Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial.

PURPOSE: To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism. DESIGN: Prospective, multicenter clinical trial. PARTICIPANTS: The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between -1.00 and -10.00 diopters (D), with manifest spherical equivalent (MSE) of up to -11.50 D and refractive cylinder of up to -3.00 D. METHODS: -Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes. MAIN OUTCOME MEASURES: Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events. RESULTS: Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from -5.39±2.30 D at baseline to -0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from -1.53±0.70 D at baseline to -0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences. CONCLUSIONS: Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.

An Evaluation of the IOLMaster 700.

OBJECTIVES: To evaluate the repeatability and reproducibility of the Carl Zeiss Meditec IOLMaster 700, which uses swept-source optical coherence tomography technology, along with its agreement with the IOLMaster 500 and Lenstar LS 900. METHODS: In a clinical practice, complete measurements were taken on one eye of 100 subjects: 51 with cataracts and 49 with clear lenses. Three sets of measurements were taken by 3 operators with three different IOLMaster 700 units, and one operator took 3 measurements with the IOLMaster 500 and the Lenstar. A random-effects model of analysis of variance was used to estimate the repeatability and reproducibility. The 95% limits of agreement (95% LoA) were calculated for all comparisons. RESULTS: Comparing the IOLMaster 700 and IOLMaster 500 in cataract patients, 95% LoA were -0.01 to +0.06 mm for axial length, -0.44 to +0.27 D for corneal power, and -0.18 to +0.17 mm for anterior chamber depth. Comparing the IOLMaster 700 and Lenstar for corneal thickness and lens thickness yielded 95% LoA of -4 to +13 µm and -0.26 to +0.41 mm, respectively. The repeatability and reproducibility limits for the IOLMaster 700 were ±0.014 and ±0.023 mm for axial length; ±0.26 and ±0.27 D for corneal power; ±7 and ±11 µm for corneal thickness; ±0.02 and ±0.02 mm for anterior chamber depth; and ±0.02 and ±0.05 mm for lens thickness, respectively. CONCLUSIONS: There was good agreement between the IOLMaster 700 and comparator instruments and superior or equivalent precision. Some differences were noted, but not considered clinically meaningful.

Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes.

PURPOSE: To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. DESIGN: Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). PARTICIPANTS: Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit. METHODS: The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. MAIN OUTCOME MEASURES: For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events. RESULTS: At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant. CONCLUSIONS: The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.

Somatosensory perception of running shoe mass.

Running shoes are often marketed based on mass. A total of 50 young adult males participated across two separate experiments to determine how well they could perceive the relative masses of five different running shoes using hands versus feet. For the foot portion, subjects were blindly fitted with the shoes and asked to rank their masses individually using visual analogue scales (VAS) and verbal rankings. For the hand portion, two different methods were used, one presenting all shoes simultaneously and the other presenting the shoes individually. Verbal accuracy and VAS scores correlated across subjects for the hand and foot, but accuracy in mass perception by the feet was 30% compared to 92% or 63% by the hand (depending on the method). These results indicate the foot perceives mass poorly compared to the hand, and that consumers' perception of shoe mass may come more from handling shoes versus wearing them.

Intraoperative, real-time aberrometry during refractive cataract surgery with a sequentially shifting wavefront device.

PURPOSE: To introduce a new sequential wavefront device with rapid sampling that can be used as an intraoperative, real-time aberrometer/refractometer for immediate diagnosis and management of refractive outcomes during cataract surgery. METHODS: A unique wavefront device uses a rotating prismatic mirror to rapidly shift the incident wavefront emanating from the eye through an aperture for analysis of a sequentially sampled wavefront segment. The sampled segment is then focused onto a quad detector that localizes its angular displacement of the sampled segment's wavefront gradient. Although the device's capability is higher for other applications, the wavefront is herein rapidly sampled at 200 Hz (frames/second), with a 2-mm aperture that moves along a 5-mm outer diameter annulus to capture a real-time analysis of refractive error for intraoperative application (ie, an intraoperative wavefront movie). The prototype wavefront device has been miniaturized into a narrow profile attachment that can be fixed to an operating microscope. In pilot analysis, several eyes undergoing cataract surgery were analyzed to determine both the qualitative and quantitative change in refraction with surgical intervention in an effort to document and improve outcomes intraoperatively. RESULTS: Clinical application of the device was easily implemented without changing or limiting the working distance, magnification, or illumination of the surgeon's ergonomics intraoperatively. The real-time wavefront outcome was visualized overlaying a live eye image, presenting the refractive error both qualitatively and quantitatively. Qualitative representation of spherical refractive error was seen as a circle, cylinder as a thin ellipse, and emmetropia as a dot. Localization of lower-order aberrations with a practical sample rate of 200 frames/ second enables a real-time visualization of qualitative refractive data coaxially aligned with the eye image and quantitatively as sphere, cylinder, and axis at the bottom of the screen. Practical evaluation of residual cylinder prior to and during limbal relaxing incision placement, rotational accuracy during toric intraocular lens alignment, and refractive effect of subtle surgical maneuvers were all achieved with this device. CONCLUSION: Real-time, intraoperative refraction and visualization is possible with a new sequential wavefront device attached to the operating microscope. The precision and accuracy of intraoperative documentation and refinement of outcomes is likely to be enhanced, making this an important future tool for optimizing cataract surgery outcomes.

Fulminant Vasculitis Complicated by ST-Elevation Myocardial Infarction and Stroke.

Acute coronary syndrome is a rare complication of vasculitis. We present a case of fulminant medium-vessel vasculitis, most likely PAN, complicated by STEMI and stroke, that was successfully treated with percutaneous revascularization, high-quality stroke care, and immunosuppression. This case highlights the importance of prompt diagnosis and treatment of vasculitis and the recognition of coronary and cerebral ischemia as potentially serious complications.

Defocus Curve and Patient Satisfaction with a New Extended Depth of Focus Toric Intraocular Lens Targeted for Binocular Emmetropia or Slight Myopia in the Non-Dominant Eye.

PURPOSE: To evaluate the defocus curve and patient satisfaction after implantation of an extended depth of focus (EDOF) toric IOL when both eyes were targeted for emmetropia and when the non-dominant eye was targeted for mini monovision (-0.50D). METHODS: A prospective unmasked randomized clinical trial in three clinical practices in the USA. Subjects presenting for routine cataract surgery were assigned to one of two groups, both receiving bilateral toric EDOF lenses. One group had the non-dominant eye targeted for slight myopia (-0.50D). Measures of interest were the postoperative defocus curve and reported patient satisfaction and visual disturbances. RESULTS: Questionnaire and defocus curve data were available from 37 subjects in the Emmetropia group, while the mini monovision group included questionnaire data from 39 subjects and valid defocus curve data from 14 subjects. Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of -1.50 D to -3.00 D. Reported spectacle wear and satisfaction were not significantly different between groups at any distance, but more patients in the mini monovision group reported the ability to function comfortably without glasses at near and overall (near p = 0.02, overall p < 0.01). Halos and starbursts were the two phenomena reported most often for both groups, with reported starbursts slightly more common in the mini monovision group. CONCLUSIONS: A slightly myopic correction in the non-dominant eye improved binocular near vision by 0.5 to 1.0 lines based on defocus curve data. Patients reported better functional vision, but with a slight increase in reported starbursts in the mini monovision group.

Evaluating Rotational Stability of an Extended Depth of Focus Toric Intraocular Lens Using a Slit Lamp and Image-Based Analysis.

PURPOSE: To evaluate the rotational stability of a toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software. SETTING: Three clinical practices in the USA. DESIGN: Prospective unmasked randomized clinical trial. METHODS: Subjects presenting for routine cataract surgery that were interested in improved near vision received toric EDOF lenses (TECNIS Symfony® Toric) in both eyes. The measures of interest in the current analysis were the change in orientation of the IOL between 1 day, 1 month and 3 months postoperative. Orientation was measured at the microscope on the day of surgery, and with the slit lamp at all other visits. Day 1, 1-month and 3-month images of the lens orientation were captured with a slit lamp camera. Differences in orientation were recorded and analyzed. RESULTS: A total of 150 eyes had IOL orientation data available. Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees. The percentage of lenses exhibiting rotation of ≤5 degrees between any measured time points was 97% or higher. Results were similar, but significantly more variable, when IOL orientation was measured at the slit lamp. CONCLUSION: The toric EDOF lens evaluated here demonstrated rotational stability that exceeded the prior ANSI standard. The best method to determine IOL orientation changes was through image analysis. .

Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study.

Purpose: To compare, in a masked manner, a novel cross-linked hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears with respect to safety and effectiveness in healing epithelial defects created for photorefractive keratectomy (PRK). Methods: This was a randomized, reading center-masked, exploratory study. Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect) were randomized post-PRK to treatment with OBG 8 times daily for 3 days, followed by 4 times daily for 11 days (Group 1); OBG 4 times daily for 14 days (Group 2); or BCL and artificial tears (Control). A masked reading center used image analysis of digital slit lamp photos of the fluorescein-stained cornea to evaluate defect size during the 14-day postoperative follow-up period. Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing on day 3 postoperatively, whose defect remained closed. Safety assessments included findings for adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED™) Questionnaire, slit lamp, intraocular pressure, and fundus examinations. Results: The proportion of patients with complete healing at 3 days was 73.3%, 86.7%, and 66.7% of patients in Groups 1, 2, and Control, respectively. On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control. No safety concern arose. SPEED scores were not significantly different across groups. Conclusion: OBG offers a well-tolerated and effective therapy for quickly reepithelializing the cornea following trauma, disease, or surgery.

A prospective, contralateral eye study comparing thin-flap LASIK (sub-Bowman keratomileusis) with photorefractive keratectomy.

PURPOSE: To determine the differences in the visual results, pain response, biomechanical effect, quality of vision, and higher-order aberrations, among other parameters, in eyes undergoing either photorefractive keratectomy (PRK) or thin-flap LASIK/sub-Bowman keratomileusis (SBK; intended flap thickness of +/-100 microm and 8.5-mm diameter) at 1, 3, and 6 months after surgery. DESIGN: A contralateral eye pilot study. PARTICIPANTS: Fifty patients (100 eyes) were enrolled at 2 sites. METHODS: The mean preoperative spherical refraction was -3.66 diopters (D) and the mean cylinder was -0.66 D for all eyes. Eyes in the PRK group underwent 8.5-mm ethanol-assisted PRK, whereas in eyes in the SBK group, an 8.5-mm, (intended) 100-microm flap was created with a 60-kHz IntraLase femtosecond laser (Advanced Medical Optics, Santa Ana, CA). All eyes underwent a customized laser ablation using an Alcon LADARVision 4000 CustomCornea excimer laser (Alcon Laboratories, Fort Worth, TX). MAIN OUTCOME MEASURES: Preoperative and postoperative tests included best spectacle-corrected visual acuity, uncorrected visual acuity (UCVA), corneal topography, wavefront aberrometry, retinal image quality, and contrast sensitivity. Patients completed subjective questionnaires at each visit. RESULTS: One- and 3-month UCVA results showed a statistically significant difference: SBK, 88% 20/20 or better vs. 48% 20/20 or better for PRK. At 6 months, UCVA was 94% 20/20 or better for PRK and 92% for SBK. At 1 and 3 months, the SBK group had lower higher-order aberrations (coma and spherical aberration; P

Spinal IgG4-Related Hypertrophic Pachymeningitis with Spinal Cord Compression: Case Report and Literature Review.

BACKGROUND: Back pain is a leading reason for patients to seek medical attention. Although musculoskeletal causes are common, patients can also present with rarer etiologies. CASE DESCRIPTION: A 50-year-old man presented with 2 months of isolated upper back pain initially suspected to be secondary to overuse muscular strain. During the next 3 months, his pain worsened, and he developed lower extremity dysesthesia and subjective weakness, despite normal neurological examination findings. Nonrevealing laboratory workup included normal muscle enzymes, C-reactive protein, urinalysis, and human leukocyte antigen B27. Magnetic resonance imaging revealed a normal brain but a hypointense C7-T5 epidural mass, prompting a neurosurgical recommendation for laminectomy with evacuation of the suspected hematoma. His symptoms fully and promptly resolved after a 5-day course of prednisone 40 mg. When his symptoms recurred within 2 months, he underwent T4-T5 laminectomy with biopsy of a mass confluent with the dura mater. Initial pathological examination revealed fibrotic tissue of unclear etiology with polyclonal lymphoid infiltrate but no malignant cells, vasculitis, or granulomas. After months of recurrent, steroid-responsive symptoms, he presented to the rheumatology clinic. Repeat spinal magnetic resonance imaging demonstrated progression of epidural thickening with suspected spinal cord compression. Previous biopsy samples were then immunostained for IgG4, revealing focally dense IgG4-positive plasma cells, up to 29 cells per high power field, consistent with spinal IgG4-related hypertrophic pachymeningitis. He began rituximab therapy with a prednisone taper and demonstrated symptomatic and neurologic improvement with successful withdrawal from corticosteroids. CONCLUSIONS: To the best of our knowledge, the present case represents the 12th reported case of spinal IgG4-related hypertrophic pachymeningitis. An early diagnosis and treatment could prevent progression to permanent neurological impairment and functional disability.

Prospective, randomized, eye-to-eye comparison of a new silicone corneal shield versus conventional bandage contact lens after photorefractive keratectomy.

PURPOSE: To compare uncorrected distance visual acuity (UDVA) and patient-reported outcomes with a new silicone corneal shield and a conventional bandage contact lens (BCL) after photorefractive keratectomy (PRK). SETTING: Stanford Eye Laser Center (Palo Alto, California) and Slade & Baker Vision (Houston, Texas). DESIGN: Prospective randomized cohort study. METHODS: Standardized bilateral wavefront-guided or wavefront-optimized PRK was performed in 25 patients with myopia. Each patient's dominant eye was randomized to either a silicone corneal shield or a conventional BCL, which was placed at the conclusion of surgery. The contralateral eye was assigned the other intervention. The UDVA and patient-reported outcomes were measured preoperatively, 1 hour after surgery, and at 1, 2, 3, 4, and 7 days postoperatively. RESULTS: At 1 day postoperatively, the mean logarithm of the minimum angle of resolution (logMAR) UDVA was 0.04 ± 0.16 (SD) in the silicone corneal shield group and 0.29 ± 0.22 in the BCL group (P < 0.01). At 7 days postoperatively, the mean logMAR UDVA was 0.09 ± 0.17 in the silicone corneal shield group and 0.23 ± 0.24 in the BCL group (P = .01). At 1 day through 3 days postoperatively, the patients reported greater pain, discomfort, foreign body sensation, and heavy eyelid in the eye with the silicone corneal shield. There was no statistically significant difference in the survey outcomes between the two groups at 4 days and 7 days postoperatively. CONCLUSIONS: The new silicone corneal shield was safe and effective, with faster visual recovery and a trend toward quicker epithelialization; however, it might be less comfortable than a conventional BCL.

Extended depth-of-focus toric intraocular lens targeted for binocular emmetropia or slight myopia in the nondominant eye: Visual and refractive clinical outcomes.

PURPOSE: To compare the visual and refractive outcomes with a diffractive toric extended depth-of-focus (EDOF) intraocular lens (IOL) when both eyes are targeted for emmetropia and the nondominant eye is targeted for slight myopia. SETTING: Three clinical practices, United States. DESIGN: Prospective case series. METHODS: Patients having routine cataract surgery with bilateral Tecnis Symfony toric EDOF IOL implantation were assigned to 1 of 2 groups. In 1 group, the nondominant eye was targeted for -0.50 diopter (D) (mini-monovision). Assessments included uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (4 m), intermediate (66 cm), and near (40 cm) and the postoperative residual refractive error. RESULTS: Forty patients were enrolled in each group, with 1 dropout. The mean postoperative residual refractive astigmatism was 0.25 D in both groups, with no statistically significant difference. The mean residual refractive astigmatism was 0.50 D or lower in 92% of eyes (72/78) in the mini-monovision group and 95% of eyes (74/78) in the emmetropia group 3 months postoperatively. The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001). Binocular uncorrected acuity was not statistically significantly different between groups at 4 m (-0.03 versus -0.01; P = .33) or 66 cm (0.06 versus 0.04; P = .34) but was statistically significant at 40 cm (0.25 versus 0.19; P = .03). CONCLUSIONS: The EDOF toric IOL provided functional distance, intermediate, and near vision. A slight monovision approach appears to improve near visual acuity.

Wavefront-guided excimer laser ablation using photorefractive keratectomy and sub-Bowman's keratomileusis: a contralateral eye study.

PURPOSE: To explain the basic science and clinical evidence that has led to the development of a new technique in corneal refractive surgery--sub-Bowman's keratomileusis (SBK). METHODS: A comprehensive review of the literature and report of a contralateral eye study of 50 patients (100 eyes) enrolled at 2 sites (25 patients per site) and randomized according to the dominant eye was conducted. All eyes underwent a wavefront-guided refractive correction using the Alcon LADARVision4000 System. In one eye, an 8.5-mm, ETOH-assisted photorefractive keratectomy (PRK) was performed. In the second eye, an 8.5-mm, 100-microm flap was attempted using a 60 kHz IntraLase FS femtosecond laser. Pre- and postoperative tests included best spectacle-corrected visual acuity, uncorrected visual acuity, corneal topography, wavefront aberrometry, retinal image quality, contrast sensitivity, and biomechanical response of the cornea. Patients completed subjective questionnaires at each follow-up. RESULTS: Clinical results demonstrate that SBK provides quicker visual recovery, although the data suggest that the 3- and 6-months results are similar in terms of visual outcomes. Reichert Ocular Response Analyzer results demonstrate that its impact on the cornea is similar to PRK. CONCLUSIONS: This study indicates that SBK provides the visual recovery of a LASIK procedure with the Optical Response Analyzer results similar to PRK.

Clinical Outcomes Using a Novel Image-Guided Planning System in Patients With Cataract and IOL Implantation.

PURPOSE: To determine the proportion of eyes with preexisting astigmatism achieving 0.50 diopters (D) or less of residual refractive cylinder 3 months after either implantation of toric intraocular lenses (IOLs) or corneal incisions using the VERION system (Alcon Laboratories, Inc., Fort Worth, TX) measurement module and digital markers for microscope (M) and laser (L). METHODS: Eyes with preexisting astigmatism in the intention-to-treat population were divided into four groups. Eyes in the no laser treatment group underwent toric IOL implantation with the measurement module, vision planner, and digital marker M (n = 102). Eyes in the other three groups underwent implantation of toric (n = 110), monofocal (n = 88), or multifocal (n =100) IOLs using the measurement module, vision planner, and digital marker M, including digital marker L, and LenSx laser (Alcon Laboratories, Inc.). The proportions of eyes achieving 0.50 D or less of relative refractive cylinder and with manifest refraction spherical equivalent (MRSE) deviating 0.50 D or less from the target outcome were evaluated at 3 months. RESULTS: The percentages of eyes achieving 0.50 D or less of relative refractive cylinder in the non-laser-treated, toric, monofocal, and multifocal groups at 3 months were 71.6%, 74.5%, 62.5%, and 71.0%, respectively. The percentages of eyes in these four groups with MRSE accuracies deviating 0.50 D or less from the target at 3 months were 69.6%, 80.0%, 77.3%, and 82.0%, respectively. CONCLUSIONS: The image-guided surgical planning system was effective in accurate correction of preexisting astigmatism in eyes undergoing refractive cataract surgery with IOL implantation, as shown by residual refractive astigmatism and MRSE at 3 months. [J Refract Surg. 2018;34(12):824-831.].

Evaluation of a multifunctional femtosecond laser for the creation of laser in situ keratomileusis flaps.

PURPOSE: To characterize the performance of a multifunctional femtosecond laser system (Lensx) for the creation of laser in situ keratomileusis (LASIK) flaps. SETTING: Two surgical sites in the United States. DESIGN: Prospective case series pilot study. METHODS: Patients with myopia or hyperopia who were eligible for femtosecond laser-initiated LASIK surgery with corrected distance visual acuities (CDVA) correctable to at least 20/25 were enrolled. Central flap thickness accuracy (desired versus achieved) and precision (flap thickness standard deviation) were measured using anterior segment optical coherence tomography. Flap dissection quality, stromal bed quality, and amount of opaque bubble layer (OBL) formation were graded during surgery, and the refractive outcomes were evaluated postoperatively at 1-month and 3-month follow-ups. RESULTS: The study comprised 30 patients (58 eyes). At 3 months postoperatively, the flap thickness accuracy was 1.3 µm ± 2.6 (SD). A total of 78.3% of flaps were lifted with no resistance and 16.7% were lifted with minimal resistance using a blunt instrument. All (100%) stromal beds were determined to have a very smooth surface (grade 5 on a 0 to 5 scale). No OBL was observed in 73.3% of eyes; 26.7% of eyes showed an OBL occurring on less than 24% of the stromal bed surface. At 3 months postoperatively, most eyes (84.5%) had an uncorrected distance visual acuity of 20/20 and 98% had a CDVA of 20/20. The most common ocular adverse event was punctate keratitis (11.7%). CONCLUSION: The multifunctional femtosecond laser system effectively created LASIK flaps that were high quality, accurate, and precise.

Toric Implantable Collamer Lens for moderate to high myopic astigmatism.

PURPOSE: To assess the efficacy of the Toric Implantable Collamer Lens (ICL) to treat moderate to high myopic astigmatism. DESIGN: Prospective nonrandomized clinical trial. PARTICIPANTS: Two hundred ten eyes of 124 patients with between 2.38 and 19.5 diopters (D) of myopia (spherical equivalent [SE]) and 1 to 4 D of astigmatism participating in the United States Food and Drug Administration clinical trial of the Toric ICL. INTERVENTION: Implantation of the Toric ICL. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, and postoperative complications. RESULTS: At 12 months postoperatively, the proportion of eyes with 20/20 or better UCVA (83.1%) was identical to the proportion of eyes with preoperative 20/20 or better BSCVA (83.1%); 76.5% had postoperative UCVA better than or equal to preoperative BSCVA. The mean manifest refractive cylinder dropped from 1.93 D (+/-0.84) at baseline to 0.51 D (+/-0.48) postoperatively, a 73.6% decrease in astigmatism. Although only 21.0% of eyes had 1-D refractive cylinder preoperatively (none less), 91.4% of cases had < or =1 D of cylinder postoperatively. Furthermore, 65.6% had < or =0.5 D and 40.9% had < or =0.25 D of refractive cylinder postoperatively. Mean manifest refraction SE (MRSE) improved from -9.36 D (+/-2.66) preoperatively to 0.05 D (+/-0.46) postoperatively. A total of 76.9% of eyes were predicted accurately to within +/-0.5 D, 97.3% to within +/-1.0 D, and 100% to within +/-2.0 D of predicted MRSE. Postoperatively, 37.6% of eyes had a BSCVA of 20/12.5 or better, compared with a preoperative level of 4.8%. Furthermore, BSCVA of 20/20 or better occurred in 96.8% postoperatively, compared with 83.1% preoperatively. Mean improvement in BSCVA was 0.88 lines; there were 3 cases (1.6%) that lost > or =2 lines of BSCVA after 12 months postoperatively, whereas 18.9% of cases improved by > or =2 lines. A total of 76.4% of cases gained > or =1 lines of BSCVA, whereas only 7.5% of cases lost the equivalent amount. Three ICL removals were performed without significant loss of BSCVA, and 1 clinically significant lens opacity was observed. CONCLUSION: The results support the efficacy and predictability of Toric ICL implantation to treat moderate to high myopic astigmatism. Important safety concerns were not identified.

Customized LASIK treatment for myopia: relationship between preoperative higher order aberrations and refractive outcome.

PURPOSE: To analyze the effect of preoperative higher order aberrations on postoperative sphere and cylinder outcome. METHODS: Three hundred thirty myopic eyes (mean: -3.32 +/- 1.54 diopters [D], range: -1.0 to -7.0 D) treated with customized ablation using the Technolas 217z laser (Bausch & Lomb) were followed through 6 months after LASIK. Pre- and postoperative visual acuity, higher order root mean square (RMS), third order RMS, and spherical aberration were compared to study the safety and efficacy of the treatment. The relationship between preoperative higher order aberrations and manifest refraction after LASIK was analyzed. RESULTS: Following LASIK, 91.5% of eyes obtained an uncorrected visual acuity of > or = 20/20 and 70.3% of eyes obtained 20/16 without retreatment; 99% had a best spectacle-corrected visual acuity of > or = 20/20 (75.9% of eyes were within +/- 0.50 D). Mean value of significant increase in postoperative higher order aberrations was 0.12 +/- 0.18 microm (P<.0001). Increased spherical aberration was associated with increased myopia treatment (P<.0001). Greater positive spherical aberration after LASIK was significantly correlated to postoperative hyperopia (overcorrection). Change in third order RMS was significantly correlated to change in spherical equivalent refraction among eyes with postoperative astigmatism (P<.0001). CONCLUSIONS: With the Bausch & Lomb Technolas 217z Zyoptix software, treatment of higher order aberrations, especially third order (coma and trefoil) and spherical aberration, significantly improved postoperative refractive status.

Clinical evaluation of the Crystalens AT-45 accommodating intraocular lens: results of the U.S. Food and Drug Administration clinical trial.

PURPOSE: To evaluate the 12-month U.S. phase II clinical trial results of the Crystalens AT-45 (eyeonics, Inc.) intraocular lens (IOL) used to provide uncorrected distance, intermediate, and near visual acuities in patients having cataract extraction and to compare in a substudy the contrast sensitivity and near visual acuity in patients with the Crystalens AT-45 IOL and those receiving a standard IOL. SETTING: Fourteen clinical sites throughout the U.S. for efficacy and 3 non-U.S. sites for safety and efficacy. METHODS: Patients 50 years or older had small-incision cataract extraction with implantation of the Crystalens AT-45 IOL. Unilateral implantation was followed by fellow-eye implantation. Postoperatively, uncorrected distance, near, and intermediate visual acuities were determined. Near and intermediate visual acuities were tested through a distance correction to eliminate potential pseudoaccommodative effects of residual myopia and corneal cylinder. A substudy tested contrast sensitivity under mesopic conditions with and without glare, as well as visual acuity in a subset of Crystalens AT-45 patients and a control group receiving a standard IOL. RESULTS: A total of 263 patients participated in the U.S. clinical trial and had 1 year of follow-up. Near visual acuities through the distance correction of 20/40 (J3) or better, monocularly and bilaterally, respectively, were seen in 90.1% and 100%; intermediate near visual acuities were seen in 99.6% and 100%. More than half the bilaterally implanted Crystalens AT-45 patients achieved uncorrected near acuity of 20/25 (J1) or better through the distance correction, and 84% achieved 20/32 (J2) or better. In the substudy, monocular near vision through the distance correction of 20/25 (J1) or better was seen in 50.4% with the Crystalens AT-45 IOL and in 4.7% with the standard IOLs. Mesopic contrast sensitivity results with and without glare for the Crystalens AT-45 were similar to those with standard monofocal IOLs. Nearly all patients (74 patients; 97.3%) who bilaterally were within 0.50 diopter of plano postoperatively achieved 20/32 (J2) or better uncorrected near, intermediate, and distance visual acuities. CONCLUSIONS: The Crystalens AT-45 accommodating IOL provided good uncorrected near, intermediate, and distance vision in pseudophakic patients. Contrast sensitivity with the Crystalens AT-45 was not diminished relative to standard monofocal IOLs, and near and intermediate visual performance was significantly better than with standard IOLs.