Work Intensity of Postoperative Care Following Implantation of Presbyopia-Correcting versus Monofocal Intraocular Lenses.

Purpose: To compare the work intensity of postoperative care following implantation of presbyopia-correcting intraocular lenses (IOLs) to that of standard monofocal IOLs. Patients and Methods: This open-label, multicenter, comparative study retrospectively reviewed the case records of cataract surgery patients who underwent bilateral implantation of either presbyopia-correcting IOLs (presby-IOL group; N=177) or standard monofocal IOLs (monofocal group; N=177). Outcome measures included the total time the patient spent in the office, number of visits, mean duration of visits, and the number of procedures and diagnostic tests during the first postoperative year. Outcome measures were compared between the first 90 days and days 91-365 after surgery. Results: Mean (±SD) time spent in the office during the first postoperative year was 5:50 ± 3:35 hours (H:MM) over 6.6 ± 2.9 visits in the presby-IOL group, compared to 3:38 ± 1:36 hours over 4.9 ± 1.6 visits in the monofocal IOL group (p <0.001). During the first 90 days, a presby-IOL patient spent 40 minutes longer in the office than a monofocal IOL patient (3:39 ± 1:38 hours vs 2.59 ± 1:13 hours) (p <0.001). During days 91-365, time in the office was 1:32 hours longer (p <0.001), and the mean visit duration was 8 minutes longer for the presby-IOL patients (p=0.002) than those with monofocal IOL. In addition, the presby-IOL patients underwent more procedures and diagnostic tests (p ≤0.001) as compared with standard monofocal cataract surgery patients. Conclusion: Patients implanted with presbyopia-correcting IOLs require significantly more clinic time, diagnostic testing, and procedures postoperatively as compared with standard monofocal cataract surgery patients.

Wavefront-guided myopic laser in situ keratomileusis with a high-resolution Hartmann-Shack aberrometer and a new nomogram.

PURPOSE: To evaluate visual, refractive, aberrometric, and patient-reported outcomes of wavefront-guided (WFG) myopic laser in situ keratomileusis (LASIK) using a high-resolution Hartmann-Shack aberrometer (iDesign Advanced WaveScan system) with a new nomogram and to determine whether the new nomogram resolved the mild undercorrection that occurs with the manufacturer's default settings. SETTING: Three private LASIK practices. DESIGN: Prospective, open-label, noncomparative, multicenter study. METHODS: One hundred ninety eyes of 95 patients underwent bilateral WFG LASIK for the correction of myopia or myopic astigmatism. A new nomogram was used, which effectively adjusted the wavefront-measured refraction sphere up or down to equal the manifest refraction sphere. Patients were followed up for 6 months. RESULTS: Eighty-four patients completed the final follow up. At 6 months, 162 (96.4%) of 168 eyes achieved monocular uncorrected distance visual acuity of 20/20 or better. No eye lost 2 or more lines of corrected distance visual acuity. The safety and efficacy indices were 1.12 and 1.09, respectively; 164 (98%) of 168 eyes had manifest refraction spherical equivalent within ±0.50 diopters (D) of emmetropia, and 154 (92%) of 168 eyes had residual manifest refractive astigmatism of 0.50 D or less. Fewer patients experienced burning, stinging, soreness, and irritation postoperatively than preoperatively. Eighty-one (96%) of 84 patients reported improved quality of life. CONCLUSIONS: WFG myopic LASIK using a high-resolution Hartmann-Shack aberrometer and a new nomogram resolved the undercorrection with the manufacturer's default settings. The treatment was safe and effective with excellent visual and refractive outcomes, high patient satisfaction, and improved quality of life.

Toxic peripheral keratopathy: a syndrome in laser refractive surgery.

This retrospective observational case series describes a clinical syndrome in laser refractive surgery. Five eyes of 4 patients with noninflammatory peripheral corneal opacification in the period immediately after photorefractive keratectomy or laser in situ keratomileusis were identified and the charts abstracted. Peripheral stromal opacification, localized corneal thinning, irregular astigmatism leading to a decrease in corrected visual acuity, and gradual clearing were characteristic findings. Gradual clearing occurred without treatment in all eyes over a period of 2 weeks to 12 months. This syndrome has similarities to central toxic keratopathy but occurs in the peripheral cornea. We refer to the syndrome as toxic peripheral keratopathy, the cause of which is unknown.

Lack of progression of ectasia seven years after LASIK in a highly myopic keratoconic eye.

PURPOSE: To report a patient with clinically evident keratoconus with a preoperative spherical equivalent refraction of more than -10.00 diopters (D) who underwent successful LASIK with no evidence of progression of ectasia 7 years after surgery. METHODS: Interventional case report. RESULTS: A patient with clinically evident keratoconus in his left eye underwent bilateral LASIK. Preoperative best spectacle-corrected visual acuity (BSCVA) in the left eye was 20/25 with a manifest refraction of -8.50 -3.25 x 126. Seven years later he presented complaining of progressive loss of visual acuity in his left eye. A significant posterior subcapsular and nuclear cataract was present in the left eye. There was no evidence of ectasia on topography. Cataract surgery was performed and BSCVA retumed to 20/20. CONCLUSIONS: LASIK can be successful in some eyes with keratoconus, even when deep ablations are performed. It is not appropriate to conclude from this case that LASIK is safe in eyes with keratoconus. This case raises an important question: why do some eyes with normal preoperative topography develop ectasia after LASIK, whereas other eyes with significant keratoconus preoperatively remain stableert ke after LASIK?

Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial.

OBJECTIVE: To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia. DESIGN: Prospective, open-label, noncomparative, multicenter clinical trial. PARTICIPANTS: A total of 684 adults with axial myopia from -4.5 diopters (D) to -22 D were enrolled: 662 in the primary analysis group and 22 under compassionate use protocol expansion. Efficacy data are based on the 662 first eyes implanted. INTERVENTION: Implantation of the Artisan/Verisyse phakic intraocular lens. MAIN OUTCOME MEASURES: Efficacy measures included uncorrected distance visual acuity (UCVA), refractive predictability and stability, patient satisfaction, and contrast sensitivity. Safety measures were best spectacle-corrected visual acuity (BSCVA), intraocular pressure, slit-lamp observations, endothelial cell density (ECD), complications, and adverse events. RESULTS: At 3 years, UCVAs for first eyes were 20/40 or better in 84.0% (194/231) and 20/25 or better in 51.9% (120/231). Of first eyes, 71.7% to 76.7% were within 0.50 D of target refraction and 93.1% to 95.0% were within 1.0 D at 6 months and later. Best spectacle-corrected visual acuity was 20/40 or better for 99% to 100% of first eyes from the 1-month visit through 3 years. At 3 years, 54% of first eyes gained >/=1 lines of BSCVA, and 7.5% lost >/=1 lines of BSCVA. The mean change in ECD from baseline to 3 years was -4.8%+/-7.8%, with a 2.4% loss between 2 and 3 years. One site had a mean cell loss of -5.0% (P = 0.023), and the others combined had a mean cell loss of 1.7%+/-5.4%. For a cohort of 57 eyes with ECD data for all visits, the mean change from baseline was -3.8%+/-9.8% over 3 years. Approximately half (31/59) of the adverse events and preventative repositionings were among the first 10 cases performed by each investigator. CONCLUSIONS: The Artisan/Verisyse phakic IOL provides excellent refractive outcomes; endothelial cell loss within a mean of 5.0% over 3 years, or 1.8% per year; and few complications.

Methicillin-resistant Staphylococcus aureus infectious keratitis following refractive surgery.

PURPOSE: To elucidate risk factors, clinical course, visual outcomes, and treatment of culture-proven methicillin-resistant Staphylococcus aureus (MRSA) infectious keratitis following refractive surgery. DESIGN: Interventional case series. METHODS: Multicenter chart review of 13 cases of MRSA keratitis following refractive surgery and literature review. RESULTS: Thirteen eyes of 12 patients, nine of whom were either healthcare workers or exposed to a hospital surgical setting, developed MRSA keratitis following refractive surgery. All patients presented with a decrease in visual acuity and complaints of pain or irritation in the affected eye. Common signs on slit-lamp biomicroscopy were corneal epithelial defects, focal infiltrates with surrounding edema, conjunctival injection, purulent discharge, and hypopyon. All patients were diagnosed with infectious keratitis on presentation and treated with two antibiotics. All eyes were culture-positive for MRSA. CONCLUSIONS: According to a computerized MEDLINE literature search, this is the first case series of MRSA infectious keratitis following refractive surgery, the first reports of MRSA keratitis after refractive surgery in patients with no known exposure to a healthcare facility, the first report of MRSA keratitis after a laser in situ keratomileusis (LASIK) enhancement, and the first reports of MRSA keratitis after prophylaxis with fourth-generation fluoroquinolones. MRSA keratitis is a serious and increasing complication following refractive surgery. Patients with exposure to a healthcare environment should be considered at additional risk for developing MRSA keratitis. However, in addition, surgeons should now be vigilant for community-acquired MRSA. Prompt identification with culturing and appropriate treatment of MRSA keratitis after refractive surgery is important to improve visual rehabilitation.

Central toxic keratopathy: description of a syndrome in laser refractive surgery.

PURPOSE: To describe the clinical spectrum of a syndrome in laser refractive surgery, which we call central toxic keratopathy, and to present cases that illustrate the range of this syndrome. DESIGN: Retrospective observational case series. METHODS: Eyes with noninflammatory central corneal opacification in the immediate postoperative period after photorefractive keratectomy (PRK) or laser in situ keratomileusis (LASIK) were identified, and the charts abstracted. RESULTS: Twenty-three eyes of 14 patients were identified who developed central corneal opacification three to nine days after laser refractive surgery. Nineteen of these eyes had LASIK and four had PRK. All eyes had central corneal opacification in the area of laser treatment that extended posteriorly from the interface into the stromal bed (in the case of LASIK eyes). The opacification persisted a minimum of two months to a maximum of 18 months before clearing. Nine eyes developed postoperative hyperopia of greater than 2 diopters. Pre- and postoperative best-spectacle corrected acuity was available on 19 eyes; one of these eyes lost two lines of corrected acuity, and two other eyes lost one line. Eighteen of 19 LASIK eyes had diffuse lamellar keratitis preceding the onset of corneal opacification. CONCLUSIONS: Central toxic keratopathy is characterized by noninflammatory central corneal opacification with a significant hyperopic shift. The opacification gradually clears over a period of months, leaving the eye hyperopic. Enhancement is indicated to treat residual hyperopia and remove residual striae. Topical or oral corticosteroid treatment is not indicated. The cause of central toxic keratopathy is unknown.

Laser in situ keratomileusis in patients with autoimmune diseases.

PURPOSE: To evaluate the safety of laser in situ keratomileusis (LASIK) in patients with autoimmune diseases. SETTING: Private clinical practice. METHODS: In this retrospective case series, the records of patients who had LASIK at the Maloney Vision Institute between June 1, 1998, and October 1, 2004, were reviewed for a history of autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, scleroderma, inflammatory bowel disease, Graves' disease, Reiter's syndrome, and Hashimoto's disease. The records were reviewed for corneal and scleral complications of autoimmune disease after LASIK. RESULTS: Forty-nine eyes of 26 patients with inactive or stable autoimmune disease were identified. No eye developed corneal thinning, melting, persistent epithelial defect, persistent keratitis, scleral thinning, scleritis, or scleromalacia. CONCLUSION: Laser in situ keratomileusis may be a reasonable option in patients with well-controlled or inactive autoimmune disease.

Treating astigmatism after a free laser in situ keratomileusis cap by rotating the cap.

Induced astigmatism and loss of best corrected visual acuity are complications of inadvertently rotating a free cap of laser in situ keratomileusis. It is possible to determine the angle of rotation from the induced astigmatism and correct the astigmatism by lifting and rotating the cap to an astigmatically neutral position.

The effect of LASIK on best-corrected high-and low-contrast visual acuity.

PURPOSE: To evaluate the effects of laser in situ keratomileusis (LASIK) and LASIK with concurrent astigmatic keratectomy (LASIK/AK) on high- and low-contrast visual acuity. METHODS: The setting was a university refractive surgery practice. Patients were recruited from those undergoing LASIK or LASIK/AK for myopia (>1.00 D spherical equivalent) between May 1996 and August 1997. All subjects were at least 21 years of age. Testing occurred preoperatively and 3 and 6 months after LASIK. Main outcome measures were best spectacle-corrected, high- and low-contrast visual acuity. RESULTS: For all subjects, there was a significant effect of surgery on nondilated low-contrast visual acuity (repeated measures two-way analysis of variance, p < 0.0001). Tukey's posthoc analysis showed that preoperative low-contrast visual acuity scores were significantly different from 3-month [0.08 logarithm of the minimum angle of resolution (logMAR)] and 6-month (0.11 logMAR) scores for patients undergoing LASIK and LASIK/AK. Under dilated conditions, there was a significant effect of surgery for high- and low-contrast visual acuity (analysis of variance, p < 0.0001 for both). Only changes in low-contrast visual acuity were clinically meaningful [LASIK, visual acuity reduction of 0.1 logMAR (1 line); LASIK/AK, visual acuity reduction of 0.15 logMAR (1.5 lines)]. When considering high and low myopes separately (LASIK only), the level of myopia had a significant effect on the visual acuity after surgery (analysis of variance, p = 0.01). Preoperative, dilated, low-contrast visual acuity scores for high myopes were significantly different from 3-month (0.14 logMAR) and 6-month (0.13 logMAR) scores. No differences were noted for low myopes. CONCLUSIONS: Clinically meaningful postoperative changes in low-contrast visual acuity were noted in patients undergoing LASIK and LASIK/AK under natural and dilated conditions. Postoperative, dilated, low-contrast visual acuity scores were significantly worse than preoperative scores for high myopes, but remained unchanged for low myopes.

Anterior ciliary sclerotomy for treatment of presbyopia: a prospective controlled study.

PURPOSE: To examine the safety and efficacy of anterior ciliary sclerotomy to restore accommodation in the presbyopic eye. DESIGN: Prospective nonrandomized comparative single-center clinical trial. PARTICIPANTS: Nine presbyopic subjects with no prior ocular surgery except corneal refractive procedures were enrolled. METHODS: One eye from each subject was chosen, in consultation with the patient, to undergo anterior ciliary sclerotomy. The contralateral eye of each subject served as a control. Examinations were performed preoperatively, and at 1 day, 1 week, 1 month, and 6 months after surgery. MAIN OUTCOME MEASURES: (1) Accommodative amplitude, measured by two methods, (2) Jaeger reading vision at 14 inches wearing best distance correction, (3) manifest refraction, (4) assessment of operative complications. RESULTS: For the nine study eyes, there was no statistically significant change between the average accommodative amplitude at the preoperative visit (1.11 diopter [D]) and the 1-month postoperative visit (1.19 D, P = 0.55) nor at the 6-month postoperative visit (1.31 D, P = 0.21) in the study eyes. There was no significant difference between the study and control eyes' change in accommodative amplitude at 6 months (P = 0.43). Logarithm of the minimum angle of resolution equivalent of Jaeger reading vision in the study eyes at 14 inches wearing best distance correction showed no statistically significant change from the preoperative visit (0.53 [20/70]) at the 1-month postoperative visit (0.41 [20/50], P = 0.07) or at the 6-month postoperative visit (0.48 [20/60], P = 0.22). There was no significant change in manifest refraction spherical equivalent in the study eyes at 1 and 6 months postoperatively. One eye experienced a perforation of the anterior chamber during surgery. A second eye experienced mild postoperative anterior segment ischemia manifested by sectoral iris akinesis. CONCLUSIONS: Anterior ciliary sclerotomy does not restore accommodation in presbyopic eyes and can cause significant complications.

Conductive keratoplasty for the correction of low to moderate hyperopia: U.S. clinical trial 1-year results on 355 eyes.

OBJECTIVE: To document the 1-year safety, efficacy, and stability results of 355 eyes treated in the multicenter study of conductive keratoplasty (CK) used to correct low to moderate hyperopia. DESIGN: Nonrandomized comparative (self-controlled) trial. PARTICIPANTS: Twenty surgeons at 13 centers performed CK on the eyes of all patients enrolled in a multicenter, 2-year, U.S. phase III clinical trial. Treated eyes had +0.75 to +3.00 diopters (D) of hyperopia and < or =0.75 D of cylinder. Patients were 40 years of age or older. INTERVENTION: Low-energy, high-frequency current was applied directly into the peripheral corneal stroma through a delivery tip inserted at 8 to 32 treatment spots. The number of treatment spots was increased for increasing levels of hyperopia, but the amount of radiofrequency energy remained constant. Emmetropia was intended. All eyes were treated once (there were no retreatments). MAIN OUTCOME MEASURES: Data from 355 eyes with 1 year of follow-up were analyzed for safety and stability, and data from 318 eyes were analyzed for efficacy and predictability, as well as stability and safety. All patients reported on satisfaction and quality of vision after surgery. RESULTS: At 1 year, uncorrected visual acuity was < or =20/20 in 56%, < or =20/25 in 75%, and < or =20/40 in 92% of eyes. The manifest refractive spherical equivalent refraction was within 0.50 D in 63%, within +/-1.00 D in 89%, and within +/-2.00 D in 99%. Seven of 355 eyes lost 2 lines of best spectacle-corrected visual acuity at 1 year, but no eye lost >2 lines. One eye of 355 had induced cylinder of >2.00 D. The cycloplegic refractive spherical equivalent changed a mean of 0.25 +/- 0.50 D between months 3 and 6, 0.11 +/- 0.41 D between months 6 and 9, and 0.11 +/- 0.35 D between months 9 and 12. Refractive stability seemed to be attained by 6 months and remained stable through 12 months. Histology and confocal microscopy showed deep penetration of the treatment into the stroma. Endothelial cell counts were not changed by the treatment. CONCLUSIONS: CK seems to be safe, effective, and stable for correcting low to moderate spherical hyperopia in patients 40 years old or older. Treatment penetration is deep and cylindrical in shape, and it does not damage the corneal endothelium. Uncorrected visual acuity, predictability, and stability are as good as or better than those obtained with other techniques used to correct hyperopia.

Effect of volatile compounds on excimer laser power delivery.

PURPOSE: To determine whether vapors from perfume, hairspray, oil-based paint, or water-based paint affect excimer laser beam power delivery at the corneal surface. METHODS: We measured the power delivery of an Apex Plus laser before, during, and after exposure to vapors from the following volatile compounds: three types of perfume, hair spray, an oil-based paint, and a water-based paint. A digital calorimeter was used to measure the steady-state beam power of the laser during laser discharge at the corneal plane. Multiple trials were run with each compound, and the change in laser energy over time was examined to determine if any of the compounds caused degradation of the laser optics. RESULTS: The presence of a volatile compound in the room caused no change in mean laser energy in comparison to before and after the compound was present. However, perfumes caused a progressive decline in laser beam power throughout the trials. Controlling for this progressive decline, there was no significant difference from perfume to perfume. CONCLUSIONS: None of the compounds tested caused a decline in laser beam power while present in the room. However, the presence of any perfume caused a deterioration in beam power over time, suggesting a degradation of the laser optics for all perfumes. Laser centers should consider advising their patients and staff to not wear perfumes in the laser suite.

Artisan phakic intraocular lens for myopia:short-term results of a prospective, multicenter study.

PURPOSE: To evaluate the safety and efficiency of the Artisan iris-supported phakic intraocular lens (Ophtec BV, Groningen, Netherlands) for the correction of high myopia. STUDY DESIGN: Nonrandomized, prospective, multicenter trial conducted under a United States Food and Drug Administration (FDA) Investigational Device Exemption. PARTICIPANTS: One hundred fifty-five eyes of 155 patients with myopia from -5.5 to -22.5 diopters (D) underwent implantation of an Artisan lens, as part of a phase I, II, or III FDA trial. METHODS: Eyes were examined at 1 day (154 eyes), 2 weeks (142 eyes), 2 months (130 eyes), and 6 months (84 eyes). Intraocular pressure and presence of flare and cell on slit-lamp biomicroscopy were recorded at each visit. MAIN OUTCOME MEASURES: Achieved correction, stability of spherical equivalent refraction, change in astigmatism, postoperative uncorrected vision, change in best spectacle-corrected acuity, and change in endothelial cell count. RESULTS: Mean spherical equivalent manifest refraction stabilized on postoperative day 1. Mean difference between attempted and achieved correction at 2 months was -0.32 +/- 0.95 D (mean +/- standard deviation; range, -4.42 to +2.2 D). At 6 months, 85% of eyes saw 20/40 or better uncorrected, and 90% of eyes were within 1 D of the attempted correction. Refractive astigmatism increased in 4.8% of eyes and decreased in 17% of eyes at 6 months. At 2 months, six eyes (4.8%) lost two or more lines of best spectacle-corrected visual acuity; by 6 months, no eyes lost two or more lines of best-corrected visual acuity. Endothelial cell count was unchanged at 6 months compared with the preoperative count. Nonprogressive lens opacities developed in four eyes as a result of surgical trauma. Chronic inflammation was not detected in any eye by slit-lamp biomicroscopy, nor did any eye develop angle closure or glaucoma. CONCLUSIONS: Short-term results suggest that the Artisan lens is an accurate and safe method for the correction of high myopia. Surgical skill is important in avoiding lens opacities. Longer-term data are needed to assess the impact of the lens on the endothelium, the crystalline lens, and the iris.