Mainz, Germany—The first clinical results from the European Multicenter Trial of the Artiflex foldable iris-claw phakic IOL (Ophtec, Groningen, the Netherlands) indicated that the implant is safe and effective for treating myopia after a 6-month follow-up period.
The Artiflex foldable phakic IOL is a 3-piece lens with a silicone body and polymethylmethacrylate (PMMA) haptics; the IOL has a total diameter of 8.5 mm, 6.0-mm optics, and a concave/convex optic with powers ranging from -2 to -12 D, Burkhardt Dick, MD, described.
"When implanting the foldable iris-claw IOL, surgeons will notice a clear difference between it and the regular Artisan/Verisyse IOL (Ophtec/AMO) in several ways," he said.
"A variation in implantation is that the Artiflex phakic lens is implanted with a device into which the IOL is inserted and the first haptic is then pressed down. The second is also fixated because the lens folds itself when implanted through the incision port. Because of the hydrophobic material, it is important not to have inflammatory cells attached to the IOL," Dr. Dick said. He is clinical assistant professor, Department of Ophthalmology, Johannes Gutenberg University of Mainz, Germany.
Once in the eye the lens is pushed back with a second instrument to facilitate its release into the anterior chamber. The implantation device is removed and the lens is then rotated. In contrast to implantation of the rigid PMMA lens, the enclavation is different. Because one haptic is fixed and the inferior haptic is free during implantation, the enclavation is done slightly superiorly to avoid lens displacement. Only the inferior haptic is used for enclavation, Dr. Dick explained.
Dr. Dick reported the results from 21 eyes with the Artiflex IOL implanted.
"The refractive stability was excellent over the 6-month follow-up. There were no lines of visual acuity lost. Seventy-seven percent of eyes had a gain of visual acuity, as is expected with myopia treated with phakic lenses.
"The efficacy was also high. All eyes had 20/30 or better uncorrected visual acuity. The efficacy index (the mean postoperative uncorrected visual acuity divided by the best-corrected preoperative visual acuity) was more than 100%. Predictability was high. There were no IOP increases. What was especially gratifying was that 2 hours after surgery the patients were able to see 20/20 uncorrected or at least their best preoperative corrected visual acuity. This was very rapid visual rehabilitation, which differs from implantation of the Artisan IOL," Dr. Dick reported.
In addition, there was no or very low induced astigmatism. Patient satisfaction with this IOL was extremely high, and all said they would choose the same implant again.
"There was no increase in IOP, no increase in inflammation, with the exception of two cases with an inflammatory response on the silicone optic. This was treated with intense, short-term prednisolone acetate and did not recur. There were no sight-threatening complications and there was no need for additional surgical interventions.
"From 6 months of follow-up, the IOL appears to be safe, stable, effective, and predictable for treating myopia. This is a clear improvement over PMMA phakic IOLs. I recommend that the companies change to foldable lenses rapidly," Dr. Dick said.
He also noted that because these are short-term results, longer studies with more eyes must be carried out before any definitive conclusions about the lens can be reached.