LASIK for -6.00 to -12.00 D of myopia with up to 3.00 D of cylinder using the ALLEGRETTO WAVE: 3- and 6-month results with the 200- and 400-Hz platforms.

PURPOSE: To report the refractive results after LASIK for high myopia and cylinder at one center with one surgeon comparing two laser platforms. METHODS: A total of 206 eyes of 121 patients were treated for -6.00 to -12.00 diopters (D) of spherical equivalent refractive error with up to 3.00 D of cylinder. All eyes underwent LASIK with the ALLEGRETTO WAVE 200-Hz (n=141) or 400-Hz (n=65) laser (Alcon Laboratories Inc) between 2003 and 2009. Corneal flaps were created with the IntraLase femtosecond laser (Abbott Medical Optics) at an intended thickness of 100 or 110 µm in all cases. RESULTS: At 3- and 6-month follow-up in the 200-Hz group, 77% (109/141) and 86% (121/141) of eyes, respectively, were within ±0.50 D of intended correction. In the 400-Hz group, 98.5% (64/65) and 100% (65/65) of eyes were within ±0.50 D of intended correction at 3 and 6 months postoperatively. At 3- and 6-month follow-up, 84% (119/141) and 77% (109/141) of eyes, respectively, in the 200-Hz group and 80% (52/65) and 92% (60/65) of eyes, respectively, in the 400-Hz group had 20/20 or better uncorrected distance visual acuity. At 6-month follow-up, refractive predictability and visual acuity were statistically superior in eyes in the 400-Hz group (chi square, P<.01). No eyes underwent retreatment as a secondary procedure during the time of analysis. CONCLUSIONS: LASIK with the ALLEGRETTO WAVE 200- and 400-Hz laser is effective and predictable for the treatment of high myopia with astigmatism in appropriately selected patients. The acuity and predictability of refractive results may be slightly better when using the 400-Hz platform.

LASIK for mixed astigmatism using the ALLEGRETTO WAVE: 3- and 6-month results with the 200- and 400-Hz platforms.

PURPOSE: To report the refractive results after LASIK for mixed astigmatism at one center with one surgeon comparing two laser platforms. METHODS: A total of 137 eyes of 69 patients were treated with LASIK for mixed astigmatism up to 3.33 diopters (D) using either the ALLEGRETTO WAVE 200- or 400-Hz laser (Alcon Laboratories Inc) between April 2006 and December 2009. The degree of astigmatism was higher in the 400-Hz group. Corneal flaps were created with the IntraLase femtosecond laser (Abbott Medical Optics) in all cases. RESULTS: The refractive outcomes with both laser systems were statistically similar. At 6 months, 78% of eyes had 20/20 or better uncorrected distance visual acuity (UDVA) with all but one eye achieving 20/30 or better UDVA. At 6 months, 10% of eyes treated with the 200-Hz system lost one line of corrected distance visual acuity (CDVA) whereas no eyes treated with the 400-Hz system lost any lines of CDVA. Residual astigmatism was <0.50 D for all eyes treated with both platforms. CONCLUSIONS: Both laser platforms provided predictable and effective treatment of mixed astigmatism in the patient populations treated, with over 90% of eyes achieving UDVA of 20/25 or better 6 months after surgery.

Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods.

PURPOSE: To identify the laser programming strategy that will achieve optimal refractive outcomes of LASIK with a topography-guided laser for eyes with a disparity between cylinder measured by manifest refraction and cylinder measured by topography. SETTING: Six surgeons at 5 clinical sites in the USA. DESIGN: Retrospective data review. METHODS: Preoperative, treatment, and postoperative data on 52 eyes that underwent topography-guided LASIK with the WaveLight EX500 Contoura® Vision excimer laser ablation profile in which the vectors representing the preoperative refractive cylinder and the cylinder measured by the WaveLight® Topolyzer™ VARIO Diagnostic Device (Vario cylinder) differed by >/= 0.50D and/or >/= 10 degrees of orientation were analyzed retrospectively. Data were contributed by six surgeons using the laser at 5 different clinical sites. Vector analysis of postoperative cylindrical refractive error and the actual laser programming strategy was used to calculate the cylindrical correction that would, theoretically, have completely eliminated postoperative refractive cylinder. This was compared to expected results using the preoperative manifest cylinder, the topographic cylinder, and the Phorcides Analytic Engine (Phorcides LLC, North Oaks MN; Phorcides). For analysis, subjects were stratified on the basis of the vector difference between Manifest and Topo cylinder (High, >0.75 D; and Low, ≤0.75 D). RESULTS: The poorest calculated theoretical outcomes were obtained with the manifest refraction (centroid: -0.43, 0.22; mean calculated error vector: 0.56 ± 0.42 D; p=ns). Better outcomes were obtained with the topographically measured refraction (centroid: 0.37, 0.02; mean calculated error vector: 0.47 ± 0.33 D; p=ns). The best outcomes were obtained with Phorcides (centroid: -0.15, 0.06; mean calculated error vector: 0.39 ± 0.28 D; p=ns). The mean error vector magnitude in the Phorcides Low group was significantly lower than for the Manifest and Topo Low groups (0.26 D vs 0.48 D and 0.33 D; p<0.01). The mean error magnitude in the Phorcides High group was nearly 0.25 D lower than for the Manifest High group (0.48 D vs 0.70 D; p<0.01), but was the same as for the Topo High group (0.48 D vs 0.48 D). CONCLUSION: Our study suggests that using the topographically measured cylinder or the cylinder selected by Phorcides will produce more desirable refractive outcomes than entry of the preoperative refractive cylinder as the basis for correction of myopia and myopic astigmatism with the WaveLight Contoura Vision excimer laser.

Prevention and management of refractive prediction errors following cataract surgery.

Patient satisfaction after modern day cataract surgery requires excellent surgical technique but increasingly demands superior refractive outcomes as well. In many cases, there exists an expectation from patients, as well as surgeons, to achieve emmetropia after cataract surgery. This is particularly true in patients electing premium intraocular lens technology to correct astigmatism and presbyopia to minimize spectacle dependence. Despite continued advances in preoperative and intraoperative diagnostics, refractive planning, and surgical technology, residual refractive error remains a primary source of dissatisfaction after cataract surgery. The need to enhance refractive outcomes and treat residual astigmatic or spherical refractive errors postoperatively becomes paramount to meeting the expectations of patients in their surgical outcome. This article reviews the potential preoperative and intraoperative pitfalls that can be the source of refractive error, the various options to enhance refractive outcomes, and potential future technologies to limit residual refractive error after cataract surgery.

Wavefront-optimized versus wavefront-guided LASIK for myopic astigmatism with the ALLEGRETTO WAVE: three-month results of a prospective FDA trial.

PURPOSE: To compare visual outcomes using the WaveLight ALLEGRETTO WAVE to administer either wavefront-optimized (standard LASIK) or wavefront-guided (custom LASIK) treatments in myopic eyes. METHODS: In this prospective, open-label, multicenter study conducted in the United States, 374 eyes were randomized by alternating enrollment to receive either wavefront-optimized or wavefront-guided LASIK treatments with this laser platform. Bilateral treatments were administered, with both eyes of each patient receiving the same treatment. Corneal flaps were created using the IntraLase femtosecond laser. RESULTS: In this FDA clinical trial, results at 3 months postoperatively revealed that 93% of eyes in both cohorts receiving either wavefront-optimized or wavefront-guided treatments attained an uncorrected visual acuity (UCVA) of 20/20 or better. Seventy-six percent of eyes with the wavefront-optimized treatment and 64% of eyes with the wavefront-guided treatment achieved UCVA of 20/16 or better. None of the eyes that received either treatment lost two lines or more of best spectacle-corrected visual acuity (BSCVA). In addition, 58% of eyes with wavefront-optimized treatment and 62% of eyes with wavefront-guided treatment gained one line or more of BSCVA. None of the eyes in either treatment group underwent retreatment. CONCLUSIONS: In the majority of eyes, no statistically significant differences were found between either treatment group in regard to visual acuity and refractive outcomes. Wavefront-guided treatments are not required in most cases with this laser, but may be considered if the magnitude of preoperative root-mean-square (RMS) higher order aberrations is >0.35 microm. In this study population, 83% of eyes had preoperative RMS higher order aberrations of <0.3 microm.

Four-year postoperative results of the US ALLEGRETTO WAVE clinical trial for the treatment of hyperopia.

PURPOSE: To evaluate the long-term refractive stability after LASIK for hyperopia with the WaveLight ALLEGRETTO WAVE Excimer Laser System. METHODS: All 151 patients enrolled in the 2000-2002 FDA study of the ALLEGRETTO WAVE laser were contacted by the investigators approximately 4 years after study completion to be evaluated for refractive stability. RESULTS: A total of 127/290 (43.8%) eyes in 68/151 (45%) patients presented for re-examination. Mean time from the examination taken at the 6-month follow-up stability endpoint in the FDA trial (Stability Exam) to the Post-Approval Exam was 3.9+/-0.39 years (range: 3.2 to 4.9 years). Stability of the manifest refraction spherical equivalent (MRSE) within +/-1.00 D or less was seen in 119/127 (93.7%) eyes. Regression of effect of >1.00 D was seen in 6/127 (4.7%) eyes and progression of effect was seen in 2/127 (1.6%) eyes. Weak correlation of refractive changes with keratometry readings were seen in eyes that underwent >2.00 to 4.00 D treatment (R=0.31) and >4.00 D treatment (R=0.33), implying corneal remodeling may have played a role in the refractive change observed. CONCLUSIONS: Refractive stability within +/-1.00 D MRSE after hyperopic LASIK with the ALLEGRETTO WAVE excimer laser was seen in 93.7% of eyes at > or =3 years after surgery compared with 6-month follow-up, supporting the conclusion in the FDA trial that refractive stability occurred by 6 months postoperatively. Refractive changes associated with keratometry changes were not significant in eyes that underwent < or =2.00-D treatment.

Non-contact confocal microscopy of the tear film in unoperated eyes.

PURPOSE: The NIDEK ConfoScan4 (CS4) is a digital scanning slit confocal microscope. The corneal structure and tear film can be viewed, magnified, measured, and photographed at magnifications up to 500x, in vivo, in a noninvasive manner. The objective of this study was to evaluate and illustrate various conditions related to dry eye using the CS4 confocal microscope with the 20x noncontact lens. METHODS: The CS4 was used to evaluate the natural tear film in 58 eyes of 29 patients with normal examinations, allergic conjunctivitis, nonspecific conjunctivitis, and dry eyes. In a subset of this patient population, subjective and objective findings were used to classify mild, moderate, and severe dry eye disease states. The usefulness of confocal microscopy as an objective tool to diagnose and manage different tear film-related ocular disease was also evaluated. RESULTS: The differences in tear film composition were visible using confocal microscopy. Photographs demonstrate confocal noncontact 20x microscopy as a diagnostic tool. CONCLUSIONS: Noncontact confocal microscopy is a valuable tool in the diagnosis and treatment of dry eye syndrome and other ocular states such as allergic and nonspecific conjunctivitis. It provides a simple and effective way to observe, classify, and treat the tear film. As investigators visualize and learn more, understanding of this structure will continue to improve.

The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye.

PURPOSE: To determine the incidence and severity of dry eye as determined by the International Task Force (ITF) scale in patients being screened for cataract surgery. PATIENTS AND METHODS: This was a prospective, multi-center, observational study of 136 patients, at least 55 years of age, who were scheduled to undergo cataract surgery. The primary outcome measure was the incidence of dry eye as evaluated by grade on the ITF scale and secondary outcome measures include tear break-up time (TBUT), ocular surface disease index score, corneal staining with fluorescein, conjunctival staining with lissamine green, and a patient questionnaire to evaluate symptoms of dry eye. RESULTS: Mean patient age was 70.7 years. A total of 73.5% of patients were Caucasian and 50% were female. Almost 60% had never complained of a foreign body sensation; only 13% complained of a foreign body sensation half or most of the time. The majority of patients (62.9%) had a TBUT ≤5 seconds, 77% of eyes had positive corneal staining and 50% of the eyes had positive central corneal staining. Eighteen percent had Schirmer's score with anesthesia ≤5 mm. CONCLUSION: The incidence of dry eye in patients scheduled to undergo cataract surgery in a real-world setting is higher than anticipated.

Transient light sensitivity after femtosecond laser flap creation: clinical findings and management.

PURPOSE: To describe the constellation of subjective and objective findings associated with unusual occurrences of photosensitivity after laser in situ keratomileusis (LASIK) with femtosecond flap creation and identify optimal management strategies. METHODS: Demographic data, laser settings, subjective complaints, clinical findings, treatment, and response to treatment were recorded for suspected cases of transient postoperative photosensitivity from 3 surgeons operating at 3 different sites. All cases were estimated for the period covering the suspected cases at each site to assess incidence. Additional cases were solicited from IntraLase users via a survey. RESULTS: For the 3 sites, 63 eyes from 33 patients were reported of a total estimated case log of 5667 (incidence, 1.1%). Average age was 41 years, and 51.7% of patients were women. Onset of symptoms ranged from 2 to 6 weeks after uneventful LASIK. All patients were treated with prednisolone acetate drops, whereas 1 surgeon also used Restasis (cyclosporine ophthalmic solution 0.05%). Patients noted improvement of symptoms within 1 week of treatment. When the raster and side-cut energy settings were lowered (by an average of 24% and 33%, respectively), significant reductions in incidence were noted. Similar findings were reported by 3 additional surgeons reporting 17 cases in the survey of IntraLase users. CONCLUSIONS: This report describes a new complication of LASIK performed with a femtosecond laser keratome that may be related to the pulse energy used for flap creation. Although there is no loss of uncorrected visual acuity, symptoms can be prolonged, especially without prompt steroid therapy. Technical advances that reduced pulse energies appear to decrease the incidence.

The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.

OBJECTIVE: The aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. METHODS: This was a single-center, 6-month, open-label, Phase IV study. Patients with bilateral dry eye disease and a symptom score of ≥2 on the Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index score of >12, at least one eye with Schirmer's score <10 mm/5 minutes, and central corneal staining graded as ≥2 on the Ora Calibra™ Corneal and Conjunctival Staining Scale were enrolled. Cyclosporine ophthalmic emulsion 0.05% (Restasis(®)) was instilled twice daily in each eye. The primary efficacy endpoints were ocular surface staining and visual function at 6 months. Secondary outcome measures included Schirmer's test, tear film breakup time, symptoms, and adverse events. RESULTS: A total of 40 patients with the mean age of 59.4 years (range, 40-78 years) were enrolled; 35 (87.5%) were female and 37 (92.5%) completed the study. At 6 months, inferior corneal, central corneal, total corneal, and total ocular surface fluorescein staining were significantly improved from baseline in both eyes (P<0.001). Patient responses on the Ocular Surface Disease Index showed significant improvement in blurred vision and visual function related to reading, driving at night, working with a computer or bank machine, and watching television (P≤0.041). At 6 months, 35.1% of patients achieved ≥5 mm improvement and 18.9% achieved ≥10 mm improvement in the average eye Schirmer score. Mean tear film breakup time improved by >50% in both eyes (P>0.001). Patients reported significant improvement in ocular discomfort and dry eye symptoms (P<0.001). No patients discontinued treatment because of stinging or any other ocular adverse event. CONCLUSION: Dry eye patients with difficulties with day-to-day visual function demonstrated improvement in both signs and symptoms of dry eye and reported improved visual function after 6 months of treatment with cyclosporine ophthalmic emulsion 0.05%.

Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in situ keratomileusis.

PURPOSE: To compare laser in situ keratomileusis (LASIK) results obtained with the femtosecond laser (IntraLase Corp.) to those obtained using 2 popular mechanical microkeratomes. SETTING: Private practice, Greensboro, North Carolina, USA. METHODS: This retrospective analysis compared LASIK outcomes with the femtosecond laser to those with the Carriazo-Barraquer (CB) microkeratome (Moria, Inc.) and the Hansatome microkeratome (Bausch & Lomb, Inc.). The 3 groups were matched for enrollment criteria and were operated on under similar conditions by the same surgeon. RESULTS: There were 106 eyes in the IntraLase group, 126 eyes in the CB group, and 143 eyes in the Hansatome group. One day postoperatively, the uncorrected visual acuity (UCVA) results in the 3 groups were similar; at 3 months, the UCVA and the best spectacle-corrected visual acuity results were not significantly different. A manifest spheroequivalent of +/-0.50 diopter (D) was achieved in 91% of eyes in the IntraLase group, 73% of eyes in the CB group, and 74% of eyes in the Hansatome group (P<.01). IntraLase flaps were significantly thinner (P<.01) and varied less in thickness (P<.01) than flaps created with the other devices. The mean flap thickness was 114 microm +/- 14 (SD) with the IntraLase programmed for a 130 microm depth, 153 +/- 26 microm with the CB using a 130 microm plate, and 156 +/- 29 microm with the Hansatome using a 180 microm plate. Loose epithelium was encountered in 9.6% of eyes in the CB group and 7.7% of eyes in the Hansatome group but in no eye in the IntraLase group (P =.001). Surgically induced astigmatism in sphere corrections was significantly less with the IntraLase than with the other devices (P<.01). CONCLUSIONS: The IntraLase demonstrated more predictable flap thickness, better astigmatic neutrality, and decreased epithelial injury than 2 popular mechanical microkeratomes.

Subjective assessment of mesopic visual function after laser in situ keratomileusis.

The authors' study evaluated subjective reports of mesopic visual function after LASIK for spherical and spherocylindrical myopia and evaluated whether age, pupil size, treatment amount, residual postoperative refractive error, or other factors correlated with subjective findings. Preoperative, 3-month, and 6-month subjective patient questionnaires were administered. Results for questions about glare with night driving and glare with bright lights were tallied and evaluated using standard statistical methods. The results indicated that subjective reports of mesopic visual function after myopia LASIK improve overall. Worsened symptoms are most likely to occur in eyes with poor refractive outcomes. Correction of residual refractive errors may improve night driving and glare symptoms after LASIK.

Health claims database study of cyclosporine ophthalmic emulsion treatment patterns in dry eye patients.

BACKGROUND: Dry eye is a multifactorial, symptomatic disease associated with ocular surface inflammation and tear film hyperosmolarity. This study was designed to assess patterns of topical cyclosporine ophthalmic emulsion 0.05% (Restasis®) use in dry eye patients and determine if there were any differences in use based on whether dry eye is physician-coded as a primary or nonprimary diagnosis. METHODS: Records for adult patients with a diagnosis of dry eye at an outpatient visit from January 1, 2008 to December 31, 2009 were selected from Truven Health MarketScan® Research Databases. The primary endpoint was percentage of patients with at least one primary versus no primary dry eye diagnosis who filled a topical cyclosporine prescription. Data analyzed included utilization of topical corticosteroids, oral tetracyclines, and punctal plugs. RESULTS: The analysis included 576,416 patients, accounting for 875,692 dry eye outpatient visits: 74.7% were female, 64.2% were ages 40-69 years, and 84.4% had at least one primary dry eye diagnosis. During 2008-2009, 15.9% of dry eye patients with a primary diagnosis versus 6.5% with no primary diagnosis filled at least one cyclosporine prescription. For patients who filled at least one prescription, the mean months' supply of cyclosporine filled over 12 months was 4.44. Overall, 33.9% of dry eye patients filled a prescription for topical cyclosporine, topical corticosteroid, or oral tetracycline over 2 years. CONCLUSION: Patients with a primary dry eye diagnosis were more likely to fill a topical cyclosporine prescription. Although inflammation is key to the pathophysiology of dry eye, most patients seeing a physician for dry eye may not receive anti-inflammatory therapies.