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Artisan iris-claw phakic IOL appears safe, effective and predictable
Phase 2 study targets moderate and high myopia.
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---The Artisan iris-claw phakic IOL appears to be safe, effective and predictable for use in the treatment of moderate and high myopia.
MINNEAPOLIS — The Artisan (Ophtec USA, Boca Raton, Fla.) iris-claw phakic IOL appears to be safe, effective and predictable for use in the treatment of moderate and high myopia, according to Food and Drug Administration phase 2 study results.
“Patients are extremely happy. The Artisan provides early recovery and a stable refraction,” said Y. Ralph Chu, MD, a partner and attending surgeon at Minnesota Eye Consultants here. “It seems to be an excellent option for treating high degrees of myopia.”
---Biomicroscopy shows the position of Artisan lens in eye.
The study protocol covered myopia from 5 D to 20 D, along with adequate anterior chamber size, normal depth and less than 2.5 D of astigmatism. “There are now 193 eyes with a mean IOL power distribution of 13.16,” Dr. Chu related. However, the 22 eyes in the Minneapolis center “have a slightly higher skew. We basically reserve this IOL for patients who seem to be out of range for the laser procedures.”
---Artisan myopia lens by Ophtec implanted in eye.
Pupillary size is a concern with any type of phakic IOL. “Currently, we have a 6 mm and 5.5 mm optic available,” Dr. Chu said. “But the 6 mm is the preferred optic for the myopic lens.” In addition, preoperative intraocular pressure in patients was “essentially normal and it actually stayed normal through postoperative follow-up.”
To insert the Artisan lens, a peripheral iridectomy or iridotomy is required. “Most patients are receiving a 5.5 mm to 6 mm incision, either a clear corneal or limbal incision,” said Dr. Chu, who presented study results at the International Society of Refractive Surgery Symposium in Miami.
Study results
---Artisan lens implant with 5.5 mm optic implant in eye.
Sharing a visual graph of 90 eyes that correlated postop best corrected visual acuity (BCVA) with preop BCVA at 6 months, Dr. Chu explained that 100% of these patients achieved 20/40 or better at 6 months. “There’s sort of a skewing toward improved best corrective vision after surgery,” he said. Furthermore, 13% of the patients gained two or more lines of BCVA.
In a comparison of uncorrected postop visual acuity to the best corrected preop visual acuity at 6 months, “there are some trends to indicate that a patient’s uncorrected vision after surgery is very close to his best corrected vision preop,” Dr. Chu said. A select number of patients were targeted for monovision, however.
---Artisan lens implant with 6 mm optic implanted in eye.
Refractive predictability also is encouraging in all groups, with 62% of patients within ±0.5 D and 86% within ±1 D at 6 months. Furthermore, at 6 months to 1 year, there was about a 1.2% endothelial cell count loss, in contrast to only about 0.27% from preop to 6 months. However, the cell loss increased to 3.12% at 2 years. “Endothelial cell loss appears to eventually stabilize in the longer-term European studies,” Dr. Chu said.
Regarding complications, “cell and flare, corneal edema, mild glare and halos that seem to decrease with time were really the only persistent concerns at 6 months. But all the inflammation and edema seemed to be related to the trauma of the initial surgery,” Dr. Chu said. In addition, one lens was exchanged because of operating room error and another lens was exchanged due to halos.
---Artisan lens with 6 mm optic.
“These are basically all learning curve events. They seem to decrease as you gain more experience with implantation,” Dr. Chu said. He noted that long-term studies are needed, though, to assess the long-term safety of the lens. In the meantime, he and his colleagues continue nomogram refinement.
Phase 3 studies began in April, with 22 centers and 550 patients to be en rolled. “We hope to complete the phase later this year,” Dr. Chu said.
For Your Information:
- Y. Ralph Chu, MD, can be reached at Minnesota Eye Consultants, 1965 11th Ave. E, Ste. 102, Maplewood, MN; (651) 748-4405; fax: (651) 748-4409; e-mail: yrchu1@worldnet.att.net. Dr. Chu did not disclose whether he has a direct financial interest in any of the products mentioned in this article, or if he is a paid consultant for any companies mentioned.
- For more information on the Artisan iris-claw phakic IOL, contact Ophtec USA Inc., 6421 Congress Ave., Ste. 112, Boca Raton, FL 33487; (561) 989-8767; fax: (561) 989-9744.