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ReStor lens improved near vision without compromising distance in European study

Objective visual results with the IOL are “clearly excellent,” a commentator said.

Issue: February 15, 2005

ByKim Norton

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The Alcon AcrySof ReStor IOL provided good near visual acuity without compromising distance vision, according to 1-year results in a multicenter European clinical study.

Alcon calls the ReStor IOL an apodized diffractive pseudoaccommodative lens. Thomas Kohnen, MD, presented the results of an open label, non-randomized, non-controlled study of the lens at the American Academy of Ophthalmology meeting.

“Development of this lens should provide a broad functional vision range and enhance near vision, maintain distance vision and minimize visual disturbances,” Dr. Kohnen said.

The Alcon ReStor MA60D3 pseudoaccommodative apodized diffractive IOL is a three-piece IOL made from the familiar AcrySof material with modified-C PMMA haptics at 10° angulation. The IOL incorporates a +4 D add power at the IOL plane, equaling +3.2 D at the spectacle plane, according to company information.

The apodized diffractive optic is designed to allow a broad range of functional vision independent of pupil size and to minimize photic phenomena, Dr. Kohnen said.

One year, 6 months

His presentation was based on 1-year follow-up of 127 first-eye implants and 6-month follow-up of 119 second-eye implants at eight centers in Europe. He and colleagues evaluated distance visual acuity, near visual acuity, visual symptoms, patient satisfaction and spectacle independence. The study included patients at least 21 years old with bilateral cataract and 1 D of astigmatism or less.

In the first eye at 1 year, 85% of patients demonstrated uncorrected distance visual acuity of 20/40 or better. In the second eye at 6 months, 94.1% achieved 20/40 or better uncorrected, and binocularly at 6 months 99.2% of patients achieved 20/40 or better.

With best correction in place, 97.5% of first eyes saw 20/40 or better at 1 year, and with both the second eye and binocularly, 100% of patients achieved 20/40 or better vision at 6 months, Dr. Kohnen said.

Regarding near vision with distance correction in place, in the first eye at 1 year follow-up, 90% of subjects saw 20/40 at near, he said. In the second eye, 91.5% saw 20/40 at near, and binocularly 98.3% saw 20/40 at near at 6 months after the second surgery.

“Mean uncorrected logMAR near visual acuity results indicate that monocularly tested subjects achieved 20/30, while binocularly tested subjects achieved 20/25,” Dr. Kohnen said.

In contrast sensitivity testing at 25% contrast, 94% of the patients saw 20/40 or better in the implanted eye at 6 months after the first implantation. At 9% contrast, 59% saw 20/40 at the same evaluation, Dr. Kohnen said.

At 6 months following the second surgery, 96% of eyes saw 20/40 at 25% contrast, and at 9% contrast 69% saw 20/40 or better, he said.

Visual disturbances

The visual disturbances reported by the patients after the 6-month follow-up included blur, decreased night vision, halos and glare/flare. On a scale of 0 to 7, based on 118 patients reporting, the mean score for blur at near and far was 0.47 and 0.4 respectively. Night vision had a mean score of 0.62, and halos and glare/flare were reported with mild to moderate disturbance, Dr. Kohnen said.

None of these visual symptoms had a mean score greater than “mild” in severity, he said.

Two IOLs were explanted. In one case, due to power problems the lens was exchanged, and the second explant was removed due to glare problems, Dr. Kohnen said.

Patient satisfaction

Ninety-two percent of the patients in the study group said they would like to be implanted with the same lens again at 1 month after the first surgery, and after the second surgery this sentiment increased to 95.7%, Dr. Kohnen said.

Regarding spectacle independence, at 6 months after the second surgery 88% of patients said they did not wear glasses for distance vision, and 84.6% said they did not wear glasses for near vision, Dr. Kohnen said. Twelve percent said that “sometimes” they used glasses for near vision.

“The patients’ quality of life in regard to spectacle independence improved for near and distance vision; more than 95% of the subjects reported satisfaction with this lens,” Dr. Kohnen said.

Discussion

Richard L. Lindstrom, MD, who was the discussant of Dr. Kohnen’s paper at the AAO, agreed that objective visual outcomes are “clearly excellent” with the AcrySof ReStor MA60D3, but he noted that subjective outcomes were “good but not excellent” and that unwanted visual phenomena were reported with the lens.

Ten percent of patients implanted with the IOL had significant night vision dysfunction, similar to previous reports with the Advanced Medical Optics Array multifocal IOL, Dr. Lindstrom said, “so with night vision symptoms we have not improved significantly.” And 4.3% may have been unhappy enough not to want the lens implanted in the second eye, he said.

“The ReStor is clearly a promising IOL; the optical design is attractive and logical,” Dr. Lindstrom said. With the apodized design, the patient gets better near visual acuity with a small pupil and better distance acuity with a large pupil, he said.

Because the technology behind multifocal and accommodative lenses is evolving, more research and data accumulation are necessary, Dr. Lindstrom said.

“As they improve, accommodative IOLs remain an attractive option,” Dr. Lindstrom said.

For Your Information:

• Thomas Kohnen, MD, can be reached at the University of Frankfurt, Department of Ophthalmology, Theodor-Stern Kai 7, Frankfurt 60590 Germany; 49-69-62-01-67-39; fax: 49-69-63-01-38-93. Richard L. Lindstrom, MD, Chief Medical Editor of Ocular Surgery News, can be reached at Minnesota Eye Consultants, 710 E. 24th St., Suite 106; Minneapolis, MN 55404; 612-813-3600; fax: 612-813-3660; e-mail: rllindstrom@mneye.com.
• Alcon, manufacturer of the AcrySof ReStor MA60D3 IOL, can be reached at 6201 South Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-568-6142; Web site: www.alconlabs.com/.

• Kim Norton is an OSN Staff Writer who covers all aspects of ophthalmology.