Long-term Study of Artisan Phakic Intraocular Lens Implantation for the Correction of Moderate to High Myopia: Ten-Year Follow-up Results

Presented at: Congress of the American Society for Cataract and Refractive Surgery, April 2005, Washington, DC.

Received 4 January 2006; accepted 15 September 2006. published online 01 February 2007.

Purpose

To determine the long-term performance of the Artisan phakic intraocular lens (PIOL) for the correction of myopia.

Design

Long-term (10 years) retrospective follow-up study.

Participants

Eighty-nine eyes of 49 patients who underwent Artisan PIOL implantation for the correction of myopia.

Methods

Comparisons were made between preoperative clinical data and the clinical data at 1, 6, and 10 years after surgery.

Main Outcome Measures

Refractive stability, refractive predictability, safety, efficacy, best-corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), intraocular pressure, intraoperative problems, corneal endothelial cell density, corneal endothelial cell loss, and glare levels were evaluated.

Results

The mean spherical equivalent (SE) after 10 years was −0.70±1.00 diopters (D; range, −4.00 to 2.00 D), with no significant change in mean SE between 1, 6, and 10 years. At 10 years, 68.8% of all eyes were within 1.0 D of the intended correction. At 10 years, 31.2% (n = 24) gained 1 or more Snellen lines of BCVA and 2.6% (n = 2) lost more than 2 Snellen lines of BCVA; 93.3% reached a BCVA of 20/40 or better, and 82.0% reached a UCVA of 20/40 or better. The mean intraocular pressure remained stable and was 15.5±3.5 mmHg (range, 7–25 mmHg) at 10 years. The mean endothelial cell loss was −8.86±16.01% (range, −51.69% to 34.43%) at 10 years.

Conclusions

Long-term results demonstrate that the implantation of an Artisan PIOL for the correction of moderate to high myopia is a stable, predictable, and safe method when strict inclusion criteria for surgery are applied. There was no significant loss of corneal endothelial cells and no reports of long-term glare.

1 Department of Ophthalmology, Academic Hospital Maastricht, Maastricht, The Netherlands.

2 Sint-Truiden, Belgium.

Correspondence to Nayyirih G. Tahzib, MD, Department of Ophthalmology, Academic Hospital Maastricht, P. Debyelaan 25, 6202 AZ, Maastricht, The Netherlands.

Manuscript no. 2006-28.

Dr Budo is a medical monitor and consultant to Ophtec BV. No other author has a financial or proprietary interest in the products mentioned in the article.

PII: S0161-6420(06)01361-3

doi:10.1016/j.ophtha.2006.09.029

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