devices. It’s nice and elegant surgery, but it’s expensive. In our clinic, we have two schools-one favors simple goniotomy, and the other prefers the iStent as mainstream procedure. We will have to look at the long-term results in a few years and follow the publications and conferences.

Thoughts on retinal imaging

Dr Holló: The understanding of the time-dependent changes in OCT angiography (OCT-A) remains a major challenge in glaucoma research.

Recently, it has been shown in prospective longitudinal studies that peripapillary OCT angiography results are more variable than the corresponding retinal nerve fiber layer thickness (RNFLT) results; removal of the effect of the large retinal vessels improves the detection of glaucomatous progression with peripapillary OCT angiography; posterior subcapsular cataract influences the peripapillary OCT-A measurements more that the RNFLT measurements; and smoking and breath holding have no influence on the measured  peripapillary OCT-A results.

Thus, to better use peripapillary OCT-A for the detection and measurement of glaucomatous progression, further studies are necessary.

Dr Stefánsson: Retinal imaging should be recognised as surrogate endpoints for treatment intervention. For example, in diabetic macular oedema (DMO), it should be recognised that reducing retinal oedema as seen on OCT images is a relevant treatment endpoint. Because diabetic retinopathy grades on fundus photographs are already recognised as a surrogate endpoint, the OCT also should be acceptable. This is also in agreement with many other surrogate endpoints, such as intraocular pressure in glaucoma, arterial blood pressure in stroke, and tumour size in cancer.

Dr Augustin: The most recent progress in the field of retinal imaging has been focused on the ultra wide-field (UWF) approach, which has allowed visualization to reach the retinal periphery up to 200°, having the capability to cover approximately 82% of the retina in a single image. This new
method offers the possibility to have a fast, detailed and unique comprehensive overview of the whole retina without the need of a post-processing reconstruction of more images.

I think it’s a considerable development, mostly for the achievable application of UWF imaging to fluorescein angiography (FA) and indocyanine green angiography (ICGA). The introduction of UWF-FA may lead to a great  mprovement in the diagnosis and management of diabetic retinopathy through the identification of novel angiographic features, including the exact quantification of the extent of ischemia and other pathologies in peripheral retina.

UWF-ICGA may be useful to better analyse peripheral abnormalities in age-related macular degeneration (AMD) and alterations of the vascular permeability in the central serous chorioretinopathy that otherwise would not have been imaged.

Moreover, UWF-ICGA plays a relevant role in the analysis of some uveitic conditions, including birdshot chorioretinopathy,
syphilis, sarcoidosis, and multifocal choroiditis, in which the retinal periphery is mainly involved.

Pachychoroid neovasculopathy is a relatively new retinal disease that has drawn the attention of retinal specialists. This clinical entity is mainly characterised by the presence of Type 1 choroidal neovascularisations associated with signs of increased choroidal thickening and hyperpermeability. The latter features are distinctive of pachychoroid spectrum disease, which also includes pachychoroid pigment epitheliopathy, central serous chorioretinopathy, and polypoidal choroidal vasculopathy. It has been demonstrated that these pathologies share common features, such as choroidal vascular dysfunction, abnormalities of the retinal pigment epithelium without showing typical characteristics of AMD, and, occasionally, choroidal new vessels.

As a way to approach this new disorder, I would suggest using a  ultimodal imaging modality, improved by the use of OCT-A. The development of the most recent OCT-A software offers valuable help, mostly to distinguish choroidal neovascularisation in the spectrum of pachychoroid disease from typical neovessels appearing in AMD, leading to a more specific and individualized management.

Thoughts on retinal disease, diabetic eye disease

Dr Stefánsson: The global epidemic of diabetes continues. Over 400 million persons have diabetes now and this is projected to exceed 600 million by 2030. This is one of the biggest epidemics in the history of mankind. We know that two-thirds of diabetic patients develop diabetic retinopathy within 20 years, and one-third develop sight-threatening retinopathy. The global epidemic of diabetes will become a global nepidemic of blindness if preventive measures are not instituted. Diabetic eye screening and appropriate preventive treatment are proven ways to reduce the risk of blindness from diabetes.

However, only a small minority of diabetic people, perhaps 10% or less, have access to regular screening. The participation of patients with diabetes in eye screening programs must be increased around the world to prevent a wave of diabetic blindness in the future. mDiabetic eye screening can be made more efficient and economically feasible. With annual eye screening for diabetic patients, only 2–3% are referred for treatment. Individualised risk assessment can improve this ratio.

If screening frequency is based on the individual risk profile (i.e., each person’s risk of developing sight-threatening retinopathy) the overall number of screening visits can be cut in half while catching mall diabetic patients who need treatment. Risk profiling increases the screening frequency of high-risk patients, while low-risk patients are spared from unnecessary clinic visits. The cost to individuals and society can be cut in half while maintaining medical effectiveness.

This makes systematic diabetic eye screening more economically feasible, also for poorer nations.

Retina clinics are being overwhelmed with the number of intravitreal injections needed for our patients. In my small clinic in Iceland (population 350,000) we have gone from no injections to 8000 per year in a decade, and this is by far the busiest activity in clinic. It is also the most common “operation” in the hospital. While relatively rich developed countries are able to sustain this effort, it is clearly beyond the capacity of many countries around the world.

While wet AMD is responsible for the majority of intravitreal injections, diabetic eye disease is an important and rising cause. Diabetes is increasing rapidly in most populations and is still the most common cause of visual impairment in working-age people in many counties. Diabetic macular oedema (DMO) and recently some cases of proliferative diabetic retinopathy are treated with intravitreal injections. DMO is the most common cause of visual impairment in diabetes. There are currently 25- to 30-million people with DMO in the world, but only about 2 million are receiving intravitreal injections or implants.

Monthly intravitreal injections are not a sustainable treatment option for large populations on a global basis. Drug delivery options that are less demanding on health care resources must be developed. Several options are being studied. These include intravitreal injectables and implants that have longer duration of treatment as well as noninvasive treatment options, including eye drops. Eye drops have the obvious advantage of being self-administered, making them more accessible to large populations. While anti-vascular endothelial  growth factor (VEGF) drugs have been a godsend for patients with wet AMD, DMO, and several other sight-threatening diseases, this treatment is not perfect.

Our AMD patients no longer face the threat of losing 6 lines of vision, and DMO patients can expect some improvement in vision rather than the stability offered by laser treatment before. However, only about one-third of patients with wet AMD and DMO can expect optimal outcomes from anti-VEGF treatment with substantial improvement of vision and a similar ratio of patients see virtually no improvement in visual acuity following intravitreal injections.

We need to do better and offer these patient groups a higher probability of visual improvement.

New treatment pathways are being explored, and an emphasis needs to be placed on the inflammatory and ischemic origins of these diseases. Combination treatments have done wonders in many fields of medicine, such as with AIDS and high blood pressure. Combination treatments should be explored in AMD and diabetic eye disease, and regulatory agencies need to support this approach.

Thoughts on Practice Management

Dr Alió: Cost effectiveness is becoming an issue. The ophthalmologist and, generally speaking, the economy of an ophthalmic office cannot afford techniques that are not cost effective because the investment is never recovered, and neither is there a benefit for the  patient.

Studies that demonstrate that a new technology is capable of bringing advantages to patients and guarantees a return that is payable or  recovered in some way are those that will be chosen by doctors in the future. This information is necessary because costs are becoming a long-standing problem in health care, both in private practices and in public health care systems.

Disclosures:

DR JORGE L. ALIÓ
e: jlalio@vissum.com

DR ALBERT J. AUGUSTIN
e: albertjaugustin@googlemail.com
Dr Augustin declares no financial interests.

DR GÁBOR HOLLÓ
e: hgbudapest@gmail.com
Dr Holló declares interests with Alcon Laboratories, Optovue, and Santen.

DR MED OMID KERMANI
e: o.kermani@augenportal.de
Dr Kermani declares no financial interests.

DR EINAR STEFÁNSSON
e: einarste@landspitali.is

The views in this article are those of the respective European physicians expressing personal opinions of the results
they have seen to date and do not represent the views of Ophthalmology Times Europe or UBM Medica.

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