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.

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.

Iritis, glaucoma and corneal decompensation associated with BrightOcular cosmetic iris implant.

PURPOSE: NewColorIris cosmetic iris implants have a record of high ocular morbidity and are no longer in use. Newer generation of iris implants, BrightOcular, have patented posterior grooves in order to decrease iris touch and facilitate aqueous flow around the implant. However, little is known about their safety despite their implantations in 10 countries. METHODS: Collaborative case series of patients who had bilateral implantation of cosmetic iris implants solely for cosmetic reasons. RESULTS: 12 cases were collected being distributed as Caucasian (10) and Asian (2), women (11) and man (1) and with a mean age of 32 years. Ocular manifestations were present in 11 subjects and included anterior uveitis (10 of 12; 83.3%), glaucoma (7 of 12; 58.3%) and corneal decompensation (6 of 12; 50%). Visual acuity was normal in seven, decreased in five with two having visual recovery following explantation of the implant. Glaucoma could not be controlled medically in two patients. CONCLUSIONS: Cosmetic iris implants carry the risk of ocular damage when implanted in the anterior chamber of normal phakic eyes.

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.

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.

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

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.

The use of the femtosecond laser in the customization of corneal flaps in laser in situ keratomileusis.

PURPOSE OF REVIEW: With a growing body of work that examines the biomechanical response of the cornea following flap creation, a case has developed for creation of flaps that take advantage of the inherent strength of the stromal layers of the cornea. These flaps are thinner (+/-100 microm) and the diameter is based on the maximum ablation zone of the excimer laser. The critical component in this approach is the use of the IntraLase Femtosecond Laser (IntraLase, Irvine, California, USA) as it is the only keratome currently capable of achieving a customized flap. RECENT FINDINGS: Concern over the thickness of the corneal flap has led to a resurgence of surface ablation in order to preserve as much corneal tissue as possible. Although surface ablation does offer a higher degree of safety versus laser in situ keratomileusis (LASIK), it does not achieve the same visual results during early postoperative recovery or a high degree of patient satisfaction. New biomechanical studies comparing corneal response to various types of laser refractive procedures demonstrate that corneal flaps created with a femtosecond laser are the most stable. SUMMARY: This review is intended to summarize the primary advantages of a customized corneal flap in LASIK, as well as to review the biomechanics that support this approach.

Applications for the femtosecond laser in corneal surgery.

PURPOSE OF REVIEW: Little has changed in how corneal surgery, particularly full-thickness penetrating keratoplasty, has been performed since the introduction of the operating microscope and microsurgery more than 40 years ago. The introduction of IntraLase Enabled Keratoplasty represents the first true advancement in corneal surgery in that time. There are numerous studies that have documented the high degree of complications seen in procedures such as penetrating keratoplasty. The advent of IntraLase Enabled Keratoplasty affords an opportunity to improve the safety and effectiveness of such procedures. RECENT FINDINGS: Complications and visual outcomes remain an ongoing concern when it comes to managing patients following corneal surgery. The intensive postoperative follow up represents a significant undertaking for clinicians, staff and patients. Initial studies indicate that the use of the femtosecond laser in corneal surgery can simplify surgery, improve wound healing and lower levels of induced astigmatism. SUMMARY: This review will examine the uses of the femtosecond laser in corneal surgery, as well as early results that have been reported.

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.

Femtosecond laser flap creation for laser in situ keratomileusis: six-month follow-up of initial U.S. clinical series.

PURPOSE: To evaluate clinical performance of a femtosecond laser for flap creation in laser in situ keratomileusis (LASIK). METHODS: A prospective, consecutive series of 208 eyes (122 patients) undergoing LASIK between June 2000 and November 2000 using a femtosecond laser for creation of the corneal flap were evaluated for the incidence of complications. A subset of 114 patients who underwent myopic procedures and who were followed for 6 months was analyzed using standard outcome measures. RESULTS: In 4 of 208 eyes (1.9%), suction was lost during the procedure, causing the flap resection to be interrupted. However, in all four of these eyes the procedure was successfully performed 5 to 45 minutes after re-applanation of the eye. No postoperative complications or adverse events were observed in any treated eye. In the subgroup of 96 eyes undergoing plano correction and followed for 6 months (preoperative spherical equivalent refraction range -0.63 to -12.40 D), 98% (94 eyes) achieved uncorrected visual acuity of 20/40 or better; 94% (90 eyes) achieved 20/30 or better, 79% (76 eyes) achieved 20/25; and 55% (53 eyes) achieved 20/20 or better--all without benefit of retreatment. CONCLUSION: Femtosecond laser corneal flap creation is a safe and effective alternative to traditional mechanical microkeratomes. Standard LASIK nomograms appeared to apply equally well to the all-laser LASIK procedures. The potential for improved flap safety, reproducibility, flexibility, as well as for additional corneal applications are now being explored.