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Refractive Surgery Technology



Refractive surgery technologies include studies in the areas of excimer lasers, holmium lasers, enhancement surgeries, incisional surgeries, corneal inlays, phakic intraocular lenses for moderate-to-high myopia and hyperopia, therapeutic applications of existing technologies, relationship between subjective and objective data, wavefront analysis and technology development.


Verisyse™/ARTISAN? Phakic Intraocular Lens (PIOL) for Nearsightedness
Studies in Follow-up Stages

Minnesota Eye Consultants, P.A. was one of 22 clinical sites selected in the United States to participate in a study of the Verisyse™ (formerly ARTISAN?) phakic intraocular lens for nearsightedness. While study enrollment is closed, follow-up visits are still being completed.

The ARTISAN™ lens is an intraocular lens indicated for the correction of nearsightedness and farsightedness. They are designed to be permanently implanted into the eye to reduce or eliminate dependency on glasses or contact lenses.

Device and Procedure Description
The Verisyse™ (formerly ARTISAN?) phakic intraocular lens is produced by OPHTEC BV and distributed in the United States by AMO. The lens is indicated to reduce or eliminate the need for glasses or contact lenses in nearsighted moderate to high nearsighted individuals. These individuals may not qualify for laser vision correction because they have a high refractive correction, thin corneas, or a preference for non-laser vision correction. In contrast to a laser procedure, where tissue is permanently removed, the Verisyse™ lens can be removed, if needed. The Verisyse™ lens is comprised of a convex or concave, 5- or 6-mm optic, on an 8.5-mm wide elliptical carrier 22. To implant the lens, the surgeon first creates an opening in the iris with a laser to assist fluid flow through the chambers of the eye. With the eye under topical or local anesthetic, the surgeon creates incisions in the eye, inserts the lens using specialized instruments, and fixes the lens to the outer edges of the iris . Following implantation, the ARTISAN™ lens rests on the edge of the iris, vaulted over the central iris and pupil, and positioned in front of the natural lens of the eye.

Study Summary

Minnesota Eye Consultants, P.A. participated in a clinical study of the Verisyse™ (formerly Artisan?) lens for the treatment of nearsightedness. Patients were at least 21 years of age, had nearsightedness ranging from -5.0 to -20. diopters, with up to 2.5 diopters of astigmatism. Minnesota Eye Consultants served as one of 22 clinical sites across the country and enrolled almost 170 eyes under the direction of its investigators. The data collected from this study was included in OPHTEC's submission for FDA approval of the Verisyse™ lens.

Recent Information

The FDA recently approved the Verisyse™ (Artisan?) phakic intraocular lens for use in the United States for the treatment of nearsightedness. This is the first phakic IOL to receive FDA approval in the United States. Surgeons now have the option of treating patients with nearsightedness ranging from -5.0 to -20.0 diopters using this lens.


Study History- Refractive Surgery

A clinical evaluation of the Zyoptix XP Microkeratome for use in LASIK surgery

Prospective evaluation of differences in patient assessments of nighttime visual aberrations following Laser In-Situ Keratomileusis (LASIK) with an 8.00mm transition zone

LASIK using the Technolas 217A excimer laser for the correction of naturally occurring farsightedness (hyperopia) between 1.0-4.0 D of spherical refraction with up to 2.0 D of refractive astigmatism

A prospective multicenter clinical trial to evaluate the safety and effectiveness of the Refractive Corneal Shaping (RCS) system for the correction of farsightedness (hyperopia) utilizing the Conductive Keratoplasty (CK) procedure

Study to determine the outcomes of laser vision correction following treatment with the VISX STAR S2 excimer laser system

The effect of brimonidine tartrate 0.5% in preventing optic nerve damage caused by elevated intraocular pressure during Laser In-Situ Keratomileusis (LASIK)

LASIK using the Technolas 217A excimer laser for the correction of 1.0-12.0 D of nearsightedness (myopia) with 0.5-5.0 D of astigmatism

LASIK using the Technolas Keracor 116 excimer laser for the correction of 1.0-15.0 D of nearsightedness (myopia) with up to 7.0 D of astigmatism

Laser Thermal Keratoplasty (LTK) using the holmium laser system - fellow eye protocol

Laser Thermal Keratoplasty (LTK) using the holmium laser system for the correction of farsightedness (hyperopia)

Extended intrastromal corneal ring segments (Intacs) for the correction of nearsightedness (myopia)

Taunton 200/2015 excimer laser therapy for moderate nearsightedness (myopia)

Photoastigmatic Refractive Keratectomy for myopic astigmatism

Chiron Technolas Keracor 116 excimer laser for the retreatment of eyes with undercorrected refractive error following Photorefractive Keratectomy (PRK)

Randomized, multicenter clinical trial to compare surgical correction of nearsightedness (myopia) with excimer laser Photorefractive Keratectomy (PRK) versus Laser In-Situ Keratomileusis (LASIK)

Prospective evaluation of Laser In-Situ Keratomileusis (LASIK) for the enhancement of previous surgery in patients with hyperopic refractive error

Topical steroid use versus no steroid use following Laser In-Situ Keratomileusis (LASIK) surgery for low amounts of nearsightedness (myopia)

Prospective evaluation of bilateral and sequential unilateral Laser In-Situ Keratomileusis (LASIK)

Prospective evaluation of bilateral and sequential unilateral Laser In-Situ Keratomileusis (LASIK) with arcuate keratotomy

Prospective evaluation of bilateral and sequential unilateral Laser In-Situ Keratomileusis (LASIK) for the enhancement of previous corneal surgery

Mini Radial Keratotomy (RK)

Technolas Keracor 16 laser for the correction of residual myopia

Analgesic efficacy of ketorolac non-preserved ophthalmic solution in subjects undergoing Radial Keratotomy (RK)

Randomized, comparative clinical trial to evaluate a small diameter corneal inlay for the correction of monofocal vision associated with presbyopia

Randomized, comparative clinical trial to evaluate a small diameter corneal inlay for the correction of monofocal vision in pseudophakic patients

Taunton 200/2015 excimer laser therapy for mild to moderate myopia

Astigmatism Reduction Clinical Trial (ARC-T) using AK

Excimer laser therapy for the reduction of specific cases of myopia and hyperopia [subset] Photorefractive Keratectomy (PRK) high myopia Phase II-B

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