Investigational IOL demonstrates true accommodation

April 20, 2018

Findings from a pilot study show that a novel accommodative intraocular lens (AIOL, Lumina, Akkolens) provides a true accommodative response that is maintained for at least 2 years and preserved following Nd:YAG laser capsulotomy.

By Cheryl Guttman Krader; Reviewed by Jorge L. Alió, MD, PhD

Findings from a pilot study show that a novel accommodative intraocular lens (AIOL, Lumina, Akkolens) provides a true accommodative response that is maintained for at least 2 years and preserved following Nd:YAG laser capsulotomy.

Figure 1: The Akkolens Lumina Accommodative IOL (Figures courtesy of Jorge L. Alio, MD)

The study measured objective and subjective accommodative responses in 59 eyes of 43 cataract surgery patients implanted with the Lumina AIOL. The results were compared with those of 2 control groups comprised of 59 eyes of 43 cataract surgery patients implanted with a monofocal IOL (AcrySof SA60AT, Alcon Laboratories) and 25 healthy eyes of patients aged <30 years. The cataract surgery patients ranged in age from 43 to 85 years.

There was inter-individual variability within the Lumina AIOL group in both subjective and objective accommodation gain. However, the overall differences in both the objective and subjective measures of accommodation between the Lumina AIOL and monofocal IOL control groups were statistically significant.

In addition, the data collected suggested that at least two-thirds of the optical power change observed in the Lumina AIOL eyes was explained by real accommodation, whereas pseudoaccommodation contributed less than 30% to the outcome, reported Jorge L. Alió, MD, PhD, professor and chairman of ophthalmology, University Miguel Hernandez de Elche; medical director of the investigational study, VISSUM Instituto Oftalmologico de Alicante, Alicante, Spain.

“The results of this study show that the Lumina AIOL restores visual function after cataract surgery and improves near vision by changing the optical power of the eye,” said Dr. Alió.

 

 

Varifocal lens system

The Lumina AIOL is a dual-element, varifocal lens system that changes its focal power when ciliary muscle contraction and relaxation causes the optical elements to shift across each other in the plane perpendicular to the optical axis. The Lumina AIOL is not preloaded but inserted using a special injector through a 2.8 mm corneal incision into the ciliary sulcus.

“The lens is placed in the ciliary sulcus rather than in the capsular bag so that the only force exerted on the lens comes from the ciliary muscle and not from capsular bag shrinkage,” Dr. Alió said.

“When the eye accommodates and the ciliary muscle contracts, the sulcus-to-sulcus distance decreases and the optical elements change position, resulting in an increase in dioptric power and focusing of light for the near distance,” he added.

Outcomes in the study included distance near visual acuity defocus curves to determine subjective accommodation and objective accommodation measured with an open field autorefractor (WAM-5500, Grand Seiko). The tests in the cataract surgery patients were performed at 12 months postoperatively.

 

 

Significant differences

The defocus curves showed the expected pattern in the young control eyes, with the median defocus decimal visual acuity remaining above 0.8 across the range from -6.0 D through +0.5 D. There was a statistically significant difference comparing the defocus curves of the monofocal IOL control eyes and the Lumina AIOL group.

Figure 2: Data on the change of spherical equivalent from the distance to near measurement.

In the monofocal IOL group, median defocus visual acuity was above 0.8 only from -0.5 D to +0.5 D. Eyes implanted with the Lumina AIOL showed a median defocus above 0.8 VA from -2.5 D to +0.5 D.

The objective accommodative measurements showed no change in median refractive power in the monofocal control group as the stimulus changed from -2 D to -3 D, but a significant change in refractive power of the eye in the Lumina AIOL group. In the Lumina AIOL group, median refraction was -0.38 D for the -2.0 D stimulus, -0.73 D for the -2.5 D stimulus, and -0.73 D for the -3.0 D stimulus.

“Our finding that eyes implanted with the Lumina AIOL had a significantly higher change in refractive power than the monofocal controls for the accommodative stimuli of -2.D, -2.50 D, and -3 D, but less than the change observed in the young unoperated control group indicates that the refractive change measured in the Lumina AIOL eyes was associated with true accommodation,” Dr. Alió explained.

Subjective and objective accommodation were measured at 24 months in 14 eyes in the monofocal group and 17 Lumina AIOL eyes. The data showed the accommodative performance of the Lumina IOL over the monofocal IOL controls was the same as at 12 months.

Jorge L. Alió, MD, PhD

e. jlalio@vissum.com

This article is based on a presentation that was presented at the 2017 American Academy of Ophthalmology meeting. Dr. Alió has published a paper on objective and subjective accommodation of the Lumina AIOL [Alió JL, et al. J Refract Surg. 2018;34(2):78-83.]. Dr. Alió is a consultant to and receives clinical research grants from Akkolens.