Elsevier

Ophthalmology

Volume 109, Issue 5, May 2002, Pages 955-964
Ophthalmology

Article for CME Credit
Comparison of iris-fixed Artisan lens implantation with excimer laser in situ keratomileusis in correcting myopia between −9.00 and −19.50 diopters: A randomized study

https://doi.org/10.1016/S0161-6420(02)00964-8Get rights and content

Abstract

Objective

To compare Artisan lens implantation with laser in situ keratomileusis (LASIK) for the correction of myopia between −9.00 and −19.50 diopters.

Design

Prospective randomized clinical trial.

Participants

Ninety eyes of 61 consecutive patients were enrolled in the study.

Intervention

Forty-five eyes (50%) received Artisan lens, and 45 eyes (50%) received LASIK; the procedure assigned to each eye was randomized. Eighteen patients (29.5%) received Artisan lens in one eye and LASIK in the other.

Main outcome measures

Slit-lamp microscopy, manifest refraction, uncorrected and spectacle-corrected visual acuity, contrast sensitivity, and specular microscopy were performed before surgery, and 1, 3, 6, and 12 months after surgery. Patient satisfaction and preference were assessed by a subjective questionnaire.

Results

At 1 year, 43 eyes (95.6%) from the Artisan group and 41 eyes (91.1%) from the LASIK group were examined, the mean spherical equivalent refraction was −0.64 ± 0.8 diopter in the Artisan eyes and −0.87 ± 0.8 in the LASIK eyes. The uncorrected visual acuity was 20/20 or better in 9 Artisan eyes (20.9%) and 5 LASIK eyes (12.2%) and 20/40 or better in 38 Artisan eyes (88.4%) and 24 LASIK eyes (58.5%); no Artisan eyes and 5 LASIK eyes (12.2%) lost 2 or more Snellen lines of spectacle-corrected visual acuity. One Artisan eye (2.3%) and six LASIK eyes (14.6%) reported severe night glare; the Artisan lens was exchanged with a larger optic diameter lens. Mean endothelial cell loss at 1 year was 0.7 ± 1.1 cells/mm2 in the Artisan eyes and 0.3 ± 0.9 cells/mm2 in the LASIK eyes. Contrast sensitivity curve decreased by 2 or more lines in two Artisan (4.7%) and six LASIK eyes (14.6%). Of the 18 patients who received both surgeries, one in each eye, 13 patients (72.2%) preferred the Artisan procedure because of the better quality of vision.

Conclusions

In this study, Artisan lens implantation and LASIK were found to be similarly effective, stable, and reasonably safe for the correction of myopia between −9.00 and −19.50 diopters. Better uncorrected and spectacle-corrected visual acuity and contrast sensitivity, a lower enhancement rate, and exchangeability are the main advantages of Artisan lens implantation. Thirteen (72.2%) of the 18 patients who received the Artisan lens in one eye and LASIK in the other preferred the Artisan lens to the LASIK, mainly because of the better quality of vision.

Section snippets

Study design and patient population

Between April and November 1998, 90 eyes of 61 consecutive patients were enrolled in a prospective, randomized study. Forty-five eyes received the Artisan lens (Ophtec BV, Groningen, The Netherlands) and 45 eyes received LASIK. The procedure assigned to each eye was randomized, using a random number table. Patients selected for the study met inclusion criteria, including age of at least 21 years, documented stable refraction for 1 year, spherical equivalent refraction between 9.00 and 19.50 D

Results

Of the 90 eyes included in this trial, 45 eyes (50%) had Artisan lens implantation (Artisan eyes) and 45 eyes (50%) had LASIK (LASIK eyes). Patients ranged in age from 21 to 47 years (mean, 33.7 ± 7.1 years). Of the 61 patients, 37 (60.7%) were female. Eighteen patients (29.5%) had Artisan lens in one eye and LASIK on the other (Artisan/LASIK subgroup), 5 patients (8.2%) had Artisan lens in both eyes, 6 patients (9.8%) had LASIK on both eyes, 17 patients (27.9%) had Artisan in one eye, and 15

Discussion

A high follow-up examination rate (mean, 94.0%) was achieved throughout the first year. This is explained by the enrollment of only those patients who said that they could follow the postoperative examination schedule given to them before surgery.

References (23)

  • T. Seiler et al.

    Iatrogenic keratectasia after laser in situ keratomileusis

    J Refract Surg

    (1998)
  • Cited by (106)

    • Phakic intraocular lens implantation for the correction of hyperopia

      2019, Journal of Cataract and Refractive Surgery
    • Iris-fixated phakic intraocular lens implantation to correct myopia and a predictive model of endothelial cell loss

      2015, Journal of Cataract and Refractive Surgery
      Citation Excerpt :

      In this study, we have reported the 5-year safety, efficacy, refractive predictability, and stability of the Artisan pIOL to correct high myopia, and have introduced a new linear model predicting endothelial cell loss after pIOLs implantation. Several clinical reports1,3,8–11,15–20 have demonstrated that stabilization of the postoperative refraction occurs within the first few years after surgery with a high safety index. The 5-year follow-up obtained in the present study showed comparable results on refractive stability; indeed, 5 years after Artisan pIOL implantation, the mean SE was −0.75 ± 0.74 D.

    View all citing articles on Scopus
    3

    None of the authors has any financial or proprietary interest in any materials or methods described within this article.

    View full text