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To compare the results of laser assisted in situ keratomileusis (LASIK) and implantable contact lenses (ICL) in the correction of moderate/high myopia.

 

Five hundred fifty-nine LASIK eyes from the Davis Duehr Eye Center, Madison, WI, and 210 ICL eyes from the 14-site U.S. FDA Clinical Trial for ICL for Myopia were compared. These series were concurrently operated on with 8 to 12 D of preoperative myopia and were examined at 1 day, 1 week, 1 month, 6 months, and 1 year postoperatively. The mean baseline myopia was slightly higher in the ICL group, (ICL: -9.8 ± 1.7 D; LASIK: -9.1 ± 0.97 D). BSCVA, UCVA, and refractions were collected prospectively in both series.

 

Every index of BSCVA, UCVA, predictability of refraction, and stability of refraction studied favored the ICL over the LASIK procedure. All but one of the indices (UCVA % 20/40 or better) were statistically significant in at least half of the time periods studied. At 6-month follow-up, both the loss of two or more lines (ICL: 0%; LASIK: 2%;p = 0.05) and gain of two or more lines (ICL: 7%; LASIK: 3%;p = 0.04) of BSCVA were better with the ICL. Similarly, efficacy outcomes with the ICL were better with predictability (attempted versus achieved ±1.0 D) of the ICL at 90%; 76% with LASIK (p < 0.001). In this highly myopic series, UCVA 20/20 or better was 50% with ICL compared with 35% with LASIK (p < 0.001). No serious complications occurred in either series of cases.

 

The ICL was safer and more effective than LASIK and appears to be a viable alternative to corneal refractive excimer surgery in the treatment of moderate to high myopia. The available options for the surgical correction of moderate to high myopia (≥8 D) are somewhat limited. While clear lens extraction is certainly a possibility, rates of retinal detachment following the procedure have been reported as high as 8%. 1 While LASIK procedures using commercially available excimer lasers have been approved in the United States for up to 14 D of myopia, the results have generally been worse in cases with 7 D and above than for lower amounts of myopia. 2-7 Phakic IOLs are currently in U.S. FDA clinical trials and may offer another alternative for these highly myopic patients. The implantable contact lens (ICL), a posterior chamber phakic IOL (STAAR Surgical, Monrovia, CA) has been in U.S. FDA clinical trials since 1996 and may be the first phakic IOL to be considered for commercial use. The purpose of this paper is to present a comparison of clinical outcomes with the current V4 version of the myopic ICL with current LASIK clinical outcomes for the correction of moderate to high myopic refractive errors.

 

Cornea: May 2003 - Volume 22 - Issue 4 - pp 324-331
Sanders, Donald R. M.D., Ph.D.; Vukich, John A. M.D.

 

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