Phakic IOLs have reduced but still important role in European ophthalmology

Brought to the market in the late 1980s, phakic IOLs promised to be the solution for patients with high refractive error who were not eligible for corneal laser surgery. The initial enthusiasm cooled down in the following years due to long-term sight-threatening complications that induced companies to repeatedly modify some of the existing IOL designs and eventually withdraw several models from the market.

Although the use of phakic IOLs did not expand as much as was expected at first, this technology still has a well-established role, according to Antonio Marinho, MD, PhD, OSN Europe Edition Board Member.

“They are still the gold standard and the only way to correct high ametropia. Corneal laser techniques, including SMILE, cannot compete with them when it comes to high refractive error,” he said. “I have not lost my enthusiasm in this technology.”

The loss of popularity that came from complications and discontinuation of some phakic IOLs contributed to the negative trend regarding refractive surgery as a whole, OSN Europe Edition Board Member Camille Budo, MD, said.

“But the good news coming from Ophtec, manufacturer of iris-claw lenses, is that the sales of the Artisan/Artiflex toric are steadily going up. I believe that the range of opportunities for phakic IOLs is increasing, as the limitations of laser become obvious. More patients are looking now for a reversible procedure, and multiple long-term results with the Artisan/Artiflex have shown they are a safe and effective technology,” he said.

Having learned from experience and having new means for measuring the eye, such as OCT scans, surgeons can now rely on more precise criteria for patient selection. Indications for phakic IOLs have narrowed and results are better, Budo said.

Image: Marinho A

Niche procedure

Francesco Carones, MD, OSN Europe Edition Board Member, sees phakic IOLs as a niche procedure.

“The numbers are low, and I don’t see they will ever grow again,” he said.

One reason, in his view, is that surgery is challenging, more than cataract and certainly more than laser, and complications can be devastating. With phakic IOLs, the worst-case scenario can be dramatic, up to complete vision loss in case of endophthalmitis. Cost is also an issue. Some patients counseled for this solution do not proceed with it because of financial limitations.

“I discuss for a long time with my patients the possibility of implanting these lenses, and my approach is very cautious. Benefits are really high, they provide a significantly better quality of vision than spectacles, but I do not recommend them to patients who are still tolerant to contact lenses,” Carones said.

He believes that phakic IOLs should be presented as a temporary solution, as “a bridge between today and the age of cataract surgery.”

“I also tell my patients that complications may develop even many years after implantation, that one day they might be in my office seeing 20/20 or even better but I’ll have to remove the IOL,” he said.

Posterior chamber ICL

Two models of phakic IOLs have stood the test of time: the posterior chamber ICL (STAAR Surgical) and the anterior chamber iris-claw Artisan/Artiflex (Ophtec).

According to the Global Strategic Business Report 2015-2020, the Visian ICL currently dominates the global phakic IOL market.

“I implanted the ICL 15 years ago and then stopped because of the high incidence of cataract. I came back to this technology when the central hole, the Aquaport, was introduced, and now I am very happy,” Marinho said.

The central hole, 360 µm in diameter, allows a more natural flow of the aqueous between the IOL and the crystalline lens, and helps to prevent IOP increase and cataract formation.

“The biggest issue in my view is not cataract, but the sudden IOP raise that is devastating,” Carones said. “My advice is to spend a little more but no longer implant the model without Aquaport. It makes surgery a lot safer, with no disadvantages, no additional halos or aberrations.”

The problem with the ICL is sizing, which is not well established and relies on the white-to-white measurement.

“It may correspond to the sulcus-to-sulcus in about 85% of the cases, but there is still 15% where it does not,” Marinho said.

Successful ICL implantation starts with inclusion criteria related to anterior chamber depth and configuration of the iris and angle.

“Even if you think that the ICL is far from the endothelium and that the anterior chamber does not matter, it matters, and eye anatomy and configuration should be carefully studied with the OCT,” Marinho said.

Surgery should be as gentle and precise as possible to avoid traumatizing the lens and the angle.

“Remember that this surgery is different from cataract surgery. The injection of the ICL needs to be very slow to allow the lens to unfold slowly and not turn upside down,” Marinho said.

Surgeons who approach this technology for the first time must be cautions, according to Carones.

“It is a very difficult surgery, and risks are higher than in cataract surgery. It is not at all a forgiving procedure, and potential complications are challenging. Never do it alone for the first time. Have someone who is expert next to you in the OR,” Carones said.

Iris-claw Artisan/Artiflex

Budo started implanting the Artisan lens in 1988, went on to the foldable Artiflex and has performed approximately 5,300 iris-claw implantations.

“What I like about this lens is that it is a 100% surgeon-dependent lens. The surgeon is responsible for the indications, for the preoperative examinations, for the surgery, for the centration of the lens, the enclavation and quantity of iris tissue, and for the postoperative assessment. There are no surprises following successful surgery,” he said.

He recommended attending the Artisan/Artiflex training courses before approaching this surgery alone. Careful preoperative examination, including anterior chamber OCT imaging, should establish whether there is sufficient anterior chamber depth and a preoperative crystalline lens rise less than 600 µm. It is mandatory to exclude patients who do not perfectly fit the surgery profile.

“During surgery, only use appropriate instrumentation and a cohesive OVD, washing it out carefully at the end of the procedure. Before or during surgery, perform peripheral iridotomy. It is a safety belt for us to prevent postoperative Urrets-Zavalia syndrome,” he said.

Close monitoring after implantation is mandatory. Budo continues to see his patients who were implanted long ago once a year for an endothelial cell count and to evaluate the progression of crystalline lens rise.

Angle-supported lenses

Carones implanted a significant number of angle-supported IOLs between 2008 and 2014, when Alcon voluntarily withdrew the Cachet implant from the market due to concerns about abnormally high endothelial cell loss in some patients.

“One of the biggest advantages of these lenses was that they were easy to implant and very easy to remove. From this perspective, they were quite safe because second surgery is not challenging,” he said.

The reason why late complications occurred is still unclear.

“It was nothing related to the shape, material or concept of the lens. The majority of patients did and still do very well, and it was just a matter of unpredictable, random cases doing differently from the majority. I still monitor these patients. They come once every 6 months, and I had no case of endothelial decompensation,” Carones said.

According to Marinho, the protocol for the Cachet included patients with shallow anterior chambers, and this was the mistake that led to complications.

He implanted the lens in 112 eyes, has a follow-up of 7 years and explanted only three lenses, all due to dislocation and not endothelial problems.

However, all three surgeons agreed that there is no future for the angle-supported concept.

“Their reputation went so low that no company will ever invest again in these lenses and no surgeon would be willing to try them again,” Carones said.

“Already in the late ’90s some of us thought that angle-supported would be the disaster of the 21st century,” Budo said.

Newcomers

A novel posterior chamber phakic IOL, the Implantable Phakic Contact Lens (IPCL), was recently developed by the Indian company Care Group and is currently available in Europe.

“Today, the IPCL is our implant of choice,” Pavel Stodulka, MD, PhD, OSN Europe Edition Board Member, said. “We use the EyePCL model marketed in Europe by Eyeol UK, based in London. It is made of hydrophilic acrylic, it maintains the vault very reliably, and the great advantage is that it can be delivered through a 1.8-mm incision. Our experience with about 100 implants in over 2 years has been very positive.”

The lens is available for myopia and hyperopia in a toric model and also in a presbyopic version, which incorporates diffractive technology in the anterior optic surface to provide myopic correction together with near addition for reading.

“At first we used this presbyopic implant for low hyperopic patients, 45 to 50 years of age. Today we use it mostly for myopes of –5 D or more, from the age of 40 or even 35, when they are not good candidates for LASIK. They will not make any use of the diffractive component of the lens while they retain accommodation, but once they start becoming presbyopic, the brain will automatically select it for reading and no spectacles will be needed. A very appealing option for a lot of high myopes at the age of 35 to 40,” Stodulka said.

Halos are much less compared with the presbyopic lenses used for cataract surgery, perhaps because the crystalline lens filters the light, he said.

Other manufacturers are currently developing presbyopic phakic lenses.

“An Artiflex presbyopic phakic IOL may be suitable for patients between 50 and 60+, a good alternative to clear lens exchange, overcoming the downsides of this procedure. We hope that we can start with this new experience in the near future,” Budo said. – by Michela Cimberle

• References:
• Alió JL, et al. J Refract Surg. 2015;doi:10.3928/1081597X-20141202-01.
• Alió JL, et al. JAMA Ophthalmol. 2013;doi:10.1001/jamaophthalmol.2013.5595.
• Baïkoff G, et al. J Cataract Refract Surg. 2005;doi:10.1016/j.jcrs.2004.09.034.
• Barsam A, et al. Cochrane Database Syst Rev. 2014;doi:10.1002/14651858.CD007679.pub4.
• Budo C. J Cataract Refract Surg. 2010;doi:10.1016/j.jcrs.2010.07.008.
• Doors M, et al. Am J Ophthalmol. 2012;doi:10.1016/j.ajo.2012.04.006.
• Guber I, et al. JAMA Ophthalmol. 2016;doi:10.1001/jamaophthalmol.2016.0078.
• Kohnen T, et al. J Cataract Refract Surg. 2010;doi:10.1016/j.jcrs.2010.10.007.
• Morral M, et al. J Cataract Refract Surg. 2016;doi:10.1016/j.jcrs.2015.08.018.
• Ostovic M, et al. J Cataract Refract Surg. 2013;doi:10.1016/j.jcrs.2013.02.005.
• Shimizu K, et al. Medicine (Baltimore). 2016;doi:10.1097/MD.0000000000003270.

• For more information:
• Camille Budo, MD, is emeritus associate professor of ophthalmology at the University of Maastricht, The Netherlands. He can be reached at Hasseltsesteenweg 40-B 3800 Sint-Truiden, Belgium; email: camille.budo@gmail.com.
• Francesco Carones, MD, is medical director of Centro Oftalmo-Chirurgico Carones in Milan, Italy. He can be reached at email: fcarones@carones.it.
• Antonio Marinho, MD, PhD, is chairman of the Department of Ophthalmology, Hospital Arrábida, Porto, Portugal. He can be reached at email: marin@mail.telepac.pt.
• Pavel Stodulka, MD, PhD, is chairman and CEO of Gemini Eye Clinics Zlin/Prague, Czech Republic. He can be reached at email: stodulka@lasik.cz.

Disclosures: Budo reports he is a medical monitor and consultant to Ophtec. Carones reports he is a consultant to Alcon, Abbott, WaveLight and AcuFocus. Marinho reports he is a consultant to Ophtec and Alcon. Stodulka reports he is a consultant to Excel-Lens and Bausch + Lomb.

How would you treat a 47-year-old patient with myopia of –7 D and corneal thickness below 500 µm who has become contact lens intolerant and wants to be spectacle independent?

Clear lens exchange with implantation of a multifocal lens

When dealing with failing accommodation but a healthy crystalline lens, the decision to perform clear lens exchange is never straightforward. But on the other hand, there are not many options we can offer to a patient with medium to high myopia and a thin cornea. ICL implantation (STAAR) with undercorrection of 1D to 1.5 D in the non-dominant eye may be an alternative, but the patient should know that this is a temporary solution because presbyopia increases with aging and in most cases, within 10 to 12 years, this phakic lens causes cataract and has to be removed. The company has promised a lower incidence of cataract with the new Visian with Aquaport, but we do not have long-term follow-up to be sure of this result. Cost, which is about 1,200 for one lens, may be another issue. When I present to my patients the two options of ICL or clear lens exchange with implantation of a multifocal lens and let them choose, most of them prefer to go for the one that is done once and forever. Personally, this is also the option I would prefer in a patient who needs to recover distance vision and wishes to have spectacle-free reading vision. I would carefully select the type of lens based on profession, hobbies, driving, reading habits and expectations of the patient, with an attention to gender differences. Considering all parameters, I mostly implant the FineVision trifocal (PhysIOL) in women and the asymmetric Lentis (Oculentis) in men.

Magda Rau, MD, is OSN Europe Edition Assistant Editor and head of Augenklinik Cham, Cham, Germany. Disclosure: Rau reports no relevant financial disclosures.

Monovision with phakic IOLs

I could possibly consider clear lens exchange in a patient with these characteristics if the crystalline lens presented alterations and aberrations. Otherwise, I would rather go for monovision by implantation of phakic IOLs of slightly different powers, setting the dominant eye for distance and the non-dominant eye for near. I would preferably implant an ICL (STAAR), which is a relatively easy office-based procedure to perform under topical anesthesia through a sutureless incision. This lens provides excellent visual quality, is well tolerated and has almost no complications. Should the patient develop cataract at an older age, the ICL can be easily explanted to perform phaco with implantation of a multifocal or trifocal IOL. Another interesting option might be the IPCL, a presbyopic phakic lens produced by Care Group. I have seen several good reports on this lens. STAAR Surgical is currently developing its own presbyopic model, which might be on the market within 6 months to 1 year. These options will definitely expand the use of phakic IOLs to young presbyopes, offering the advantages of a reversible procedure.

Lucio Buratto, MD, is an OSN Europe Edition Board Member and director of Centro Ambrosiano Oftalmico, Milan, Italy. Disclosure: Buratto reports he is a consultant to Abbott Medical Optics, Zeiss, Alcon and Technolas.