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Capsule contraction syndrome reported after accommodating IOL implantation
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SEATTLE — A small number of cases of capsule contraction syndrome has been reported after the first 25,000 implants of the eyeonics Crystalens, according to a speaker here.
In the clinical trial data on 500 eyes submitted to the Food and Drug Administration for premarket approval of the accommodative IOL, no incidence of capsule contraction syndrome was reported, said Harvey L. Carter, MD.
The Crystalens, designed to provide a continuous range of vision from distance through intermediate to near, has been approved for marketing in the United States since 2003 for patients undergoing cataract surgery and for correction of presbyopia.
Dr. Carter said he was the first surgeon to encounter a case of capsule contraction syndrome (CCS) following Crystalens implantation. He described the syndrome here at the ASCRS Summer Refractive Congress. Prior to this report of 57 cases in 25,000 implants, eyeonics said it had been made aware of 30 cases of CCS among the first 13,000 implants.
“So we are seeing roughly the same rate of incidence,” Dr. Carter said.
He said the onset of symptoms occurs between 1 and 7 months postoperatively and seems more common in patients less than 60 years old, but CCS has been seen “in virtually all age groups.” He noted that most of the patients in the FDA trial were older than 60 years and had cataract.
Dr. Carter said that although CCS also occurs with standard IOLs, before “the advent of the Crystalens technology it really didn’t matter that much.” Because the Crystalens technology allows the lens to move in the capsule, the occurrence of CCS can be significant.
Symptoms of CCS include an asymmetrical vault of the IOL that can be seen at the slit lamp, striae in the posterior capsule and an oval appearance of the capsulorrhexis over the plate of the Crystalens. Also, patients may report a gradual myopic shift, he said.
Dr. Carter described perioperative strategies to reduce the incidence of the syndrome. These include reducing the amount of retained cortex at the time of surgery by meticulous removal of cortex from underneath the Crystalens, avoiding creation of a capsulorrhexis of less than 4.5 mm, and educating patients to notify the surgeon if they perceive a gradual but sustained decrease in visual acuity.
“Early treatment is better than late treatment,” he said.
Although surgeons may be tempted to try to correct the syndrome surgically, this does not work, Dr. Carter said. The syndrome is best managed by application of YAG laser directly to areas of obvious retained cortex, he said.
According to Dr. Carter, the eyeonics scientific advisory board released the following recommendations for intraoperative and postoperative care: Create a capsulorrhexis of 5.5 mm to 6 mm, perform meticulous capsule clean-up, rotate the Crystalens at least 90° to free hidden cortex and ensure proper haptic location, and treat with an anti-inflammatory for a minimum of 4 weeks.
A full report of the diagnosis, treatment and prevention of CCS will appear in the September 15 issue of Ocular Surgery News U.S. Edition.