Elsevier

Ophthalmology

Volume 123, Issue 5, May 2016, Pages 1027-1035
Ophthalmology

Original article
Correction of Moderate to High Myopia with a Foldable, Angle-Supported Phakic Intraocular Lens: Results from a 5-Year Open-Label Trial

Presented in part at: American Society of Cataract and Refractive Surgery/American Society of Ophthalmic Administrators Symposium and Congress, April 2014, Boston, Massachusetts; American Academy of Ophthalmology Annual Meeting, October 2014, Chicago, Illinois.
https://doi.org/10.1016/j.ophtha.2015.12.028Get rights and content

Purpose

To evaluate the 5-year efficacy of a foldable, hydrophobic, angle-supported phakic intraocular lens (pIOL) when used to correct moderate to high myopia.

Design

Prospective, nonrandomized, multicenter, open-label cohort study conducted in the United States, the European Union, and Canada (3 separate protocols).

Participants

This was a pooled analysis of 515 eyes from 360 patients 18 to 49 years of age with moderate to high myopia (preoperative corrected distance visual acuity [CDVA] ≤0.34 logarithm of the minimum angle of resolution [logMAR]) and with variance in the manifest refraction spherical equivalent within ±0.5 diopter (D) for a minimum of 12 months.

Intervention

Implantation of the AcrySof Cachet angle-supported anterior chamber pIOL (Alcon Laboratories, Inc., Fort Worth, TX).

Main Outcome Measures

Uncorrected distance visual acuity (UDVA), CDVA, predictability and stability of manifest refraction spherical equivalent (MRSE), serious adverse events, endothelial cell density, and patient satisfaction.

Results

Of 360 patients who received implantation in at least 1 eye (515 eyes), 326 (90.6%) completed the study (5-year best-corrected visual acuity data available for 415 eyes). At 5 years, a decrease in CDVA of 2 lines or more was observed in 0.5% of eyes (n = 2/415) compared with preoperative baseline. At 5 years, all 415 eyes achieved a CDVA of 0.34 logMAR or less; 91.3% (n = 379/415) had a CDVA of 0.04 logMAR or less. Mean UDVA ± standard deviation (SD) was 0.01±0.18 logMAR; 94.7% (n = 393/415) and 66.3% (n = 275/415) of eyes had a UDVA of 0.34 logMAR or less or 0.04 logMAR or less, respectively, at 5 years. Mean MRSE ± SD was −0.34±0.57 D (range,−2.50 to 1.63 D). Most eyes (89.8%; n = 371/413) had an MRSE within ±1.00 D of their target refractive error at 5 years and 67.3% (n = 278/413) were within ±0.50 D. Mean annualized central endothelial cell loss was 1.46% (90% confidence interval [CI], −1.6% to −1.3%) from 6 months to 5 years. The most common pIOL-related serious adverse event was adhesion between the cornea and the iris (synechia; n = 24). Most patients (98.1%) indicated that they would have the same pIOL implanted again.

Conclusions

In patients with moderate to high myopia, the AcrySof Cachet angle-supported pIOL provided excellent refractive correction for up to 5 years after implantation, with a low rate of mean central endothelial cell loss. Careful patient selection is necessary to achieve optimal postsurgical outcomes.

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.

References (23)

Cited by (26)

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  • Five-Year Endothelial Cell Loss After Implantation With Artiflex Myopia and Artiflex Toric Phakic Intraocular Lenses

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    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

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