OR WAIT null SECS
In this Q&A with members of the Ophthalmology Times Europe Editorial Advisory Board, participants take a look at some of the top challenges and opportunities facing ophthalmologists in Europe today.
Editor’s Note: 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, Ophthalmology Times Europe, or UBM Medica.
As the year 2016 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 retinal disease, glaucoma, and cornea/anterior segment disease, along with a watchful eye on a new administration in the United States.
Five members of the Ophthalmology Times Europe Editorial Advisory Board share their perspectives on the top challenges that ophthalmologists likely will face in 2017.
Thoughts on retina
The global pandemic in diabetes produces an epidemic of diabetic eye disease that strains ophthalmology resources.
There were 150 million diabetic patients in the world in the year 2000 and now there are 430 million. Two-thirds of type 2 diabetics develop retinopathy and one-third reach sight-threatening retinopathy in their lifetime.
Screening and preventive treatment is the way to go, but global resources cannot deal with annual screening of this enormous group of patients. Also, the ophthalmology resources to provide lifelong intravitreal injections for tens of million of patients with diabetic macular oedema are not available.
Eye clinics around the world are already strained by the treatment load of intravitreal anti-vascular endothelial growth factor (VEGF) injections for wet age-related macular degeneration (AMD). Aging populations will increase the number of patients over the coming decades. At the same time, this treatment should be made available to more wet AMD patients and at optimal frequency. Various treat-and-extend protocols are a compromise between healthcare resources and patient needs. Many elderly patients are receiving fewer injections than what would give them best vision outcome.
While anti-VEGF injections have been a godsend for patients with wet AMD, diabetic macular oedema, and other retinal diseases, the fact remains that many patients have a modest or even no-treatment response. More pathophysiologic mechanisms must be targeted. This may include inflammation and also other cytokines
Combination therapy must be considered for those patients with wet AMD, diabetic macular oedema, etc. who have insufficient response to anti-VEGF monotherapy.
The number of patients receiving intravitreal operative medication (IVOM) for wet AMD is increasing every year. In my clinic, I do see cases with therapy refractory to wet AMD more often. What are we going to do with them? Continue with IVOM after 15 to 20 injections? What kind of life quality is this? And at what costs? A life before and after the next injection.
Brachytherapy in combination with vitrectomy was an alternative, but the company failed to perform proper studies and busted. Oraya? It has become quiet around this radiologic approach. Not a good sign.
There are rumors of a new brachytherapy approach. This time vitrectomy is not necessary. The approach is ab externo. Let us see what they are coming up with, and hopefully, this time the company takes care that the studies are performed with quality and care.
We have alternatives for several diseases, such as diabetic macular oedema, macular oedema due to retinal vein occlusion, and wet AMD. This means that we must evaluate the outcome early in the treatment course and decide to switch to other approaches if appropriate.
In addition, combination treatments are under consideration. Those strategies should be evaluated further.
Besides those diseases which can be already treated with evidence-based strategies, another challenge is dry AMD. We are expecting results from several studies for the treatment of this disease entity.
Hopefully, we can also expect alternatives.
Furthermore, we still need clear measures for a better evaluation of such a treatment. Several measures, such as autofluorescence, did not prove to be a reliable measure because of many uncertainties.
Thoughts on imaging and OCTA
Ocular imaging tools to better evaluate both therapeutic strategies and the pathophysiology of many diseases are rapidly expanding and improving. Especially, improvements in optical coherence tomography (OCT) imaging of the posterior and anterior segment need further critical evaluation.
This is not only true for OCT angiography (OCTA), which may add additional knowledge on perfusion characteristics of different layers of the posterior segment, but also for higher resolutions and imaging modalities. Those are swept-source OCT and the “en face” presentation.
OCTA for glaucoma (and retina) has been gaining increasing interest and importance.
Of the different OCTA systems currently available, the AngioVue OCTA provides the most developed, quantitative evaluation on disc and peripapillary angioflow density, and provides data for various sectors of the peripapillary as well for different layers, separately.
It was recently shown that the measurement is reproducible, able to separate glaucoma eyes from normal eyes, correlates with the corresponding retinal nerve fibre layer thickness (RNFLT), visual function ad visual field damage, and shows improvement after significant reduction of IOP.
The value of OCTA vessel density change in early detection of glaucomatous progression (in comparison to that of RNFLT change) is a particularly important question, to which follow-up studies need to be done in the next years.
Although their role is now established in the treatment of glaucoma, more extensive and early use of fixed-combination drugs is expected for the next years. All glaucoma patients need long-term medication, may potentially undergo filtration surgery, and will develop age-related dry eye, etc.
Thus, wider use of preservative-free, fixed-combination glaucoma drugs is definitely expected.
I expect further intensive discussions on the various minimally invasive glaucoma surgery (MIGS) devices since new implants are in the pipeline. But at the same time, I am sure that MMC trabeculectomy and glaucoma drainage devices will preserve their leading role in the surgical treatment of glaucoma for several years.
Patients’ adherence to topical glaucoma medication is suboptimal and needs to be improved. To this, new methods are needed, and the role of compliance trainings need to be better evaluated. Influence of cultural background on the effectivity of compliance trainings needs also to be analysed.
This is essential since many ophthalmologists are not fully familiar with the instrument (software) provided options, and the understanding of the background mathematical basics also remains suboptimally understood.
Haag-Streit published its new Visual Field Digest (a completely renewed 6th edition) which is available as a book and is feely downloadable from its website (www.haag-streit.com/haag-streit-diagnostics/campaigns/visual-field-digest). This book is very didactic and comprehensive, and guides the reader stepwise across the different stages of understanding visual field analysis, progression analysis, and automated kinetic perimetry, and presents several typical cases to improve readers’ skills on using modern visual field testing technologies.
Cost-effectiveness of laser cataract surgery
Femtosecond laser-assisted cataract surgery (FLACS) has become one of the hot topics in the last years in cataract surgery. However, its lack of cost effectiveness, the time that it requires, and the space in the operating room have become serious issues against its global adoption.
The only issue in which it seems to be offering a real advantage is in capsulorhexis. Devices, such as the Zepto or Capsulaser, are challenging the performance of capsulorhexis with a far lower cost for ocular surgeons, which would avoid FLACS to be adopted.
It is time to offer real evidence about the effectivity of FLACS or to reduce its excessive cost, or otherwise its progression will be challenged.
During the American Academy of Ophthalmology annual meeting, the question of whether FLACS is worth the considerable cost was the subject of a debate. One major issue is the longer procedure time and the high cost which must be covered by the patient. The potential advantages, such as a precise capsulotomy and reduced endothelial loss, are not unequivocally accepted.
Overall, the evidence for other advantages seems also to be very weak. Even a meta-analysis on the comparison of FLACS with manual surgery suggests that the advantages and disadvantages of FLACS may cancel each other out.
One final conclusion of this debate was that FLACS may find its place for severe cases as a niche product.
Next year, surgeons need to further evaluate this procedure.
In my opinion, it is the presbyopic patient who is emmetropic. Kamra failed to convince. Raindrop? “I do not like plastic in the cornea,” Prof Kanellopoulos from Athens says, and I agree. I would rather wait a few years to see what will come up with this new method, regardless if it is approved by the FDA.
So what is the alternative? Prof. Waring is paving the way. Is it only presbyopia or is it lens deficiency syndrome? Prof. Waring’s concept of lens deficiency syndrome is more than a euphemism. It makes sense and patients understand it.
If presbyopia is the earliest onset sign of cataract development, then it is not a matter if we propose lens exchange, the matter is when we are proposing lens exchange. Why would we want to let our patients suffer, until vision has decreased below 20/40? With modern laser technology and IOL design, refractive lens exchange might also become the method of choice for the emetropic presbyope.
Presbyopia IOLs have been progressing with sophisticated multifocality optics, such as the varifocal (Oculentis), extended depth of focus, and trifocals.
These three technologies provide advantages and disadvantages, with a clear progressive increase in their adoption by surgeons and patients. The outcomes have been increasing and the particular role of each technology is unclear. It is my opinion that trifocals and varifocals are superior to extended-depth-of-focus lenses.
In this year, I expect that evidence will support one or the other in a way that surgeons can have independent and well-supported information on what to use.
Among the many techniques suggested for the compensation of presbyopia, intracorneal inlays have always been on the stage due to their minimally invasive character, their reversibility (in part), and the accessibility of the technique as it does not require high technology or sophisticated surgery.
However, in spite of all these theoretical advantages, the lack of reproducibility, the frequent intolerances happening in patients, and the explantation rate which is definitely higher than that reported by company-sponsored studies have made this topic not to be progressing adequately.
During 2017, I hope real evidence will arise in favor of intracorneal inlays-particularly the Kamra, the Raindrop, and Flexivue, which are those most extensively used. Lack of evidence will limit adequate expansion into the market and what is true is that previous evidence provided by the companies has not been backed by real results. This is the time to prove this.
Among the new emerging topics, and still not in practice, is the pharmacological therapy of presbyopia. Some companies are developing at this moment some topical treatments to increase the accommodation by reactivating the ciliary body (FOV presbydrops) or soften the lens (Encore Vision study), while others are simply using myotics.
These drugs should be used binocularly as pharmacological monovision is not, in my opinion, attractive for refractive surgeons.
If this is really on a practical basis helping patients with early and intermediate presbyopia, this can become a huge issue and indeed studies supporting or providing evidence on this alternative treatment of presbyopia will be most welcome and of huge interest.
Cornea and dry eye
Tear film deficiency again was in focus in 2016 at our clinic. We invested in TearLab and learned a lot about tear film deficiency and osmolarity. The challenge will be advanced treatment of tear film deficiency.
There are many new options from steaming goggles to light pulses. Which is the best? Do we need a combination of therapies as Prof. McDonald proposes? Nutritional additives, local pharmaceutic and physical therapy, as well as systemic treatments with hormones? It seems to develop a subspecialty in our field.
In my city, the university hospital has inaugurated a dry eye outpatient department. Last week, I tried to get an appointment for a patient suffering from severe refractory dry eye. She was ready to pay private. Next open appointment was in April 2017. This tells you what is going on with dry eye. Challenges and opportunities.
Ectasia-angst! What a beautiful word creation. I read this in an article from Prof. McDonald.
Prof. Brad Randleman added the 40% rule to his risk score table, noting that the sum of flap thickness and ablation depth should not exceed 40% of total corneal thickness.
Very helpful for risk assessment; yet, can we prevent ectasia? One-third of ectasia cases had normal corneas prior to surgery. Ectasia has prevalence also with SMILE. No big difference.
What is needed is ectasia prevention in order to overcome ectasia-angst. LASIK Xtra could be the way to go. The company, however, fails to deliver studies to bring science into the discussion. So this would be a challenge for 2017. Who is coming up with scientific proof that LASIK Xtra works?
Small incision lenticule extraction (SMILE) has become one of the top issues in refractive surgery. The possibility to use only one femtosecond laser for all refractive surgery, avoiding excimer costs, is attractive on top of the minimal invasiveness of the procedure.
However, SMILE has not yet been demonstrated to be superior to LASIK or to provide evidence about its better performance than excimer laser surgery. This is indeed an obstacle to its progression and, in my case, an obstacle for patients to choose the technique as it is less known.
Following the innovation that came with the invention of SMILE, now is the time to bring evidence about its superiority or not. If not superior, then SMILE will have the advantage of costs as once the hyperopia is accomplished, one femtosecond laser will fit all corneal procedures, including refractive ones.
Consolidation or expansion?
I am an ophthalmic CEO-a doctor who is a manager at the same time. The LASIK market in 2016 was extremely good compared with the years before and we all know that LASIK is consumer-behaviour depending.
Our initial plan for 2017 was expansion: Investing in new technologies, new lasers, new therapies, hiring more doctors, and developing new offices.
With the election result of the United States in 2016 and the inauguration of the new US goverment in 2017 there is uncertainty coming up. It might be good for the US; it can be very bad for Europe. As a CEO, I have the responsibility to analyse the situation and foresee what might come up.
My conclusion is to wait and see. I will postpone all investments for at least 6 months and see what is going to happen. So this is the business challenge in 2017. Consolidation has priority over expansion and growth.
Dr Jorge Alio
Dr Albert J Augustin
Dr Augustin declares no financial interests.
Dr Gábor Holló
Dr Holló declares interests with Alcon Laboratories, Optovue, and Santen.
Dr med Omid Kermani
Dr Kermani declares no financial interests.
Dr Einar Stefánsson
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.