Original articleCorrection of Moderate to High Myopia with a Foldable, Angle-Supported Phakic Intraocular Lens: Results from a 5-Year Open-Label Trial
Section snippets
Study Design
This pooled analysis included long-term data collected from 3 open-label clinical trials conducted in the United States (clinicaltrials.gov identifier, NCT00726024), the European Union (clinicaltrials.gov identifier, NCT00727805), and Canada (clinicaltrials.gov identifier, NCT00726297) from July 2002 through July 2012. The study design, patient recruitment, surgical techniques, and safety and efficacy assessment techniques of these studies have been described previously.8, 9 The study complied
Results
Results are presented to conform to the standard format for reporting refractive surgical data.10, 11 Interim 1- and 3-year data have been reported previously.8, 9
Discussion
Implantation of the AcrySof Cachet angle-supported pIOL improved UDVA and exceeded expected rates for predictability of refraction in patients with moderate to high myopia for up to 5 years. Lens acceptability was high, with 96% of patients (first eye) and 97% of patients (second eye) at year 5 reporting that they would undergo implantation of the same pIOL again.
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2018, American Journal of OphthalmologyCitation Excerpt :Two recent studies reported the 5-year results with these pIOLs in a nonrandomized setting, and showed a mean total EC loss of 8.9% and 13.7% from preoperatively to 5 years postoperatively that was similar to—or only slightly higher than—the results with the iris-fixated pIOLs described in the current paper.42,43 The 2016 article described the results of 1087 eyes and reported a decrease in ECD > 30% in 8.0% and an ECD ≤ 1500 cells/mm2 in 2.7% of eyes.43 Both studies emphasized the importance of sufficient distance between both central and peripheral pIOL and endothelium, but no study assessed the effect of these distances on EC loss.42,43
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Financial Disclosure(s): The author(s) have made the following disclosure(s): T.K.: Financial support − Abbott Medical Optics, Inc. (Santa Ana, CA); Alcon Laboratories, Inc. (Fort Worth, TX); Hoya Surgical Optics GmbH (Frankfurt, Germany); Rayner Surgical GmbH (Bamberg, Germany); Geuder AG (Heidelberg, Germany); Oculus Optikgerate GmbH (Wetzlar, Germany); Schwind Eye-Tech Solutions (Kleinostheim, Germany); Carl Zeiss Meditec AG (Jena, Germany); TearLab Corp. (San Diego, CA); Thieme Compliance GmbH (Erlangen, Germany); Zeimer Ophthalmology GmbH (Emmendingen, Germany); Editorship or board membership fees − Journal of Cataract and Refractive Surgery
W.A.M.: Financial support − Alcon Laboratories Inc. (Fort Worth, TX)
S.H.: Financial support − Alcon Laboratories Inc. (Fort Worth, TX); Clarion Medical Technologies (Cambridge, Ontario, Canada); Allergan Inc. (Irvine, CA); Patent − Method and apparatus for reducing outbreaks of diffuse lamellar keratitis (with Dr. D. W. Morck).
Supported by Alcon Research, Ltd., Fort Worth, Texas. The study sponsor participated in study design and data management, analysis, and interpretation, and reviewed and approved the manuscript.
Author Contributions:
Conception and design: Kohnen, Maxwell
Analysis and interpretation: Kohnen, Maxwell, Holland
Data collection: Kohnen, Maxwell, Holland
Obtained funding: none
Overall responsibility: Kohnen, Maxwell, Holland