AcrySof Phakic Angle-supported Intraocular Lens for the Correction of Moderate-to-High Myopia: One-Year Results of a Multicenter European Study

Presented in part at: the American Academy of Ophthalmology annual meeting, November 2006, Las Vegas, Nevada.

Received 13 August 2008; received in revised form 27 January 2009; accepted 27 January 2009. published online 01 June 2009.

Purpose

To investigate the safety and effectiveness of the AcrySof phakic angle-supported intraocular lens (IOL) (Alcon Laboratories, Inc., Fort Worth, TX) for correction of moderate-to-high myopia in adults.

Design

One-year interim analysis of a phase 3, nonrandomized, open-label, prospective, multicenter European clinical study.

Participants

A total of 190 subjects (190 eyes) with moderate-to-high myopia. The preoperative mean manifest refraction spherical equivalent (MRSE) was −10.38 diopters (D) ±2.43 standard deviation (SD).

Methods

Unilateral implantation of the AcrySof phakic angle-supported IOL.

Main Outcome Measures

Best spectacle-corrected visual acuity (BSCVA), uncorrected distance visual acuity (UCVA), predictability and stability of MRSE, adverse events, and endothelial cell density.

Results

Of 190 subjects enrolled, 161 completed the 1-year postoperative visit. No subjects lost ≥2 lines BSCVA. A UCVA of 20/20 or better was achieved by 57.8%; 99.4% had 20/40 or better. A BSCVA of 20/32 or better was achieved by 100% of subjects; 85.7% had 20/20 or better. The mean MRSE was −0.23 D (±0.50 D: −2.50 to 0.75 D). Residual refractive error was within ±1.0 D from the target for 95.7% of subjects and within ±0.5 D for 72.7% of subjects. The overall mean percentage change in central endothelial cell density 1 year after surgery was −4.77±8.04% (n = 139). No pupil ovalization, pupillary block, or retinal detachment events were observed.

Conclusions

The AcrySof phakic angle-supported IOL yielded excellent refractive correction and predictability with acceptable safety in subjects with moderate-to-high myopia. These 1-year interim analysis findings demonstrate preliminary support for the safety and efficacy of this IOL.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Available online: May 30, 2009.

1 Johann Wolfgang Goethe-University, Department of Ophthalmology, Frankfurt/Main, Germany

2 FreeVis LASIK Center, University Eye Clinic Mannheim, Mannheim, Germany

3 CHU Morvan, Service Ophtalmologie, Brest, France

4 Eye clinic Ahaus, Ahaus, Germany

5 Hôpital Purpan, Service d'Ophtalmologie, Toulouse, France

6 Groupe Hospitalier Pellegrin, Service d'Ophtalmologie, Bordeaux, France

7 Instituto Oftalmologico de Alicante, Alicante, Spain

8 Unità Operativa di Oculistica, Verona, Italy

9 Hospital General Santo Antonio, Porto, Portugal

Correspondence: Thomas Kohnen, MD, Professor of Ophthalmology, Johann Wolfgang Goethe-University, Department of Ophthalmology, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany

Manuscript no. 2008-973.

The study group is available in Appendix 1 at http://aaojournal.org.

Financial Disclosure(s): The author(s) have made the following disclosure(s):

Michael C. Knorz is a paid consultant for Alcon Inc. and AMO Inc.

Thomas Kohnen is a paid consultant for Alcon Inc.

Jean L. Arné is a paid consultant for Alcon Inc.

Beatrice Cochener is a paid consultant for Alcon Inc., AMO Inc., Bausch & Lomb, and THEA.

Joseph Colin is a paid consultant for Alcon Inc.

Jorge L. Alió is a paid consultant for Alcon Inc.

Supported by Alcon Laboratories, Inc., Fort Worth, Texas, as a clinical investigational project.

PII: S0161-6420(09)00103-1

doi:10.1016/j.ophtha.2009.01.041

*Note: Add-ons open in a new browser window. Please disable any pop-up blocking software before viewing Add-ons.

15 of 41