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Phakic IOL shows long-term safety for the endothelium
The safety of the implant might be attributable to high adaptability of the lens to the eye.
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PARIS — The Alcon AcrySof Cachet phakic IOL continues to show promising outcomes in terms of endothelial safety, according to current reports.
 Béatrice Cochener |
“The long-term effects on the endothelium are of course the main concern with this angle-supported lens. Previous implants of the same kind, such as the GBR (IOLTech) and the Icare (Cornéal), were withdrawn from the market due to the sudden, dramatic cell loss occurring at about 3 years after implantation,” Béatrice Cochener, MD, said at the meeting of the French Society of Ophthalmology.
The progress of the AcrySof Cachet has been followed closely, with encouraging results thus far. The lens has been used for 5 to 8 years by some surgeons, who have reported no complications. Furthermore, official data about corneal endothelium safety at 3 years are available from a multicenter, prospective study in Europe, Canada and the U.S.
“They are comforting data. A combination of material and design has made this lens overcome the problems of previous models. It seems that we can now enjoy the advantages of angle-supported technology without worrying too much about complications,” Dr. Cochener said.
The safety of the implant is likely due to the high adaptability of the lens to the eye. The high refractive-index hydrophobic acrylic material allows for a thin, 6-mm optic construction. The haptics are supple and adapt to the angle without stretching it, she noted.
Multicenter study
The multicenter study involved a total of 360 patients: 190 in Europe, 120 in Canada and 50 in the U.S. Patients were implanted in one eye only and were between 18 and 49 years of age. Mean spherical equivalent was 10 D, anterior chamber depth including the cornea was at least 3.2 mm, and endothelial cell density in relation to age was normal for all patients.
Evaluation of corneal endothelium was carried out using a specular microscope. Images were acquired in five locations at the center and periphery of the cornea, three for each site, and sent to a specialized image analysis center for evaluation. Endothelial health assessment was repeated every 6 months.
“Changes in endothelial cell density were minimal over 3 years. Centrally, mean endothelial cell density changed from 2,957 cell/mm2 preop to 2,778 cell/mm2 at 3 years. In percentage, this is –0.4%. In the periphery, endothelial cell count decreased from 2,857 cell/mm2 to 2,706 cell/mm2, in percentage: –0.7%,” Dr. Cochener said.
Corneal endothelial cells are mainly hexagonal in shape. When cell loss or cell damage occurs, neighboring cells enlarge to fill in the space and often lose their hexagonal shape. Evaluation of cell morphology is therefore important to assess epithelial health.
“Cell morphology was maintained after surgery and over 3 years in the center and periphery. Only minimal changes in cell size were reported after surgery and only in the periphery,” Dr. Cochener said.
IOL implantation
Successful implantation of the AcrySof Cachet depends on well-controlled surgery. The lens is easy to implant with the Monarch III delivery system, which allows well-controlled implantation through a 2.8-mm incision.
“Upside-down implantation can be now avoided thanks to side-up indicators placed on the haptics,” Dr. Cochener noted.
The surgeon should try to minimize intraoperative manipulation and prevent the risk of IOP rise with the careful use of viscoelastic. Excessive irrigation and aspiration should also be avoided, and IOP should be measured 4 to 6 hours postoperatively.
In the study, the sizing of the lens was based on white-to-white measurement. No imaging system was used, and implantation was not made easier by orientation marks or by the Monarch III injector.
“In spite of this, no case of pupil ovalization was reported and no abnormal endothelial cell loss occurred also in case of lens rotation,” Dr. Cochener said.
“The study endpoint is at 5 years, but some patients, study phase 2, have already reached 8 years follow-up and did not show any complications. By then, we should be confident that the lens is completely safe for the endothelium,” she said. – by Michela Cimberle
- Béatrice Cochener, MD, can be reached at Institut de Synergie des Sciences de la Santé, CHU Morvan University of Brest, Bât 2 bis, 5 avenue Foch, 29609 Brest Cedex, France; +33-2-98-01-81-30; fax: +33-2-98-22-34-40; e-mail: beatrice.cochener-lamard@chu-brest.fr.