San Diego-The Artisan Hyperopia IOL (Ophtec BV) appears to be safe, effective, and stable for the treatment of high and extreme hyperopia, according to Edward E. Manche, MD, who reported the interim results of the FDA phase III clinical trial at the American Society of Cataract and Refractive Surgery annual meeting.
"The Artisan lens is indicated for axial hyperopia ranging from 3 to 12 D. Model 203, used in this trial, has a 5-mm optic, is 8.5 mm long, and is available in 1-D increments. In the eye, the IOL is enclavated in the midperipheral iris," Dr. Manche explained.
The trial of this IOL began in 1997. Based on the results achieved with this lens in patients with myopia, phase II was waived by the FDA. Phase III was designed to enroll 440 patients at 25 sites.
Dr. Manche reported the results from 73 lenses implanted in 47 subjects (55% female; average age, 40 years) at 13 sites. The type of incision created was based on surgeon preference, and there was an equal distribution among corneal, limbal, and scleral incisions.
The average correction was about +7.5 D. Most eyes had an anterior chamber depth between 3.2 and 3.4 mm; 19% of eyes had an anterior chamber depth ranging from 3.5 to 3.9 mm.
When the investigators analyzed the predictability of the procedure, 90% of the eyes were within 1 D of the intended correction and almost 50% were within 0.5 D of the intended correction 6 months after implantation. One year after implantation, the results were stable with 85% of eyes within 1 D of the intended correction and 56% within 0.5 D of the intended correction.
"As expected with an IOL procedure, the refraction was quite stable essentially from the first day after implantation because the integrity of the cornea is not compromised. There is no regression of effect after the first postoperative day," he said.
"The net change at 1 year after implantation was a loss of about 1.6%," he said.