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New sulcus-implanted IOL provides true accommodation in presbyopic eyes
Two free-form optics shift inside the eye to provide sharp vision at all distances.
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A novel sulcus-implanted lens may offer an alternative way to achieve true accommodation, providing 2 D to 5 D of near add power.
Made of a hydrophilic acrylic material, the Lumina IOL (Akkolens) is based on the principle of the Alvarez lens, in which two complementary refractive plates translated laterally produce a progressive change in optical power.
“Two sinusoidal optical surfaces slide across one another along the horizontal axis, following the Alvarez principle, thanks to the vectorial forces generated by the ciliary body during the accommodation process. The magnification and power of the lens changes in a continuous, progressive way, allowing the patient to focus at all distances,” Jorge L. Alió, MD, PhD, an OSN Europe Edition Board Member, said.
Jorge L. Alió
Former surgical experiences with the Lumina were in partially sighted eyes and performed mainly in Alicante, Spain, and Moscow, by Alió and Boris Malyugin, MD, PhD, respectively.
At the Resbiomed Eye Clinic in Sofia, Bulgaria, the lens has been implanted since December 2012 in 27 eyes of cataract patients with normal sight. Alió performed phacoemulsification and implanted the lens in the sulcus through a 2.8-mm incision using Akkolens’ proprietary single-use injector.
Evidence of accommodation was shown at 1 month and 3 months by subjective testing, near visual data analyzed by defocus curve and an objective assessment of accommodation using the WAM-5500 system (Grand Seiko).
“The Lumina shows in many patients a high-profile defocus curve plateau that can expand up to 3.5 D at 20/20 visual acuity. In other patients, it shows a slow decay of visual acuity at increasing accommodative stimulus. This slow decay greatly supports accommodation at lower visual acuities. Again, other eyes show a combination of a plateau and a slow decay of the visual acuity,” Alió said.
This flat, high area is similar to what is found in children’s eyes, he said. Overall visual outcomes achieved in eyes implanted with the Lumina are currently being analyzed and compared with the results obtained from control patients whose eyes were implanted with a standard AcrySof IQ monofocal lens (Alcon) under the same conditions and by the same surgeon.
“Defocus curves are substantially different. With the monofocal lens, the curve goes up steep and immediately comes down after achieving the peak of 20/20 vision, whereas the curve of the Lumina stays up at the high level for longer, showing the typical plateau pattern,” he said.
No twin peaks, typical of the bimodal distribution of light of multifocal IOLs, were seen.
“There is no sacrifice of intermediate acuity with the Lumina lens. Vision is sharp at all distances,” Alió said.
No unusual complications
Patients did not experience unusual complications or discomfort following surgery. In the early postoperative period, one eye developed posterior capsular opacification, which was treated with standard YAG laser. Vision and accommodation were rapidly restored.
“We have to expect slightly higher PCO rates with sulcus-based lenses compared to lenses implanted in the capsular bag. However, it is good to know that a standard YAG treatment can be applied with the Lumina,” Alió said.
An increased incidence of glare may also theoretically be expected because the Lumina has four optical surfaces, compared to the two surfaces of other lenses, he said. However, such incidence has not yet been reported.
The clinical trial will soon be expanded to additional centers in Slovenia and Spain. After determining the safety and efficacy of the lens in cataract patients, it is expected that clear lens exchange procedures in presbyopic eyes will follow.
“We are still in the early stages of the clinical trial, but this is the very first time that artificial accommodation has been demonstrated with a sulcus-based lens in sighted eyes,” Alió said.
The Lumina IOL is expected to obtain CE mark after the completion of these trials and to be launched on the market in about 1 year. – by Michela Cimberle
- For more information:
- Jorge L. Alió, MD, PhD, can be reached at Vissum Corporation, Avenida de Denia, s/n, 03016 Alicante, Spain; +34-965150025; fax: +34-965151501; email: jlalio@vissum.com.
Disclosure: Alió is a consultant to AkkoLens.