July 08, 2009
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Angle-supported phakic IOL shows good refractive correction at 1 year

Ophthalmology. 2009;116(7):1314-1321.

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A 1-year interim analysis of an angle-supported phakic IOL found that the IOL yielded good refractive correction and predictability with acceptable safety in subjects with moderate-to-high myopia.

The open-label, prospective, multicenter phase 3 clinical study investigated the safety and efficacy of the AcrySof phakic angle-supported IOL (Alcon) for correcting moderate-to-high myopia among 190 eyes of 190 adult patients. At baseline, mean manifest refraction spherical equivalent for the cohort was –10.38 D.

Of the 161 patients who returned for 1-year postop analysis, no patients lost two or more lines of best corrected visual acuity.

An uncorrected visual acuity of 20/20 or better was achieved by 57.8% of patients, while 99.4% of patients achieved a UCVA of 20/40 or better.

All patients achieved a BCVA of 20/32 or better, while 85.7% had achieved a BCVA of 20/20 or better.

At 1 year, the mean manifest refraction spherical equivalent was –0.23 D.

In addition, the study found that the residual refractive error was within ±1 D from the target for 95.7% of patients and within ±0.5 D for 72.7% of patients. The mean change in central endothelial cell density was –4.77% among 139 patients at 1 year.

The investigators observed no pupil ovalization, pupillary block or retinal detachments.