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Implantable Contact Lens Improves Visual Acuity in Patients With Extreme Myopia: Presented at AAO

By Deanna M Green, PhD

ANAHEIM, CA -- November 21, 2003 -- The STAAR implantable contact lens (ICL) effectively improves visual acuity (VA) by reversibly adjusting corneal curvature in highly myopic patients, according to findings presented here November 17^th at the American Academy of Ophthalmology's 2003 Annual Meeting. Most complications reported can be reduced with better positioning and placement.

Phakic intraocular lenses (IOLs) are potential new alternatives to laser-based refractive surgery. One advantage of IOLs over laser surgery is that they can be removed if necessary. They also offer a therapeutic option to patients who are not eligible for laser surgery.

I. Howard Fine, MD, from Oregon Health & Science University, Portland, United States, presented three-year results from the US FDA Myopia ICL study, which evaluated the safety and efficacy of the STAAR ICL in moderately to highly myopic patients.

The prospective study included 369 myopic eyes between -3.0D and -20.0D. The STAAR ICL was implanted into the posterior chamber of each eye. VA, manifest refractive spherical equivalence (MRSE), and complications were assessed up to 36 months after implantation.

Overall, a ±1D MRSE was achieved in 88% of patients, and a ±0.5D MRSE was achieved in 68% of patients. Dr. Fine pointed out that this "is better than the FDA requirements for IOL and refractive surgery lasers."

Furthermore, 41% of patients had a 20/20 uncorrected distance VA or better at three years when all patients were considered, and 60% were 20/25 or better. Improvement of one line best-corrected VA was noted in 38%, and a two-line improvement was seen in 6%.

Importantly, Dr, Fine noted that "not all patients are candidates for such improvement." When only patients with a preoperative best-corrected VA of 20/20 that were targeted for emmetropia were considered, 95% had an uncorrected VA of 20/40 or better, and 59% had 20/20 or better at three years.

Sixty percent of patients had an uncorrected VA at three years that was the same as or better than their pre-operative best-corrected VA. Overall, 77% of patients were satisfied with their quality of vision at three years, and 99% were satisfied with the procedure.

Most complications were due to implant design or positioning difficulties, and 16 secondary ICLs were necessary. Cataracts were clinically significant and required extraction in three eyes (0.6%). Furthermore, a two-line loss of best-corrected VA occurred due to two retinal detachments, two cases of cataracts, and three cases of nuclear lens opacity.

"This study established the effectiveness and overall safety of myopia ICL in patients with moderate to high myopia," Dr. Fine concluded.


[Study title: 3-Year Results of the USFDA Myopia ICL Study. Abstract PA057]

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