OSN Europe: Advances in IOL technology lead to better results, patient-customized options

A new generation of premium lenses promises to offer opportunities for increasingly accurate refraction, customized to the individual patient.

“It is a changing scenario in which cataract and refractive lens exchange (RLE) patients can expect considerably better results, major advantages and fewer problems. It is going to be an exciting time, with a lot of innovation in technologies, a brighter future for the patients and expansion for the market,” Jorge L. Alió, MD, PhD, OSN Europe Edition Board Member, said.

The growing market of multifocal IOLs currently offers two main options. On one hand there is a variety of innovative-design diffractive implants, and on the other hand, a new type of refractive varifocal optics.

The Lentis Mplus is the main lens in the varifocal group and is part of a family of lenses developed by Oculentis that focuses on patient selection.

“Patients are classified as dominant for far, intermediate or near, according to their lifestyle requirements,” Alió explained.

The Mplus family IOLs are asymmetric, with a sector-shaped near vision zone, the same plate haptics but different additions.

The first Lentis Mplus had a 3 D addition, and then a new member of the family, the Mplus X, was created for better near vision.

“I strongly advocated this change because I found that the near add was not satisfactory enough, particularly for women. The sector for near vision was enlarged, the transition zone was optimized, a new central aspheric optic part was included, and now patients are able to read small print without glasses,” Magda Rau, MD, OSN Europe Edition Board Member, said.

Another option offered by Oculentis is the Lentis Comfort, with an addition of 1.5 D. The lower addition sacrifices some near vision but minimizes glare and halos.

“I like to offer this lens to men, who tend to be intolerant to halos and glare and wish in spite of that independence from glasses. I usually start by implanting this lens in the dominant eye, and if the patient is satisfied, I implant the same lens in the second eye. If more near vision is wanted, I implant the Mplus with 2 D or 3 D addition,” Rau said.

The Lentis Mplus toric is individually custom made in a large range for sphere from 0 D to 36 D and for cylinder from 0.25 D to 12 D. It is available in 0.01 D steps to enable the correction of sphere, astigmatism and presbyopia.

“Until now, I have indicated the Lentis Mplus toric up to 1.5 D of astigmatism, but now if the patient can afford it, I also use it to correct low astigmatism, like 0.75 D to 1 D, because this improves VA especially for distance but also intermediate and near,” Rau said.

“There is also a model for low vision in the Mplus family, which is going to make quite a difference in the lives of patients with AMD who still have sufficient near vision. They are going to be able to read in better conditions and do away with the problems related to spectacles and magnifiers,” Alió said.

Another model for specific needs is the myLENTIS, currently under investigation in a European multicenter trial.

“It is not a multifocal, but focuses on ocular aberrations and specifically aims at patients who have had previous corneal refractive surgery, particularly patients operated years ago with primitive models of lasers or lasers that have been used by inadequate hands. An emerging group who need correction of ametropia but also correction of aberrations. Keratoconus patients are also candidates,” Alió said.

The lens will be custom made for individual patients.

Trifocal optics

Damien Gatinel, MD, PhD, was involved in the development of the first trifocal IOL, the FineVision (PhysIOL), released on the market in 2010.

“What made me think of this lens was that my patients 10 years ago could see well at distance and were able to read, but had trouble using screens. Computer vision was already what they needed most. Computers, smartphones and iPads have now become an integral part of daily life, and the most commonly used reading distance required by our patients is 60 cm to 70 cm. To become spectacle independent, you currently need intermediate vision,” Gatinel said. There are no disadvantages in trifocal optics, no more halos and glare than in bifocal IOLs, and no more difficulty in IOL power calculation, he said.

“Whenever you can put a bi, you can put a tri,” he said.

The first FineVision was originally designed with four haptics. When the company decided to introduce a toric model, the design was modified for increased stability. The new double C-loop Pod F is now available as a toric as well as a regular trifocal IOL.

Gatinel uses premium multifocal IOLs, mainly trifocal, in 10% to 15% of his patients. This accounts for about 100 patients per year.

“It is a growing percentage. It creates a lot of word of mouth, and all my patients come from recommendations of satisfied patients,” he said.

Other trifocal IOLs include the Alcon AcrySof IQ PanOptix, the Zeiss At Lisa tri and the VSY Acriva Reviol. The latter has a special design aimed at providing superior modulation transfer function values in the transition areas for seamless continuous vision and larger depth of focus.

“This lens is a welcome addition to the family of trifocals,” Pavel Stodulka, MD, PhD, OSN Europe Edition Board Member, said.

He has implanted about 50 of these lenses and is assessing the results, which look promising. The mean uncorrected near visual acuity is J 1.3, which allows people to read even very small print. More than 90% of his patients have gained spectacle independence over the first 6 months of follow-up.

Extended range of vision

Extended depth of focus and reduction of diffractive phenomena are goals of the Tecnis Symfony (Abbott Medical Optics), “an entirely different concept and a truly new-generation IOL,” according to Aylin Kiliç, MD.

“Other multifocal lenses, including trifocals, focus at different points, and in the transitions between these points, vision loses clarity. The echelette design of the Symfony provides elongation of focus, resulting in extended depth of vision without transition zones. This translates into smooth-vision pseudoaccommodation, with no halos and glare,” she said.

The achromatic technology in the Symfony also compensates for chromatic aberration and color distortion, enhancing contrast sensitivity.

Early results showed that out of 200 eyes, 75 achieved 20/20 or better with the Symfony. Mean intermediate vision was also 20/20, and near vision was in the range of 20/32.

“My personal follow-up is limited to 3 months, and I only implanted nine patients, post-LASIK cataract, cataract and RLE. All patients achieved distance acuity of more than 20/20, can read small print, and use computers, tablets and smartphones without glasses. None has complaints of halos and glare. One patient said he can see really sharp without his glasses,” Kiliç said.

Post-LASIK patients are an important test, she said. They want perfection, and a multifocal lens behind a multifocal cornea does not perform well and reduces contrast.

“In my patients, there were no refractive surprises, and binocular vision was very good, beyond my expectations,” she said.

Polyfocality and multifocal monovision

The WIOL-CF (Medicem) is still another multifocal system, renamed as “polyfocal.”

“The real difference is the design,” Ioannis G. Pallikaris, MD, PhD, OSN Europe Edition Board Member, said. “A polyfocal optic has no rings, is uniform, but from center to periphery, the optic power continuously changes. It generates a kind of multifocality with a very big depth of focus. Glare problems are overcome, and the effect is huge, 5 D to 7 D. Of course, some compromise with quality of vision has to be expected.”

The manufacturers aimed at creating a bioanalogic implant, close to the size, shape and texture of the human lens. It has no haptics and fills the capsule 90% because it increases in volume by hydration. The posterior curvature is close to the human lens curvature, leading to less formation of posterior capsule opacification, Pallikaris said. Another area of interest is the multifocal monovision approach, which Pallikaris obtains by combining an intracorneal inlay with a monofocal aspheric IOL.

“I have been using the Presbia Flexivue inlay for years, and now some of the patients have started to develop cataract. I leave the inlay in the cornea, and after IOL implantation, this eye has a kind of multifocal effect. These patients are used to living with multifocality. For them it is not something new because their brain has adapted. Now I have started using this system also in virgin eyes,” Pallikaris said.

Accommodating IOLs are ultimate goal

Even though previous accommodating IOL models had limited success, the new generation of lenses may be the future of presbyopia correction, according to Alió.

“Multifocals are not the end of the story. What we need is real accommodation. Once accommodative IOLs are developed adequately, multifocal IOLs will be unable to compete,” he said.

Multifocal optics, he said, will always require some degree of adaptation, and there will always be some dissatisfied patients “because our brain is not a multifocal brain, but a monofocal brain.”

New accommodating IOL models include in-the-bag technologies, such as the FluidVision (PowerVision) and the Sapphire (Elenza), as well as in-the-sulcus models, such as the DynaCurve (NuLens) and the Lumina (Akkolens/Oculentis).

Sulcus-implanted lenses are a better concept, according to Alió, because the capsular bag naturally develops fibrosis and atrophy once it is emptied, and there are no functions and no anatomical reasons for it to exist.

“The structural source of kinetic energy is the anterior capsule, which generates axial, centripetal and centrifugal forces that we can exploit to re-establish accommodation,” he said.

In the Lumina lens, power changes are produced by two elements shifting in the plane perpendicular to the optical axis. In a pilot study, the lens was implanted in 50 eyes, and results were compared with those of a standard monofocal IOL.

“The lens showed good results, with evidence of accommodation between 1.5 D and 6 D by objective WAM measurements and subjective defocus curve at 6 months,” Alió said.

“The multifocal concept has undergone major advances and fulfills 70% of the needs of our patients. However, it is still a compromise solution. My belief is that accommodation with a lens that can adjust the power at any given distance is the ultimate goal,” Pallikaris said.

“I am very deep into this concept, trying to understand and design a truly accommodative lens, which will be guided by the capsule and not the ciliary body. Real accommodation has to restart in a capsule that is revitalized,” he said. — by Michela Cimberle

References:

Alió JL, et al. J Refract Surg. 2013;doi:10.3928/1081597X-20131021-05.

Alió JL, et al. J Refract Surg. 2013;doi:10.3928/1081597X-20130318-04.

Cochener B, et al. J Refract Surg. 2014;doi:10.3928/1081597X-20141021-08.

Gatinel D, et al. J Cataract Refract Surg. 2011;doi:10.1016/j.jcrs.2011.05.047.

Gatinel D, et al. J Cataract Refract Surg. 2013;doi:10.1016/j.jcrs.2013.01.048.

Pallikaris IG, et al. J Refract Surg. 2014;doi:10.3928/1081597X-20140520-01.

Plaza-Puche AB, et al. J Refract Surg. 2015;doi:10.3928/1081597X-20150423-03.

For more information:

Jorge L. Alió, MD, PhD, can be reached at Vissum Corporation, Avenida de Denia, s/n, 03016 Alicante, Spain; email: jlalio@vissum.com.

Damien Gatinel, MD, PhD, can be reached at Fondation Rothschild, 25 Rue Manin, 75019 Paris, France; email: gatinel@gmail.com.

Aylin Kılıç, MD, can be reached at Dünyagöz Eye Hospital, Istanbul, Turkey; email: aylinkilicdr@gmail.com.

Click here to read the full cover story published in Ocular Surgery News Europe Edition, July/August 2015.

A new generation of premium lenses promises to offer opportunities for increasingly accurate refraction, customized to the individual patient.

“It is a changing scenario in which cataract and refractive lens exchange (RLE) patients can expect considerably better results, major advantages and fewer problems. It is going to be an exciting time, with a lot of innovation in technologies, a brighter future for the patients and expansion for the market,” Jorge L. Alió, MD, PhD, OSN Europe Edition Board Member, said.

The growing market of multifocal IOLs currently offers two main options. On one hand there is a variety of innovative-design diffractive implants, and on the other hand, a new type of refractive varifocal optics.

The Lentis Mplus is the main lens in the varifocal group and is part of a family of lenses developed by Oculentis that focuses on patient selection.

“Patients are classified as dominant for far, intermediate or near, according to their lifestyle requirements,” Alió explained.

The Mplus family IOLs are asymmetric, with a sector-shaped near vision zone, the same plate haptics but different additions.

The first Lentis Mplus had a 3 D addition, and then a new member of the family, the Mplus X, was created for better near vision.

“I strongly advocated this change because I found that the near add was not satisfactory enough, particularly for women. The sector for near vision was enlarged, the transition zone was optimized, a new central aspheric optic part was included, and now patients are able to read small print without glasses,” Magda Rau, MD, OSN Europe Edition Board Member, said.

Another option offered by Oculentis is the Lentis Comfort, with an addition of 1.5 D. The lower addition sacrifices some near vision but minimizes glare and halos.

“I like to offer this lens to men, who tend to be intolerant to halos and glare and wish in spite of that independence from glasses. I usually start by implanting this lens in the dominant eye, and if the patient is satisfied, I implant the same lens in the second eye. If more near vision is wanted, I implant the Mplus with 2 D or 3 D addition,” Rau said.

The Lentis Mplus toric is individually custom made in a large range for sphere from 0 D to 36 D and for cylinder from 0.25 D to 12 D. It is available in 0.01 D steps to enable the correction of sphere, astigmatism and presbyopia.

“Until now, I have indicated the Lentis Mplus toric up to 1.5 D of astigmatism, but now if the patient can afford it, I also use it to correct low astigmatism, like 0.75 D to 1 D, because this improves VA especially for distance but also intermediate and near,” Rau said.

“There is also a model for low vision in the Mplus family, which is going to make quite a difference in the lives of patients with AMD who still have sufficient near vision. They are going to be able to read in better conditions and do away with the problems related to spectacles and magnifiers,” Alió said.

Another model for specific needs is the myLENTIS, currently under investigation in a European multicenter trial.

“It is not a multifocal, but focuses on ocular aberrations and specifically aims at patients who have had previous corneal refractive surgery, particularly patients operated years ago with primitive models of lasers or lasers that have been used by inadequate hands. An emerging group who need correction of ametropia but also correction of aberrations. Keratoconus patients are also candidates,” Alió said.

The lens will be custom made for individual patients.

PAGE BREAK

Trifocal optics

Damien Gatinel, MD, PhD, was involved in the development of the first trifocal IOL, the FineVision (PhysIOL), released on the market in 2010.

“What made me think of this lens was that my patients 10 years ago could see well at distance and were able to read, but had trouble using screens. Computer vision was already what they needed most. Computers, smartphones and iPads have now become an integral part of daily life, and the most commonly used reading distance required by our patients is 60 cm to 70 cm. To become spectacle independent, you currently need intermediate vision,” Gatinel said. There are no disadvantages in trifocal optics, no more halos and glare than in bifocal IOLs, and no more difficulty in IOL power calculation, he said.

“Whenever you can put a bi, you can put a tri,” he said.

The first FineVision was originally designed with four haptics. When the company decided to introduce a toric model, the design was modified for increased stability. The new double C-loop Pod F is now available as a toric as well as a regular trifocal IOL.

Gatinel uses premium multifocal IOLs, mainly trifocal, in 10% to 15% of his patients. This accounts for about 100 patients per year.

“It is a growing percentage. It creates a lot of word of mouth, and all my patients come from recommendations of satisfied patients,” he said.

Other trifocal IOLs include the Alcon AcrySof IQ PanOptix, the Zeiss At Lisa tri and the VSY Acriva Reviol. The latter has a special design aimed at providing superior modulation transfer function values in the transition areas for seamless continuous vision and larger depth of focus.

“This lens is a welcome addition to the family of trifocals,” Pavel Stodulka, MD, PhD, OSN Europe Edition Board Member, said.

He has implanted about 50 of these lenses and is assessing the results, which look promising. The mean uncorrected near visual acuity is J 1.3, which allows people to read even very small print. More than 90% of his patients have gained spectacle independence over the first 6 months of follow-up.

Extended range of vision

Extended depth of focus and reduction of diffractive phenomena are goals of the Tecnis Symfony (Abbott Medical Optics), “an entirely different concept and a truly new-generation IOL,” according to Aylin Kiliç, MD.

“Other multifocal lenses, including trifocals, focus at different points, and in the transitions between these points, vision loses clarity. The echelette design of the Symfony provides elongation of focus, resulting in extended depth of vision without transition zones. This translates into smooth-vision pseudoaccommodation, with no halos and glare,” she said.

The achromatic technology in the Symfony also compensates for chromatic aberration and color distortion, enhancing contrast sensitivity.

Early results showed that out of 200 eyes, 75 achieved 20/20 or better with the Symfony. Mean intermediate vision was also 20/20, and near vision was in the range of 20/32.

“My personal follow-up is limited to 3 months, and I only implanted nine patients, post-LASIK cataract, cataract and RLE. All patients achieved distance acuity of more than 20/20, can read small print, and use computers, tablets and smartphones without glasses. None has complaints of halos and glare. One patient said he can see really sharp without his glasses,” Kiliç said.

Post-LASIK patients are an important test, she said. They want perfection, and a multifocal lens behind a multifocal cornea does not perform well and reduces contrast.

“In my patients, there were no refractive surprises, and binocular vision was very good, beyond my expectations,” she said.

PAGE BREAK

Polyfocality and multifocal monovision

The WIOL-CF (Medicem) is still another multifocal system, renamed as “polyfocal.”

“The real difference is the design,” Ioannis G. Pallikaris, MD, PhD, OSN Europe Edition Board Member, said. “A polyfocal optic has no rings, is uniform, but from center to periphery, the optic power continuously changes. It generates a kind of multifocality with a very big depth of focus. Glare problems are overcome, and the effect is huge, 5 D to 7 D. Of course, some compromise with quality of vision has to be expected.”

The manufacturers aimed at creating a bioanalogic implant, close to the size, shape and texture of the human lens. It has no haptics and fills the capsule 90% because it increases in volume by hydration. The posterior curvature is close to the human lens curvature, leading to less formation of posterior capsule opacification, Pallikaris said. Another area of interest is the multifocal monovision approach, which Pallikaris obtains by combining an intracorneal inlay with a monofocal aspheric IOL.

“I have been using the Presbia Flexivue inlay for years, and now some of the patients have started to develop cataract. I leave the inlay in the cornea, and after IOL implantation, this eye has a kind of multifocal effect. These patients are used to living with multifocality. For them it is not something new because their brain has adapted. Now I have started using this system also in virgin eyes,” Pallikaris said.

Accommodating IOLs are ultimate goal

Even though previous accommodating IOL models had limited success, the new generation of lenses may be the future of presbyopia correction, according to Alió.

“Multifocals are not the end of the story. What we need is real accommodation. Once accommodative IOLs are developed adequately, multifocal IOLs will be unable to compete,” he said.

Multifocal optics, he said, will always require some degree of adaptation, and there will always be some dissatisfied patients “because our brain is not a multifocal brain, but a monofocal brain.”

New accommodating IOL models include in-the-bag technologies, such as the FluidVision (PowerVision) and the Sapphire (Elenza), as well as in-the-sulcus models, such as the DynaCurve (NuLens) and the Lumina (Akkolens/Oculentis).

Sulcus-implanted lenses are a better concept, according to Alió, because the capsular bag naturally develops fibrosis and atrophy once it is emptied, and there are no functions and no anatomical reasons for it to exist.

“The structural source of kinetic energy is the anterior capsule, which generates axial, centripetal and centrifugal forces that we can exploit to re-establish accommodation,” he said.

In the Lumina lens, power changes are produced by two elements shifting in the plane perpendicular to the optical axis. In a pilot study, the lens was implanted in 50 eyes, and results were compared with those of a standard monofocal IOL.

“The lens showed good results, with evidence of accommodation between 1.5 D and 6 D by objective WAM measurements and subjective defocus curve at 6 months,” Alió said.

“The multifocal concept has undergone major advances and fulfills 70% of the needs of our patients. However, it is still a compromise solution. My belief is that accommodation with a lens that can adjust the power at any given distance is the ultimate goal,” Pallikaris said.

“I am very deep into this concept, trying to understand and design a truly accommodative lens, which will be guided by the capsule and not the ciliary body. Real accommodation has to restart in a capsule that is revitalized,” he said. — by Michela Cimberle

References:

Alió JL, et al. J Refract Surg. 2013;doi:10.3928/1081597X-20131021-05.

Alió JL, et al. J Refract Surg. 2013;doi:10.3928/1081597X-20130318-04.

Cochener B, et al. J Refract Surg. 2014;doi:10.3928/1081597X-20141021-08.

Gatinel D, et al. J Cataract Refract Surg. 2011;doi:10.1016/j.jcrs.2011.05.047.

Gatinel D, et al. J Cataract Refract Surg. 2013;doi:10.1016/j.jcrs.2013.01.048.

Pallikaris IG, et al. J Refract Surg. 2014;doi:10.3928/1081597X-20140520-01.

Plaza-Puche AB, et al. J Refract Surg. 2015;doi:10.3928/1081597X-20150423-03.

For more information:

Jorge L. Alió, MD, PhD, can be reached at Vissum Corporation, Avenida de Denia, s/n, 03016 Alicante, Spain; email: jlalio@vissum.com.

Damien Gatinel, MD, PhD, can be reached at Fondation Rothschild, 25 Rue Manin, 75019 Paris, France; email: gatinel@gmail.com.

Aylin Kılıç, MD, can be reached at Dünyagöz Eye Hospital, Istanbul, Turkey; email: aylinkilicdr@gmail.com.

Click here to read the full cover story published in Ocular Surgery News Europe Edition, July/August 2015.