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.

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. METHODS: Patients with emmetropic presbyopia had intracorneal implantation of the inlay in the nondominant eye. RESULTS: The study comprised 507 patients with emmetropic presbyopia who were aged 45 to 60 years old. The implanted eyes exhibited 3.5 diopters of defocus range above 20/40, with 363 (87.1%) of 417 patients and 391 (93.8%) of 417 patients having 20/40 or better monocular and binocular uncorrected near visual acuity (UNVA) at 36 months, respectively. Patients implanted via a femtosecond laser pocket procedure using a spot/line setting of 6 µm × 6 µm demonstrated further improved near vision, with 131 (90.3%) of 145 patients and 137 (94.5%) of 145 of patients having 20/40 or better monocular and binocular UNVA, respectively. Uncorrected distance visual acuity 20/25 or better was maintained in 135 (93.1%) of 145 of implanted eyes and 100% (145) of 145 of implanted eyes binocularly at 36 months. Less than 1.5% of eyes had a loss of 2 or more lines of corrected distance visual acuity for 3 months or more at any time after surgery. Forty-four inlays (8.7%) were removed from the full cohort over 3 years. The removal rate was significantly less in the 6 × 6 pocket group (3.0% for visual complaints) and further reduced with deeper implantation (0%). Less than 1.0% of the patients reported severe glare or halos postoperatively. CONCLUSION: The small-aperture corneal inlay was found to be safe and effective, improving near vision both monocularly and binocularly with minimal effect on distance visual acuity.

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. Through interactions with Optical Express corporate and clinical staff, the IMAB has supported management's effort to craft a corporate culture focused on continuous improvement in the safety and visual outcomes of refractive surgery. CONCLUSIONS: The IMAB has fashioned significant changes in corporate policies and procedures and has had an impact on corporate culture at Optical Express.

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. Both series were concurrently operated on with 4 to 7.88 D of preoperative spherical equivalent of the manifest refraction and were examined at 1 day, 1 week, 1 month, and 6 months postoperatively. The mean baseline myopia was slightly higher in the ICL group (ICL: -6.4 +/- 1.1 D; LASIK: -5.6 +/- 1.1 D). Best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), and refractions were collected prospectively in both series. RESULTS: BSCVA loss of at least 2 lines was significantly higher in the LASIK series in the early healing period (1 week: 6% vs. 0.7%; P = 0.008), whereas a BSCVA gain of at least 2 lines was statistically better with the ICL at 1 (5% vs. 0.9%, P = 0.001) and 6 months (4% vs. 0.8%, P = 0.013). Proportion of cases seeing 20/15 or better uncorrected (21.6% vs. 7.8%, P < 0.001) and 20/20 or better (67% vs. 57%, P = 0.027) at 6 months postoperatively was better in the ICL group. The ICL was statistically more predictable (attempted vs. achieved) at 6 months; +/-0.50 D (79% ICL vs. 70% LASIK, P = 0.034) and +/-1.0 D (97% ICL vs. 88% LASIK, P < 0.001). Stability was achieved (95% < or = 1.0 D) at the 1-week to 1-month interval for both groups (95% LASIK; 98% ICL). The stability of refraction (< or =0.5 D change) was significantly better in the ICL group than the LASIK group through 6 months. No serious complications occurred in either series. CONCLUSIONS: The ICL was safer and more effective than LASIK and seems to be a viable alternative to corneal refractive excimer surgery in the treatment of low myopia.

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. Higher-order aberrations and simulated retinal images were compared. RESULTS: For this small sample, the LASIK eyes yielded an average three times more spherical aberration and two times more coma than PIOL eyes. The effects of these differences were visualized using the simulated retinal images. CONCLUSION: Spherical aberration and coma are the major differences between postoperative LASIK and PIOL higher-order aberrations, and simulated retinal images can be used to visualize these effects.

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. FDA Clinical Trial for ICL for Myopia were compared. These series were concurrently operated on with 8 to 12 D of preoperative myopia and were examined at 1 day, 1 week, 1 month, 6 months, and 1 year postoperatively. The mean baseline myopia was slightly higher in the ICL group, (ICL: -9.8 +/- 1.7 D; LASIK: -9.1 +/- 0.97 D). BSCVA, UCVA, and refractions were collected prospectively in both series. RESULTS: Every index of BSCVA, UCVA, predictability of refraction, and stability of refraction studied favored the ICL over the LASIK procedure. All but one of the indices (UCVA % 20/40 or better) were statistically significant in at least half of the time periods studied. At 6-month follow-up, both the loss of two or more lines (ICL: 0%; LASIK: 2%; p = 0.05) and gain of two or more lines (ICL: 7%; LASIK: 3%; p = 0.04) of BSCVA were better with the ICL. Similarly, efficacy outcomes with the ICL were better with predictability (attempted versus achieved +/-1.0 D) of the ICL at 90%; 76% with LASIK (p < 0.001). In this highly myopic series, UCVA 20/20 or better was 50% with ICL compared with 35% with LASIK (p < 0.001). No serious complications occurred in either series of cases. CONCLUSIONS: The ICL was safer and more effective than LASIK and appears to be a viable alternative to corneal refractive excimer surgery in the treatment of moderate to high myopia.

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. The range of the refractive errors was -1.5 to -12.0 diopters. Corneal topography using Orbscan II (Bausch & Lomb) and pachymetry were obtained preoperatively and 1 week and 1, 2, and 3 months postoperatively. The patients were divided into 4 groups based on the residual stromal bed thickness: Group 1, 145 eyes with less than 250 microm; Group 2, 129 eyes with 250 to 300 microm; Group 3, 76 eyes with 300 to 350 microm; and Group 4, 13 eyes with more than 350 microm. They were also grouped by the ablation percentage per total corneal thickness: Group A, 16 eyes with less than 10%; Group B, 166 eyes with 10% to 20%; Group C, 146 eyes with 20% to 30%; and Group D, 35 eyes with more than 30%. RESULTS: The increase in the forward shift of the posterior corneal surface postoperatively correlated with the residual corneal bed thickness and the ablation ratio per total corneal thickness. There were no statistically significant changes in the postsurgical forward shift of the posterior corneal surface if the residual corneal thickness remained greater than 350 microm or the ablation percentage was less than 10%. CONCLUSIONS: Increased forward shift of the posterior corneal surface is common after myopic LASIK and correlates with the residual corneal thickness and the ablation percentage per total corneal thickness. An excessively thin residual corneal bed or a large ablation percentage may increase the risk of iatrogenic complications.

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 20.0 diopters (D) of myopia participating in the U. S. Food and Drug Administration clinical trial of the ICL for myopia. INTERVENTION: Implantation of the ICL. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis (Lens Opacity Classification System III), subjective satisfaction, and symptoms. RESULTS: Twelve months postoperatively, 60.1% of patients had a visual acuity of 20/20 or better, and 92.5% had an uncorrected visual acuity of 20/40 or better. Patients averaged a 10.31-line improvement in UCVA, 61.6% of patients were within 0.5 D, and 84.7% were within 1.0 D of predicted refraction. Only one case (0.2%) lost > 2 lines of BSCVA. Gains of 2 or more lines of BSCVA occurred in 55 cases (11.8%) at 6 months and 41 cases (9.6%) at 1 year after ICL surgery. Early and largely asymptomatic, presumably surgically induced anterior subcapsular (AS) opacities were seen in 11 cases (2.1%); an additional early AS opacity (0.2%) was seen because of inadvertent anterior chamber irrigation of preservative-containing solution at surgery. Two (0.4%) late (> or = 1 year postoperatively) AS opacities were observed. Two (0.4%) ICL removals with cataract extraction and intraocular lens implantation have been performed. Patient satisfaction (very/extremely satisfied) was reported by 92.4% of subjects on the subjective questionnaire; only four patients (1.0%) reported dissatisfaction. Slightly more patients reported an improvement at 1 year over baseline values for the following subjective symptoms: quality of vision, glare, double vision, and night driving difficulties. Only a 3% difference between pre-ICL and post-ICL surgery was reported for haloes. CONCLUSIONS: The results support the safety, efficacy, and predictability of ICL implantation to treat moderate to high myopia.

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. FDA clinical trial for myopia. LOCS III assessment of lens opacities, clinically significant cataract, ICL vaulting (clearance between ICL and crystalline lens), and secondary ICL-related surgeries were the main outcome measures. Mean follow-up in the V3 series was 30.7 +/- 10.0 months (range 10.8 to 49.3 mo) and in the V4 series, 17.3 +/- 6.9 months (range 0.25 to 38.5 mo). RESULTS: Incidence of anterior subcapsular opacities was significantly higher with the V3 vs. V4 ICL (12.6% vs. 2.9%, P<.001). The difference was largely due to the higher rate of late-appearing opacities (> or = 1 year after surgery; 9.2% vs. 0.6%, P<.001). The V3 group had a greater proportion of eyes with poor vault (23.6% vs. 4.3%, P<.001) and the presence of poor vault was highly associated with the development of late anterior subcapsular opacities (P<.001). Clinically significant cataract was more frequent in the V3 vs. V4 ICL (9.2% vs. 0.8%, P<.001), as was cataract extraction (6.9% vs. 0.2%, P<.001), and need for ICL replacement (5.7% vs. 1.1%, P<.001). Differences in opacity rate between the V3 and V4 designs were not due to differences in postoperative follow-up. CONCLUSION: Implantation of the currently used V4 Staar Surgical model ICL resulted in significantly less anterior subcapsular opacities, clinically significant cataracts, and secondary ICL-related surgery.