Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial.

Purpose: To evaluate the postoperative rotational stability of two prototype intraocular lens (IOL) designs (subsequently termed version 1 and version 2).

Patients And Methods: A prospective, multicenter, randomized, paired-eye, 6-month study evaluated the version 1 and version 2 IOLs. Results were compared with a control IOL (TECNIS toric 1-piece monofocal IOL) evaluated in a separate, similarly designed study.

Evaluation of the small-aperture intracorneal inlay: Three-year results from the cohort of the U.S. Food and Drug Administration clinical trial.

Purpose: To evaluate the safety and effectiveness of the Kamra small-aperture intracorneal inlay.

Setting: Centers in North America, Europe, Asia, and Australia.

Design: Prospective clinical trial.

Using an International Medical Advisory Board to guide clinical governance in a corporate refractive surgery model.

Purpose: To describe the role played by the International Medical Advisory Board (IMAB) in clinical and corporate governance at Optical Express, a corporate provider of refractive surgery.

Methods: A review of goals, objectives, and actions of the IMAB.

Results: The IMAB has contributed to study design, data analysis, and selection of instruments and procedures.

Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia.

Purpose: To compare the results of laser-assisted in situ keratomileusis (LASIK) and implantable collamer lenses (ICL) in the correction of myopia -4 to -7.88 D.

Methods: A total of 1678 LASIK eyes from the Davis Duehr Eye Center, Madison, WI, and 144 ICL eyes from the 14-site US FDA Clinical Trial for ICL for Myopia were compared.

Image quality in myopic eyes corrected with laser in situ keratomileusis and phakic intraocular lens.

Purpose: To compare image quality due to higher-order aberrations following laser in situ keratomileusis (LASIK) or implantation of phakic intraocular lens (PIOL) to correct high myopia.

Methods: Postoperative wavefront examinations, normalized to a pupil size of 5.5 mm, were obtained for 19 LASIK and 20 PIOL eyes for the same surgeon over the same time period.

Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia.

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

Methods: Five hundred fifty-nine LASIK eyes from the Davis Duehr Eye Center, Madison, WI, and 210 ICL eyes from the 14-site U.S.

Early spatial changes in the posterior corneal surface after laser in situ keratomileusis.

Purpose: To evaluate the forward shift of the posterior corneal surface after myopic laser in situ keratomileusis (LASIK) relative to the residual stromal bed thickness and the ablation percentage of the total corneal thickness.

Setting: Department of Ophthalmology, Ilsan Paik Hospital, Inje University, Ilsan, Korea.

Methods: Three hundred sixty-three eyes of 182 consecutive patients who had LASIK were examined retrospectively.

U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia.

Purpose: To assess the safety and efficacy of the Implantable Contact Lens (ICL) to treat moderate to high myopia.

Design: Prospective nonrandomized clinical trial.

Participants: Five hundred twenty-three eyes of 291 patients with between 3 and 20.

Incidence of lens opacities and clinically significant cataracts with the implantable contact lens: comparison of two lens designs.

Purpose: To compare the incidence of anterior subcapsular lens opacities, clinically significant cataracts, secondary lens-related surgical reinterventions, and vaulting characteristics of the now discontinued V3 and currently used V4 Staar Surgical Implantable Contact Lens (ICL) phakic intraocular lens designs.

Methods: In this non-randomized prospective clinical trial, 87 eyes were implanted with the V3 and 523 eyes with the V4 ICL as part of the U.S.