Clinical and refractive outcomes after topography-guided refractive surgery planned using Phorcides surgery planning software.

PURPOSE: To evaluate prospectively the clinical outcomes of topography-guided laser in situ keratomileusis (LASIK) surgery performed with Contoura Vision using the Wavelight excimer laser and planned with the Phorcides Analytical Engine. SETTING: Four clinical practices in the U.S. DESIGN: Prospective single-arm interventional study. METHODS: 130 eyes of 65 patients with myopia or myopic astigmatism were enrolled in a prospective study of visual and refractive outcomes after treatment with Contoura Vision using the Wavelight EX500 excimer laser to achieve optimal distance vision. At 3 months postoperatively, uncorrected distance visual acuity (UDVA), manifest refraction, and corrected distance visual acuity (CDVA) were measured and compared with previously published studies. RESULTS: At 3 months postoperatively, 100%, 89%, and 28% of eyes achieved UDVA of 20/20, 20/15, and 20/12.5 or better, respectively. 92% of eyes had postoperative UDVA equal to or better than their preoperative CDVA. Postoperative CDVA was equal to, 1 line better, or 2 lines better than the preoperative CDVA in 53%, 40%, and 6% of eyes, respectively. Only 1 eye lost 1 line of CDVA, and no eyes lost more than 1 line of CDVA. A statistically significant decrease was noted in subjective visual complaints, including glare, halos, difficulty driving at night, reading difficulty, starbursts, fluctuation in vision, and light sensitivity. CONCLUSIONS: The Phorcides Analytical Engine can be used to optimize visual outcomes for the correction of myopia and myopic astigmatism.

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.

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.

Clinical outcomes after topography-guided LASIK: comparing results based on a new topography analysis algorithm with those based on manifest refraction.

PURPOSE: To compare short-term refractive and visual acuity outcomes after topography-guided laser in situ keratomileusis (LASIK) planned with a new topography analysis system to those based on the manifest refraction. SETTING: Four clinical sites in the United States. DESIGN: Double-arm, nonmasked, nonrandomized retrospective chart review. METHODS: This was a retrospective study of postoperative refraction and visual acuity at least 2 months after uneventful LASIK using the Contoura Vision algorithm on the WaveLight Topolyzer VARIO laser. One arm comprised eyes treated using the manifest refraction (manifest), while the other included eyes treated with an ablation profile determined by the Phorcides Analytic Engine (analytic). RESULTS: Clinical results from a matched group of 317 manifest eyes and 323 analytic eyes were available for analysis. Residual refractive results, both sphere and cylinder, were similar between groups. However, significantly more eyes had 20/16 or better (-0.1 logarithm of the minimum angle of resolution) uncorrected distance visual acuity (UDVA) (62.5% analytic, 41.3% manifest) and corrected distance visual acuity (CDVA) (77.1% analytic, 51.4% manifest) in the analytic group. All eyes but 1 had a CDVA of 20/20 or better postoperatively. The number of patients with a UDVA better than their preoperative CDVA was significantly higher in the analytic group (36.5%) relative to the manifest group (23.0%). No eye in either group lost more than 1 line of CDVA; significantly more eyes in the analytic group (42.7%) gained 1 or more lines of CDVA relative to the manifest group (30.3%). CONCLUSIONS: Using the Phorcides Analytic Engine for topography-guided surgery planning increased the likelihood of 20/16 UDVA and CDVA relative to using the manifest refraction.

Low level light therapy for the treatment of recalcitrant chalazia: a sample case summary.

PURPOSE: To evaluate the effects of low-level light therapy (LLLT) on the resolution of recalcitrant chalazia. PATIENTS AND METHODS: This was a single-site retrospective chart review of patients with chalazia, all of whom were unresponsive to previous pharmaceutical therapy or surgical intervention, who received a 15 min LLLT treatment in conjunction with a standard pharmaceutical regimen. A second treatment was applied 24 hrs to as late as 2 months if there was no evidence of progression of resolution in appearance. RESULTS: A total of 26 eyes of 22 patients with relevant history and treatment were reviewed, all with a history of prior pharmaceutical treatment for their chalazia. After a single 15 min LLLT treatment, followed by a standard pharmaceutical regimen, 46% of eyes (12/26) showed resolution of their chalazia. Resolution was noted from 3 days to one-month post-treatment. With a second treatment, the chalazia resolved in 92% of eyes (24/26). Only two eyes of the 26 (8%) required incision and curettage after LLLT treatment. CONCLUSION: The use of LLLT for the treatment of recalcitrant chalazia appears to be beneficial in patients who have failed topical and/or systemic therapy, significantly reducing the likelihood of requiring surgical intervention.

Combined low level light therapy and intense pulsed light therapy for the treatment of meibomian gland dysfunction.

PURPOSE: To evaluate the effects of combined intense pulsed light therapy (IPL) and low-level light therapy (LLLT) on clinical measures of dry eye related to severe meibomian gland disease (MGD) in subjects unresponsive to previous medical management. PATIENTS AND METHODS: This was a retrospective chart review of patients treated by 4 physicians at 3 centers. All patients were documented treatment failures with traditional pharmaceutical therapy. They all had their MGD evaluated before treatment using a grading scale (0-4), tear breakup time in seconds and the Ocular Surface Disease Index (OSDI) questionnaire. To be included, all patients had to have had a short course of adjunct pharmaceutical or device-related therapy, along with a combined IPL/LLLT treatment. As well, a second MGD evaluation with the same three measures had to have been conducted 1-3 months post treatment. RESULTS: A total of 460 eyes of 230 patients were identified for inclusion in the data set. Mean OSDI scores were significantly lower after treatment; 70.4% of patients had pretreatment OSDI scores indicative of dry eye; this dropped to 29.1% of patients after treatment. A 1-step or greater reduction in MGD grading was observed in 70% of eyes, with 28% of eyes having a 2-step or greater reduction. Tear breakup time was ≤6 seconds in 86.7% of eyes pretreatment, dropping to 33.9% of eyes after treatment. There were no ocular or facial adverse events or side effects related to the combined light treatment. CONCLUSION: The use of combined IPL/LLLT for the treatment of severe MGD appears to be beneficial in patients who have failed topical and/or systemic therapy.

Medical and surgical management of the small pupil during cataract surgery.

As cataract surgery continues to evolve, the intraoperative small pupil continues to pose challenges to even the most experienced cataract surgeon. Several steps can be taken preoperatively to decrease the chance of intraoperative miosis. Even so, the problem of miosis during cataract surgery remains a relatively common occurrence. This paper discusses many steps, both preoperative and intraoperative, that can make surgery technically easier and safer, thus maximizing the postoperative outcomes and patient satisfaction. Complications associated with small-pupil cataract surgery, risk factors for intraoperative miosis, the preoperative and intraoperative management of the small pupil during cataract surgery, and postoperative care are reviewed.

Perioperative assessment for refractive cataract surgery.

As cataract surgery has evolved into lens-based refractive surgery, expectations for refractive outcomes continue to increase. During the past decade, advancements in technology have provided new ways to measure the cornea in preparation for cataract surgery. The increasing ability to accurately estimate corneal power allows determination of the most precise intraocular lens (IOL) for each patient. New equipment measures the anterior and posterior corneal surfaces to most accurately estimate corneal power and corneal aberrations. These measurements help surgeons make the best decisions regarding the power of the IOL to be implanted during cataract surgery. However, with all the available technology, it can be difficult to decipher which of the many technologies is necessary or best for patients and for practices. This article reviews currently available options for topography, tomography, keratometry, and biometry in preparation for cataract surgery. In addition, intraoperative aberrometry and integrated cataract suites are reviewed.

Comparing wavefront-optimized, wavefront-guided and topography-guided laser vision correction: clinical outcomes using an objective decision tree.

PURPOSE OF REVIEW: This review is intended to update and educate the reader on the currently available options for laser vision correction, more specifically, laser-assisted in-situ keratomileusis (LASIK). In addition, some related clinical outcomes data from over 1000 cases performed over a 1-year are presented to highlight some differences between the various treatment profiles currently available including the rapidity of visual recovery. The cases in question were performed on the basis of a decision tree to segregate patients on the basis of anatomical, topographic and aberrometry findings; the decision tree was formulated based on the data available in some of the reviewed articles. RECENT FINDINGS: Numerous recent studies reported in the literature provide data related to the risks and benefits of LASIK; alternatives to a laser refractive procedure are also discussed. The results from these studies have been used to prepare a decision tree to assist the surgeon in choosing the best option for the patient based on the data from several standard preoperative diagnostic tests. SUMMARY: The data presented here should aid surgeons in understanding the effects of currently available LASIK treatment profiles. Surgeons should also be able to appreciate how the findings were used to create a decision tree to help choose the most appropriate treatment profile for patients. Finally, the retrospective evaluation of clinical outcomes based on the decision tree should provide surgeons with a realistic expectation for their own outcomes should they adopt such a decision tree in their own practice.

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.

Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment.

Dysfunctional tear syndrome (DTS) is a common and complex condition affecting the ocular surface. The health and normal functioning of the ocular surface is dependent on a stable and sufficient tear film. Clinician awareness of conditions affecting the ocular surface has increased in recent years because of expanded research and the publication of diagnosis and treatment guidelines pertaining to disorders resulting in DTS, including the Delphi panel treatment recommendations for DTS (2006), the International Dry Eye Workshop (DEWS) (2007), the Meibomian Gland Dysfunction (MGD) Workshop (2011), and the updated Preferred Practice Pattern guidelines from the American Academy of Ophthalmology pertaining to dry eye and blepharitis (2013). Since the publication of the existing guidelines, new diagnostic techniques and treatment options that provide an opportunity for better management of patients have become available. Clinicians are now able to access a wealth of information that can help them obtain a differential diagnosis and treatment approach for patients presenting with DTS. This review provides a practical and directed approach to the diagnosis and treatment of patients with DTS, emphasizing treatment that is tailored to the specific disease subtype as well as the severity of the condition.

Surgical correction of presbyopia.

UNLABELLED: Presbyopia is the most common refractive disorder for people older than 40 years. It is characterized by a gradual and progressive decrease in accommodative amplitude. Many surgical procedures for the correction of presbyopia exist, with additional procedures on the horizon. This review describes the prevalent theories of presbyopia and discusses the available surgical options for correction. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.

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%.

Results of topography-guided laser in situ keratomileusis custom ablation treatment with a refractive excimer laser.

PURPOSE: To evaluate the safety and effectiveness of topography-guided custom ablation treatment (T-CAT) to correct myopia and myopic astigmatism with laser in situ keratomileusis (LASIK). SETTING: Nine clinical sites in the USA. DESIGN: Prospective observational nonrandomized unmasked study. METHODS: The study comprised patients aged 18 to 65 years old with myopia or myopic astigmatism with a manifest refraction spherical equivalent (MRSE) up to -9.0 diopters (D) and astigmatism of 6.0 D or less. Patients with previous refractive surgery or abnormal topography were excluded. Corneal topographies were obtained using the Allegro Topolyzer, and laser treatment was delivered with the Allegretto Wave Eye-Q excimer laser system. Visual outcomes were evaluated postoperatively at 1 day, 1 week, and 1, 3, 6, 9, and 12 months. RESULTS: The clinical trial enrolled 212 patients (249 eyes). The T-CAT procedure significantly reduced the MRSE and cylinder, with stability of outcomes evident from 3 to 12 months after surgery. Compared with the preoperative corrected distance visual acuity (CDVA), the postoperative uncorrected distance visual acuity (UDVA) improved by 1 line or more in 30% of eyes and the postoperative UDVA was at least as good as the preoperative CDVA in 90% of eyes. Most visual symptoms improved after T-CAT. There were no significant treatment-related adverse events or loss of vision. CONCLUSION: The T-CAT procedure performed with the diagnostic device and the refractive excimer laser system safely and effectively achieved predictable refractive outcomes and reduced visual symptoms with stable results through 12 months. FINANCIAL DISCLOSURE: Dr. Stulting is a paid consultant to Alcon Laboratories, Inc., and was a medical monitor for the U.S. Food and Drug Administration (FDA) clinical trial. Dr. Fant is president of Clinical Research Consultants, Inc. (CRC), the clinical and regulatory consulting group that sponsored the FDA clinical trial. Dr. Fant and CRC were supported by Alcon Laboratories, Inc.

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.

Femtosecond laser-assisted cataract surgery.

Femtosecond laser-assisted cataract surgery provides surgeons an exciting new option to potentially improve patient outcomes and safety. Over the past 2 years, 4 unique laser platforms have been introduced into the marketplace. The introduction of this new technology has been accompanied by a host of new clinical, logistical, and financial challenges for surgeons. This article describes the evolution of femtosecond laser technology for use in cataract surgery. It reviews the available laser platforms and discusses the necessary modifications in cataract surgery technique and the logistics of incorporating a femtosecond laser into one's practice.

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.