Damian McNamara

May 11, 2016

NEW ORLEANS — A new extended-range-of-vision intraocular lens fared well in terms of visual acuity in a prospective, bilateral, randomized, patient- and investigator-masked trial conducted at 15 sites in the United States.

For distance visual acuities, uncorrected and best corrected, monocular and binocular, "this lens performs very similar to a monofocal; there was no difference statistically between the two," said Jason Jones, MD, from the Jones Eye Clinic in Sioux City, Iowa.

"This lens really delivers excellent distance acuity, definitely enhanced intermediate vision, and improved near focus," he told Medscape Medical News.

Dr Jones presented the study results during a packed session here at the American Society of Cataract and Refractive Surgery 2016 Symposium.

He and his colleagues randomized 148 people to an extended-range-of-vision intraocular lens (Tecnis Symfony, Abbott Medical Optics) and 151 to a monofocal intraocular lens (Tecnis, Abbott Medical Optics).

The researchers compared visual acuity, defocus curves, spectacle wearing, and patient satisfaction. Follow-up was 6 months.

Table. Monocular Visual Acuity With the Two Intraocular Lenses

Vision Outcome Extended Lens (logMAR) Monofocal Lens (logMAR)
Uncorrected intermediate 0.087 0.256
Distance-corrected intermediate 0.104 0.342
Distance-corrected near 0.323 0.544

 

In terms of intermediate vision, one of the primary end points, "we see an improved function in favor of the Symfony lens," Dr Jones reported. Overall, the monocular visual acuities measured in the study significantly favored the extended lens (P < .0001).

For patients with monocular intermediate uncorrected vision at 66 cm, 20/25 vision was achieved by about three-quarters of the people who received the extended lens and by about one-third of those who received the monofocal lens. "So it's quite good," Dr Jones said.

"In the distance-uncorrected vision, we do see a little bit of drop, but not much," he noted. More patients in the extended group than in the monofocal group achieved 20/25 vision or better (70.0% vs 13.5%).

Near Vision

"Monocular uncorrected near vision at 40 cm is still performing quite well," said Dr Jones. Again, more patients in the extended group than in the monofocal group achieved 20/40 vision or better (80% vs 30%).

"The distance-corrected near vision acuities show a little bit of a shift here, but near vision is still quite good," he explained, at 60% in the extended group and 16% in the monofocal group.

 
You get one to two lines of extra visual acuity performance with Symfony.
 

With the extended lens, visual performance in patients with uncorrected or distance-corrected monocular and binocular vision showed good improvement. A defocus curve subassessment showed 20/32 vision out to a range of –1.5 D, "and you get one to two lines of extra visual acuity performance with Symfony out to about –4 diopters of defocus as well," Dr Jones said.

In this study, "patients had a high rate of spectacle independence," he noted. A majority, 85%, said they "wear spectacles 'none or a little of the time,' which is quite high." Again, the results favored the extended over the monofocal lens.

Session panelist William Culbertson IV, MD, from the University of Miami, asked about the subjective evaluation of symptoms like glare. Dr Jones deferred to a colleague in the audience who presented results on that issue during a separate session at the meeting.

In clinical trials in the United States, "severe glare issue was 0%, so pretty impressive there. It was 1.4% for severe starbursts and 2.8% for halos," said James Loden, MD, from Loden Vision Centers in Goodlettsville, Tennessee. This is "much, much lower than what we've seen in the traditional monofocal studies."

"Safety was equal between the two groups. They performed well with no significant issues," Dr Jones explained.

The extended lens features an elongated focus from echelettes on the posterior surface, and refractive rings and enhanced chromatic aberration control for improved contrast sensitivity.

The Symfony intraocular lenses is currently under marketing review by the US Food and Drug Administration (FDA).

"The biggest concerns with multifocal intraocular lenses have always been the chromatic aberrations and the potential for night-time dysphotopsia. With these low-add lenses, the blur circle is smaller," said Dee Stephenson, MD, a private practice eye surgeon in Venice, Florida, who is president of the American College of Eye Surgeons.

"While the halos and glare are still there, they are much less bothersome, and the Symfony design goes even a step further toward eliminating night-vision problems," she told Medscape Medical News.

The echelette design features rings with increasing foci that provide a continuous curve rather than two distinct focal-point peaks. "This is a much more natural visual experience," said Dr Stephenson. "The design is also forgiving with regard to residual refractive error. This is a nice addition to the current armamentarium of intraocular lens platforms."

"This is an exciting technology that adds to our options for decreasing spectacle independence for our patients," said session panelist Audrey Talley Rostov, MD, from Northwest Eye Surgeons in Seattle.

"Once it is FDA-approved and available on the American market, it will be interesting to see how it compares with existing-technology intraocular lenses and fits into clinical practice," she added.

Dr Jones is a paid investigator for Abbott Medical Optics. Dr Culbertson and Dr Loden are consultants for Abbott. Dr Stephenson and Dr Talley Rostov have disclosed no relevant financial relationships.

American Society of Cataract and Refractive Surgery (ASCRS) 2016 Symposium. Presented May 8, 2016.

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