Lens Implants May Improve Post-Cataract Surgery Focus

NEW ORLEANS — A foldable, pseudoaccommodative intraocular lens being tested in Europe shows promise of freeing most users from the need to wear glasses after removal of their cataracts, Thomas Kohnen, M.D., said at the annual meeting of the American Academy of Ophthalmology.

The apodized diffractive lens, known as the AcrySof ReSTOR IOL model MA60D3, was designed to provide a broad functional range, said Dr. Kohnen of Johann Wolfgang Goethe University in Frankfurt, Germany. The lens has 12 diffractive zones, favoring near vision when the pupils contract and distance vision when they expand. “Subtle zone transition provided minimization of visual disturbances and pupil-independent vision,” he said in a presentation of preliminary data.

Eight surgeons are participating in the ongoing open-label trial, which has enrolled 127 patients in France, Germany, Italy, and the United Kingdom. Eligibility requirements included healthy eyes except for bilateral cataracts and 1 D of astigmatism. The trial design does not include a control group.

Dr. Kohnen's presentation focused on 118 patients who had the lens implanted in both eyes. All had been followed for 1 year after the first lens was placed in one eye and 6 months after placement of a second lens in the other eye.

The lens appeared to maintain distance vision while enhancing near vision. Only one patient did not achieve uncorrected distance vision of 20/40 or better with binocular use, and 84% of patients reached 20/25 or better. Uncorrected near vision was at least 20/40 for 98% after 6 months of binocular use, and two-thirds of patients achieved 20/25 without reading glasses.

Visual symptoms fell into the mild to moderate range on a scale of 1–5. The most severe was glare/flare, which registered 1.92. It was followed by halos (1.28), night vision (0.62), blurred near vision (0.47), and blurred far vision (0.4).

Seventy-four percent of 118 patients said they never wore glasses 6 months after the lens was implanted in both their eyes. Distance vision was strong enough for 88% to do without glasses for seeing far objects. Near vision was almost as good, with 84.6% able to give up their reading glasses.

Manufacturer Alcon Inc. of Fort Worth, Tex., is seeking U.S. Food and Drug Administration approval for the ReSTOR IOL, which has been approved in Europe. Dr. Kohnen noted that 100% of patients in the study achieved best-corrected distance vision of 20/40 or better at 6 months after bilateral implantation—exceeding an FDA goal of 92.5%.

Richard Lindstrom, M.D., in private practice in Minneapolis, reviewed the presentation, calling the objective outcomes excellent and the subjective outcomes good. He noted, though, that 10.4% had “significant unwanted vision problems” and two patients had to have the lens removed. Despite concerns about night vision, he concluded that the ReSTOR lens is promising.

NEW ORLEANS — A foldable, pseudoaccommodative intraocular lens being tested in Europe shows promise of freeing most users from the need to wear glasses after removal of their cataracts, Thomas Kohnen, M.D., said at the annual meeting of the American Academy of Ophthalmology.

The apodized diffractive lens, known as the AcrySof ReSTOR IOL model MA60D3, was designed to provide a broad functional range, said Dr. Kohnen of Johann Wolfgang Goethe University in Frankfurt, Germany. The lens has 12 diffractive zones, favoring near vision when the pupils contract and distance vision when they expand. “Subtle zone transition provided minimization of visual disturbances and pupil-independent vision,” he said in a presentation of preliminary data.

Eight surgeons are participating in the ongoing open-label trial, which has enrolled 127 patients in France, Germany, Italy, and the United Kingdom. Eligibility requirements included healthy eyes except for bilateral cataracts and 1 D of astigmatism. The trial design does not include a control group.

Dr. Kohnen's presentation focused on 118 patients who had the lens implanted in both eyes. All had been followed for 1 year after the first lens was placed in one eye and 6 months after placement of a second lens in the other eye.

The lens appeared to maintain distance vision while enhancing near vision. Only one patient did not achieve uncorrected distance vision of 20/40 or better with binocular use, and 84% of patients reached 20/25 or better. Uncorrected near vision was at least 20/40 for 98% after 6 months of binocular use, and two-thirds of patients achieved 20/25 without reading glasses.

Visual symptoms fell into the mild to moderate range on a scale of 1–5. The most severe was glare/flare, which registered 1.92. It was followed by halos (1.28), night vision (0.62), blurred near vision (0.47), and blurred far vision (0.4).

Seventy-four percent of 118 patients said they never wore glasses 6 months after the lens was implanted in both their eyes. Distance vision was strong enough for 88% to do without glasses for seeing far objects. Near vision was almost as good, with 84.6% able to give up their reading glasses.

Manufacturer Alcon Inc. of Fort Worth, Tex., is seeking U.S. Food and Drug Administration approval for the ReSTOR IOL, which has been approved in Europe. Dr. Kohnen noted that 100% of patients in the study achieved best-corrected distance vision of 20/40 or better at 6 months after bilateral implantation—exceeding an FDA goal of 92.5%.

Richard Lindstrom, M.D., in private practice in Minneapolis, reviewed the presentation, calling the objective outcomes excellent and the subjective outcomes good. He noted, though, that 10.4% had “significant unwanted vision problems” and two patients had to have the lens removed. Despite concerns about night vision, he concluded that the ReSTOR lens is promising.

NEW ORLEANS — A foldable, pseudoaccommodative intraocular lens being tested in Europe shows promise of freeing most users from the need to wear glasses after removal of their cataracts, Thomas Kohnen, M.D., said at the annual meeting of the American Academy of Ophthalmology.

The apodized diffractive lens, known as the AcrySof ReSTOR IOL model MA60D3, was designed to provide a broad functional range, said Dr. Kohnen of Johann Wolfgang Goethe University in Frankfurt, Germany. The lens has 12 diffractive zones, favoring near vision when the pupils contract and distance vision when they expand. “Subtle zone transition provided minimization of visual disturbances and pupil-independent vision,” he said in a presentation of preliminary data.

Eight surgeons are participating in the ongoing open-label trial, which has enrolled 127 patients in France, Germany, Italy, and the United Kingdom. Eligibility requirements included healthy eyes except for bilateral cataracts and 1 D of astigmatism. The trial design does not include a control group.

Dr. Kohnen's presentation focused on 118 patients who had the lens implanted in both eyes. All had been followed for 1 year after the first lens was placed in one eye and 6 months after placement of a second lens in the other eye.

The lens appeared to maintain distance vision while enhancing near vision. Only one patient did not achieve uncorrected distance vision of 20/40 or better with binocular use, and 84% of patients reached 20/25 or better. Uncorrected near vision was at least 20/40 for 98% after 6 months of binocular use, and two-thirds of patients achieved 20/25 without reading glasses.

Visual symptoms fell into the mild to moderate range on a scale of 1–5. The most severe was glare/flare, which registered 1.92. It was followed by halos (1.28), night vision (0.62), blurred near vision (0.47), and blurred far vision (0.4).

Seventy-four percent of 118 patients said they never wore glasses 6 months after the lens was implanted in both their eyes. Distance vision was strong enough for 88% to do without glasses for seeing far objects. Near vision was almost as good, with 84.6% able to give up their reading glasses.

Manufacturer Alcon Inc. of Fort Worth, Tex., is seeking U.S. Food and Drug Administration approval for the ReSTOR IOL, which has been approved in Europe. Dr. Kohnen noted that 100% of patients in the study achieved best-corrected distance vision of 20/40 or better at 6 months after bilateral implantation—exceeding an FDA goal of 92.5%.

Richard Lindstrom, M.D., in private practice in Minneapolis, reviewed the presentation, calling the objective outcomes excellent and the subjective outcomes good. He noted, though, that 10.4% had “significant unwanted vision problems” and two patients had to have the lens removed. Despite concerns about night vision, he concluded that the ReSTOR lens is promising.