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Corneal injectable phakic IOL demonstrates good stability and visual outcome
The lens is a foldable, one-piece design with symmetric, four-point angle fixation and a large optic.
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BOLOGNA – The new ICARE phakic IOL by Corneal provides safe and effective correction of myopia and hyperopia, and has several advantages over other lenses, according to Alessandro Mularoni, MD, in practice here.
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“I am enthusiastic about it. Implantation is easy and nontraumatic, recovery is fast, and thanks to its particular design, the lens is very stable in the eye but doesn’t stretch the pupil,” said Dr. Mularoni.
The lens is an angle-fixation single piece and is available in four sizes, from 12 mm to 13.5 mm. It is available in a range of dioptric powers from –20 D to –5 D, in 0.25-D steps.
The material is hydrophilic acrylic with a 26% water content. It is a highly biocompatible, supple, foldable material, which allows implantation through a small (3- to 3.2-mm) incision and unfolds gently and smoothly inside the anterior chamber, according to Dr. Mularoni.
“The good news is that this is the first anterior chamber lens that can be implanted with an injector,” he said. Currently Dr. Mularoni uses a Corneal injector designed for other IOLs, but a specific instrument will soon be available, he said.
According to Dr. Mularoni, insertion through a small incision is important for preventing astigmatism. It is especially important in this kind of surgery, which is performed mainly on young patients, he said.
Design details
The lens interacts well with surrounding structures because of its particular design, Dr. Mularoni said.
The ICARE lens is symmetrical, with a large optic and four symmetrically positioned haptics of equal size. According to Dr. Mularoni, forces are equally distributed on the angle, which helps enhance lens centration and stability and also prevents pupil ovalization.
The 5.75-mm optic prevents halos and glare, Dr. Mularoni said. None of the patients implanted with this lens have complained of these phenomena, he added.
The IOL vaulting is calculated so that the surfaces maintain the maximum possible distance from both the anterior capsule and the endothelium.
“This lens has safer margins on both sides than any other type of lens, which prevents cell damage and cell proliferation,” he said.
The ICARE is scarcely noticeable once it is implanted in the eye, Dr. Mularoni said, which gives the lens an aesthetic advantage over other phakic IOLs.
“Given the high percentage of young people undergoing this surgery, this aspect is not to be underestimated,” Dr. Mularoni said.
Easy implant, improved outcomes
Implantation of the ICARE is simple, Dr. Mularoni said. Surgery is carried out under topical anesthesia. The lens is inserted in the cartridge with viscoelastic and injected through a 3- to 3.2-mm incision. Forceps can also be used, but “the advantages of injectors are undeniable,” he said.
According to Dr. Mularoni, the lens unfolds slowly and gently in the eye, ensuring maximum safety of the endothelium.
“After surgery you can see a very clear, stable eye, with no signs of inflammation,” he said.
The ICARE is presently undergoing a multicenter trial in Italy and Europe. Dr. Mularoni has implanted six of the ICARE lenses, the highest number in the trial so far. Four lenses were implanted bilaterally in two patients, and the remaining two were implanted in one eye of two other patients. Only myopic models were used, as the hyperopic lens will only be available until December 2002. Patients (two men and two women) had high myopia, ranging from –11 D to –17 D.
The follow-up of the first implant is now at 3 months.
“The lens has shown very good predictability of results. None of the patients have a residual refractive error of more than –1 D, and we have had no cases of IOP increase, no postop inflammatory reaction, no induced astigmatism and visual recovery was very fast. [Between] day 1 and 2, all patients had very good visual acuity,” Dr. Mularoni said.
For Your Information:
- Alessandro Mularoni, MD, can be reached at Ospedale Maggiore, Largo Negrisoli 2, 40133 Bologna, Italy; +(39) 051-6478608; fax: +(39) 051-6478945; e-mail: alessandro.mularoni@ausl.bologna.it.
- Corneal, manufacturer of the ICARE phakic IOL, can be reached at 31 Rue des Colonnes, 75012 Paris, France; +(33) 1-43-42-9393; fax: +(33) 1-43-07-0190; e-mail: export@corneal.com.