Crystalens 3-year data show movement, near vision are maintained

NEW ORLEANS — Even after 3 years in the eye, an accommodative IOL still demonstrated movement upon pharmacological manipulation, according to one study. A separate study of the same lens found good near and distance vision and high patient satisfaction 3 years after implantation.

Steven J. Dell, MD, discussed his study of movement of the eyeonics Crystalens accommodative IOL here at the refractive surgery subspecialty day at the American Academy of Ophthalmology meeting. He said the degree of movement observed using immersion ultrasound was consistent with the near visual acuity demonstrated by the patients in the study.

Dr. Dell said he had observed that patients with the Crystalens were demonstrating near visual acuity about as good at 3 years postop as they had at 1 year, “and the question we had was, ‘Is the IOL still moving?’”

The study was performed in 10 eyes at least 3 years after Crystalens implantation. All patients had “excellent distance vision,” Dr. Dell said, with a mean uncorrected distance acuity slightly better than 20/20. Their distance-corrected near visual acuity was also good, with a mean of J 2.1, he said.

Immersion ultrasound was performed in each eye under the influence of cyclopentolate and under the influence of pilocarpine to determine the maximum range of movement of the IOL, Dr. Dell said.

He found that the lenses moved anteriorly a mean of 0.84 mm under cyclopentolate compared to their position under pilocarpine.

Taking into account the IOL powers implanted, this movement would correspond to a mean accommodative change of 1.79 D, Dr. Dell said, which he said was consistent with patients’ near visual performance with distance correction in place.

At a separate presentation, George I. Papastergiou, MD, said patients implanted with the Crystalens had excellent distance and near visual acuity without glasses at 36-month follow-up.

“Patients who received Crystalens were very satisfied even 36 months after the operation,” he said.

Dr. Papastergiou and colleagues measured near and distance visual acuity with and without correction, as well as accommodative range, in 84 pseudophakic eyes at least 3 years after the Crystalens was implanted.

All eyes achieved uncorrected distance visual acuity of 20/40 or better, and 93% had uncorrected near acuity of J 3 or better, Dr. Papastergiou said. The pseudoaccommodative amplitude ranged from 0.75 D to 2 D, he added.

Dr. Papastergiou cautioned that the lens should not be implanted in eyes with pupils larger than 6 mm and that the long-term incidence of fibrosis still must be studied.

These results were similar to those attained in the study submitted for Food and Drug Administration approval of the Crystalens, according to I. Howard Fine, MD, the discussant of Dr. Papastergiou’s presentation. Dr. Fine, who participated in the FDA study, said one aspect of the Crystalens that has always troubled him is that investigators have never been able to consistently demonstrate the lens’ exact mechanism of action in the eye. Despite this, he said, the data have conclusively shown that “the lens works,” and furthermore it has scored well among patients who were asked pointed questions about their quality of life following surgery.