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Phakic lens offers new option for presbyopia correction
A novel lens manufactured in India may be the ‘missing link’ for phakic patients with thin corneas.
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A novel posterior chamber phakic IOL may provide correction for presbyopia, as well as myopia and astigmatism. According to Luis Salvà Ladaria, MD, and Scott Anderson García, MD, ophthalmologists in Palma de Mallorca, Spain, it is “the missing link” within the options for presbyopia.
“We have, alone or in combination, several laser options, refractive lensectomy, corneal inlays and even eye drops, but a phakic IOL had not yet been proposed,” Salvà said in an interview with Ocular Surgery News.
The new Implantable Phakic Contact Lens (IPCL, Care Group) was designed by Indian engineers, based on extensive experience with the Visian ICL (STAAR Surgical). With more than 500,000 implantations performed worldwide in 20 years of commercial availability, the ICL has marked a milestone in IOL technology, providing solid evidence of safety, reversibility, ease of implantation, stability of results and ability to correct high ametropia.
“The IPCL emerges as a new twist to a well-established concept, with further improvements in terms of design, material, dioptric range and the entirely new multifocal option (IPCL Presbyopia),” Salvà said.
The lens
Made of hydrophilic acrylic material that is 100% porcine collagen free, the IPCL is designed to have six points of contact, instead of four, with the ciliary sulcus for improved stability. It has two positioning holes in the haptics to facilitate implantation and four holes in the optic periphery to allow aqueous flow without causing a disturbance to vision.
“Injection is easy and reproducible with a normal injector by Medicel. With ICLs, sometimes there are difficulties because the lens tends to turn upside down, but this lens is made of an acrylic material that is relatively harder and easy to handle into the eye and to place in the appropriate position,” Salvà said.
Luis Salvà Ladaria
The IPCL Presbyopia has a diffractive optical zone of 3.5 mm in diameter, which allows a soft sliding of the iris over the lens and aims at reducing halos. It is available with additions between +1.5 D and +3.5 D, in steps of 0.5 D.
Panfocality
This new phakic lens for presbyopia introduces a new way of restoring accommodation, which Salvà defined as “panfocality.”
“It’s not just the bifocality or trifocality offered by aphakic IOLs because the IPCL interacts with the crystalline lens and enhances the patient’s residual accommodation,” he said.
“When we perform lensectomy and implant a multifocal IOL, we only have the help of the artificial lens to see for near, but in this particular case, there is a combination of two lenses: a diffractive lens, which is the IPCL, and the natural crystalline lens.”
IPCL implanted in a patient.
Image: Salvá Ladaria L
Because it is a new concept, panfocality requires a different approach to preoperative assessment, including the measurement of residual accommodation and binocularity status. IPCL power calculation is done by the manufacturers in India, based on individual patient data.
“In the near future, we should have algorithms and calculators we can use independently. The IPCL has very flexible parameters in terms of diameter, optical zones and dioptric power. You can do mix-and-match or choose monovision. You can play with a lot of variables to achieve the best vision for near and far,” Salvà said.
The possibility of experiencing mild visual phenomena has to be taken into account when proposing this lens to the patient, but no more than with any other multifocal lens.
“The main advantage of this lens is the possibility to correct presbyopia reversibly, in addition to spherical and cylindrical error correction, in a single step. And it is a way we can offer surgery also to patients with thin corneas. In our opinion, the ideal target for this lens is the group of patients from 40 to 55 years of age who have not yet developed cataract,” Salvà said.
Early results
In a small study, Salvà and García evaluated the safety parameters and visual results of the lens by implanting three patients with a monofocal IPCL in one eye and a standard ICL in the other eye. Preliminary results showed no differences in visual acuity, except in one case in which the target refraction could not be achieved in the ICL eye because there was no commercially available lens with the required dioptric power. There were no intraoperative complications, and none of the patients had complaints about halos or neuroadaptation problems.
“We also have a small 3-month personal experience with the IPCL for presbyopia, which we implanted in three bilateral cases. We used the mix-and-match approach to be able to achieve the best in intermediate vision, as well as good and stable near vision, because seeing well at intermediate is increasingly necessary in the everyday life of most patients,” Salvà said.
More cases, more experience and further results are needed, and refinement in the implantation and power calculation strategies will be the key to future success, he said.
The IPCL is widely used in India and is now commercially available in Europe, where several patients have been implanted in Spain and some other countries. – by Michela Cimberle
- For more information:
- Luis Salvà Ladaria, MD, is the head of Oftalmedic Clínica Salvà in Palma de Mallorca, Spain; email: lsalva@oftalmedic.com.
Disclosure: Salvà reports no relevant financial disclosures.
Perspective
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Magda Rau, MD
When we perform lensectomy and implant a multifocal IOL, the artificial lens provides near and intermediate vision, but the IPCL allows us to maintain the support of the intact natural lens.
In patients between 40 and 50 years, I am a little concerned about performing clear lens exchange. It is a safe procedure but not without risks and complications. A reversible, less invasive procedure is a welcome new option. Opti-K (NTK) did not fulfill my expectation, and I believe now that IPCL could be the answer.
There is a need for further studies to confirm efficacy and to answer the question of safety as far as the induction of cataract and glaucoma is concerned. There is also a need to find a reproducible method for calculating lens power in relation to the remaining accommodation of the crystalline lens.
Perspective
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Pavel Stodulka, MD, PhD
There is a new surgical option for presbyopia available with the IPCL, a presbyopic phakic IOL. This is a breakthrough in phakic IOL technology.
I implanted the world’s first presbyopic IPCL more than a year ago. At the beginning, we intended to implant this lens for emmetropic presbyopia. We consider this indication too risky, and today we implant it in presbyopic myopes, which seems to be an excellent indication.
We are following our patients, and 1-year results look fine and very encouraging.
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