Wavefront-guided PRK treatment of myopia using a refractive aberrometer.

PURPOSE: To evaluate the safety, effectiveness, and patient-reported outcomes of wavefront-guided photorefractive keratectomy (PRK) for the correction of myopic refractive errors with and without astigmatism. SETTING: U.S. multicenter study. DESIGN: Prospective, nonrandomized clinical investigation. METHODS: 334 eyes (167 patients) underwent wavefront-guided PRK with the STAR S4 IR Excimer Laser System. Patients had preoperative myopic refractive errors with sphere up to -8.00 diopters (D) and cylinder up to -4.00 D with a maximum spherical equivalent (SE) of -10.00 D. All eyes were targeted for emmetropia, and treatment plans were derived from the iDESIGN system wavefront measurements. RESULTS: At 6 months, the point of refractive stability, 99.4% of eyes achieved 20/20 or better uncorrected distance visual acuity (UDVA), 92% of eyes achieved 20/16 or better UDVA, 85.5% of eyes achieved manifest refraction SE (MRSE) within 0.50 D of target, mean SE was -0.06, and less than 1% of eyes lost more than 2 lines of corrected distance visual acuity. Glare and halos occurred with similar or lower frequencies at 6 months vs preoperative. Results from the National Eye Institute Refractive Error Quality of life questionnaire showed statistically significant improvements at 6 months vs preoperative across most measures of vision-related functioning and well-being. Approximately 98% of patients reported high satisfaction with their overall vision at 6 months. CONCLUSIONS: Wavefront-guided PRK with the iDESIGN aberrometer was safe, effective, and predictable for the correction of low to moderate myopia with and without astigmatism and led to high patient satisfaction.

Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial.

PURPOSE: To compare the effectiveness and safety of the TECNIS Symfony intraocular lens (IOL; ZXR00) with the TECNIS 1-piece monofocal IOL (ZCB00). SETTING: 15 sites in the United States. DESIGN: Prospective, randomized, patient-masked/evaluator-masked clinical trial. METHODS: Randomized participants received either the ZXR00 or ZCB00 IOL bilaterally. The 6-month postoperative outcomes included monocular and binocular distance, intermediate, and near visual acuity (VA), spherical equivalent refraction and refractive cylinder, spectacle wear, and visual symptoms. RESULTS: Overall, 299 patients were implanted with a study IOL (ZXR00 IOL, n = 148; ZCB00 IOL control, n = 151). At the 6-month follow-up, mean binocular uncorrected distance VA was comparable between ZXR00 and ZCB00 IOL recipients (P = .1011). The ZXR00 IOL group had significantly better mean binocular uncorrected intermediate VA and uncorrected near VA (both P < .0001) than the ZCB00 IOL group. The mean binocular distance-corrected intermediate VA and distance-corrected near VA were also better in the ZXR00 IOL group (both P < .0001). More ZXR00 IOL recipients reported wearing spectacles none of the time or a little of the time for overall vision at 6 months compared with the ZCB00 IOL group (85.0% vs 59.9%, P < .0001). In the ZXR00 IOL-implanted patients, low incidence rates of night glare (mild to moderate, 2.7%), halo (mild to moderate, 13.6%; severe, 2.7%), and starbursts (mild to moderate, 7.5%; severe, 1.4%) were reported. CONCLUSIONS: The TECNIS Symfony IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased spectacle wear and low incidence rates of dysphotopsia, compared with the TECNIS 1-piece monofocal IOL.

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. Participants aged ≥22 years and scheduled to undergo bilateral cataract extraction were randomly assigned 1:1 to receive the version 1 or version 2 IOL in the first operative eye; the alternate test IOL was then implanted in the second operative eye. RESULTS: Mean absolute IOL rotation at postoperative week 1 was the primary effectiveness end point. Additional end points included the percentage of eyes with postoperative IOL rotation >5°/>10°, direction of lens rotation, surgeon-reported ease of IOL handling during implantation, and safety. At postoperative week 1, mean (±standard deviation) absolute IOL rotation was significantly lower for both version 1 and version 2 versus control (0.88° [±0.94] and 0.71° [±0.69] vs 2.24° [±3.21], respectively; both P < 0.001). For both study lenses, absolute rotation was <5° for all eyes at postoperative week 1, and no cases of rotation >10° were observed at any postoperative time point. From postoperative week 1 onward, version 2 had a statistically significant clockwise bias in the direction of rotation (P = 0.03); similar findings were observed for version 1. Surgeons reported acceptable ease of IOL handling during implantation for both version 1 and version 2. No device-related adverse events were reported. CONCLUSION: Both the version 1 and version 2 IOLs, each with frosted, squared haptics, demonstrated improved postoperative rotational stability compared with a control lens without frosted haptics. Because version 2 had the same overall geometry as the current TECNIS toric IOL, this design was selected for commercialization. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015287.