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New Phakic ACL Shows Promise for Treatment of High Myopia
Dermot McGrath
in MUNICH
THE new AcrySof phakic anterior chamber lens (Alcon Laboratories) appears to offer a safe and effective option for the treatment of moderate to high myopia, according to Professor Joseph Colin, MD and other researchers who presented their findings here at the XXI Congress of the ESCRS. "I have been very impressed with its performance to date. The AcrySof lens is relatively straightforward to implant, gives a good refractive outcome and is very well tolerated," Dr Colin said. The single-piece ACL is a foldable, soft acrylic lens, made from hydrophobic polyacrylic elastomer, with a 5.5 mm biconvex meniscus optic that is designed for placement in the anterior chamber. It can correct refractive errors from -6.0 D to -16.5 D. Dr Colin said that 12 patients in Bordeaux had received the lens as part of a European multicentre clinical trial involving 102 patients in nine centres. The initial results, with 72 patients now at six-month's follow-up and Dr Colin's 12 patients approaching the two-year threshold, were very encouraging, he said. Of 72 patients who received the lenses for myopia, 49% gained one line of BCVA acuity, 17% gained two lines and 15.4% gained more than two lines at the six-month follow-up stage. None of the eyes lost any lines of BCVA. The postoperative uncorrected vision for patients with a pre-operative BCVA of 20/20 or better was similarly encouraging, noted Dr Colin. In those patients postoperative UCVA was 20/20 or better in 87%, 20/25 in 6.5%, and in a similar percentage it was 20/32.
"All of the patients have achieved outstanding results. No pupil ovalisation has been noted due to the special design of the lens, which minimises stress on the corneal endothelium. It has proven itself to be highly biocompatible while giving excellent refractive stability," he said. Postoperative assessment of safety included operative and postoperative complications, endothelial cell loss, change in crystalline lens status, and change in best corrected visual acuity versus baseline. Efficacy assessments, according to Dr Colin, included target versus achieved refraction, change in refraction over time and uncorrected visual acuity versus baseline. Information on IOL position, tilt and decentration was also collected. Dr Colin noted that because the lens is soft, one-piece and foldable, it can be injected through a small incision, thereby reducing the chances of surgically-induced astigmatism and limiting manipulations inside the eye. In another French study, Béatrice Cochener MD and colleagues at the University of Brest Hospital implanted the AcrySof lens unilaterally in 24 patients with moderate to high myopia ranging from –8.0 to –21.0 diopters.
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More than 80% of patients achieved the intended correction in uncorrected visual acuity and refraction. Best corrected
visual acuity was improved by one to three lines in 40% of patients. While changes in contrast and glare sensitivity were regularly observed, patient satisfaction remained high. The researchers reported no significant modification in endothelial density or gonioscopic findings.In a German study carried out by Stefanie Schmickler MD and colleagues at Ahaus Eye Clinic between October 2001 and October 2002, a total of 18 highly myopic subjects (range: -8.0 to -15.0 D) were unilaterally implanted with the AcrySof lens. The first day postoperative UCVA was 0.8 or better and postoperative follow-up at six months saw all patients reaching BCVA 1.0 or better and UCVA of 0.9 or better. Summing up the clinical data, Dr Colin said that while a longer follow-up was necessary to properly assess key safety issues, the lens seemed to effectively address the main problems previously associated with angle-supported anterior IOLs such as pupil ovalisation, endothelial cell loss, and glare.
"We now know that low compression forces are necessary to avoid pupil ovalisation and the design of the AcrySof phakic lens successfully addresses this problem. This factor in conjunction with the biocompatibility and ease of folding of the acrylic material has resulted in outstanding clinical results to date in my patients," he said.
Dr Joseph Colin MD
Hôpital Pellegrin-Tripode - Service d'ophtalmologie
Bourdeaux, France
joseph.colin@chu-bordeaux.fr
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