Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%.

OBJECTIVE: The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043). METHODS: Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients self-administered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity. RESULTS: Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group. CONCLUSIONS: Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.

Comparative effectiveness and cost-effectiveness of the implantable miniature telescope.

OBJECTIVE: To assess the preference-based comparative effectiveness (human value gain) and the cost-utility (cost-effectiveness) of a telescope prosthesis (implantable miniature telescope) for the treatment of end-stage, age-related macular degeneration (AMD). DESIGN: A value-based medicine, second-eye model, cost-utility analysis was performed to quantify the comparative effectiveness and cost-effectiveness of therapy with the telescope prosthesis. PARTICIPANTS: Published, evidence-based data from the IMT002 Study Group clinical trial. Ophthalmic utilities were obtained from a validated cohort of >1000 patients with ocular diseases. METHODS: Comparative effectiveness data were converted from visual acuity to utility (value-based) format. The incremental costs (Medicare) of therapy versus no therapy were integrated with the value gain conferred by the telescope prosthesis to assess its average cost-utility. The incremental value gains and incremental costs of therapy referent to (1) a fellow eye cohort and (2) a fellow eye cohort of those who underwent intra-study cataract surgery were integrated in incremental cost-utility analyses. All value outcomes and costs were discounted at a 3% annual rate, as per the Panel on Cost-Effectiveness in Health and Medicine. MAIN OUTCOME MEASURES: Comparative effectiveness was quantified using the (1) quality-adjusted life-year (QALY) gain and (2) percent human value gain (improvement in quality of life). The QALY gain was integrated with incremental costs into the cost-utility ratio ($/QALY, or US dollars expended per QALY gained). RESULTS: The mean, discounted QALY gain associated with use of the telescope prosthesis over 12 years was 0.7577. When the QALY loss of 0.0004 attributable to the adverse events was factored into the model, the final QALY gain was 0.7573. This resulted in a 12.5% quality of life gain for the average patient during the 12 years of the model. The average cost-utility versus no therapy for use of the telescope prosthesis was $14389/QALY. The incremental cost-utility referent to control fellow eyes was $14063/QALY, whereas the incremental cost-utility referent to fellow eyes that underwent intra-study cataract surgery was $11805/QALY. CONCLUSIONS: Therapy with the telescope prosthesis considerably improves quality of life and at the same time is cost-effective by conventional standards.

Comparison of clinical and patient-reported outcomes with bilateral AcrySof toric or spherical control intraocular lenses.

PURPOSE: To compare clinical and patient-reported outcomes with bilateral implantation of AcrySof toric or spherical control (Alcon Laboratories Inc) intraocular lenses (IOLs). METHODS: Patients with cataract and corneal astigmatism who previously received either an AcrySof toric IOL or an AcrySof spherical control IOL were offered implantation of the same IOL in the fellow eye. Six-month assessments included visual acuity, refractive cylinder, spectacle use, and patient satisfaction. RESULTS: The study included 62 patients (toric, n=40; control, n=22). All corneal incisions were temporal, with final mean incision sizes of 3.0 mm for the toric IOL and 3.1 mm for the spherical control IOL. A significantly greater proportion of patients with toric IOLs achieved spectacle independence for distance vision and did not require prescription glasses for near or distance vision (P=.0190). Patients with toric IOLs had significantly less residual refractive cylinder (P<.0001) and better binocular distance uncorrected visual acuity (UCVA) (P=.0014) than those with spherical control IOLs. CONCLUSIONS: Patients with bilateral AcrySof toric IOLs achieved superior spectacle freedom, residual refractive cylinder, and distance UCVA compared to patients with bilateral spherical control IOLs.

Performance of presbyopia-correcting intraocular lenses in distance optical bench tests.

PURPOSE: To compare the optical performance of 6 presbyopia-correcting intraocular lenses (IOLs) of different designs (accommodating or multifocal and aspheric or spheric). SETTING: Alcon Laboratories, Inc., Fort Worth, Texas, USA. METHODS: The optical performance of 6 IOLs were compared using modulation transfer function (MTF) and the United States Air Force 1951 Resolution Target (AFT) testing. The IOLs included 3 spheric designs (Crystalens AT-50SE, AcrySof ReSTOR SA60D3, and ReZoom NXG1) and 3 aspheric designs (AcrySof ReSTOR SN6AD3, Acri.Lisa 366D, and Tecnis ZM900). Tests were performed with a modified International Organization for Standardization (ISO) model eye with a 5.0 mm aperture at the distance focus. RESULTS: The ReSTOR aspheric IOL had the highest MTF values at all spatial frequencies, and the ReZoom IOL had the lowest MTF values at most spatial frequencies. The ReSTOR aspheric IOL produced the image with the highest resolution on the AFT test; the Tecnis and the ReZoom IOLs produced the images with the poorest resolution. The Acri.Lisa multifocal IOL was second to the ReSTOR aspheric IOL on the MTF test and had high resolution on the AFT test. The accommodating Crystalens performed poorly on the MTF test but had the second highest resolution on the AFT test. CONCLUSIONS: The AcrySof ReSTOR SN6AD3 aspheric IOL showed superior optical properties, demonstrated in MTF and AFT optical bench testing, among 6 presbyopia-correcting IOLs including the monofocal accommodating Crystalens. The Acri.Lisa IOL also performed well. The ReZoom IOL demonstrated the poorest overall optical quality.

Patient-Reported Outcomes/Satisfaction and Spectacle Independence with Blended or Bilateral Multifocal Intraocular Lenses in Cataract Surgery.

PURPOSE: To compare patient-reported outcomes (PROs) and satisfaction results after multifocal intraocular lens (IOL) implantation in three groups: two receiving bilateral implantation of the same IOL and another undergoing blended vision with two different multifocal IOLs. PATIENTS AND METHODS: A questionnaire was administered to patients who had undergone uncomplicated cataract surgery and 2 months of follow-up: the first group underwent bilateral implantation with Alcon's AcrySof ReSTOR 3.0 lens ("3.0/3.0," n=78); the second group underwent implantation with the ReSTOR ActiveFocus 2.5 or the ReSTOR ActiveFocus 2.5 toric lens ("2.5 mini-monovision," n=102); and the third group underwent implantation with the ReSTOR 2.5 lens in the dominant eye and the ReSTOR 3.0 lens in the non-dominant eye ("2.5/3.0," n=89). RESULTS: Overall PROs and satisfaction was similar among the groups. Refractive outcomes and accuracy were similar among the groups, but the 2.5 mini-monovision group reported better intermediate vision. Refractive outcome differences were not meaningful among the groups and were not a differentiating factor in PROs. Substantially fewer patients in the 2.5 mini-monovision group noticed glare and halo compared with the 3.0/3.0 group (P<0.0001, chi-square test). No new safety concerns were reported. CONCLUSION: The 2.5 mini-monovision results in a higher percentage of patients being satisfied with intermediate vision than bilateral ReSTOR 3.0 or blended vision with ReSTOR 2.5/3.0 implants, but overall PRO differences were not statistically significant.

Evaluation of the safety of prophylactic intracameral moxifloxacin in cataract surgery.

PURPOSE: To evaluate posterior and anterior segment safety of an intracameral injection of moxifloxacin 0.5% ophthalmic solution as prophylaxis for endophthalmitis in patients having cataract surgery. SETTING: Three private practices, the University of Minnesota School of Medicine, Stillwater, Minnesota, and the University of Cincinnati, Cincinnati, Ohio, USA. METHODS: In this prospective randomized combined-center open-label trial, 57 eyes of 47 patients were treated with intracameral moxifloxacin (250 mug/0.050 mL) or an equal volume of balanced salt solution at the conclusion of cataract surgery with intraocular lens implantation. Safety parameters, including visual acuity, intraocular pressure, endothelial cell counts, corneal pachymetry, corneal clarity and edema, and anterior chamber cells and flare, were evaluated preoperatively and for 3 months postoperatively. RESULTS: Optical coherence tomography results showed no statistically significant differences between the 2 treatment groups preoperatively or at 3 months. There were also no statistically significant differences between the 2 treatment groups in all other parameters preoperatively or at 1 day, 2 to 4 weeks, or 3 months. No study-related adverse events occurred. CONCLUSION: There was no increased safety risk associated with a 250 mug/0.050 mL intracameral injection of moxifloxacin, which appears to be safe in the prophylaxis of endophthalmitis after cataract surgery.

Ocular penetration and pharmacokinetics of topical gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions after keratoplasty.

PURPOSE: To compare the corneal and aqueous penetration and pharmacokinetics of gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions and their effect on corneal reepithelialization after penetrating keratoplasty. METHODS: In this randomized, open-label, parallel-controlled study, corneal and aqueous penetration and the pharmacokinetic parameters of topically applied gatifloxacin 0.3% and moxifloxacin 0.5% (2 preoperative doses of 1 drop given 5 minutes apart) were estimated by using a sparse sampling method. Corneal and aqueous samples were collected 0.25, 0.5, 1, or 2 hours after the final dose. The concentration was determined by a high-performance liquid chromatography method. Stromal Cmax:MBC50 (maximum drug concentration in serum to 50% minimum bactericidal concentration) ratios for selected ocular pathogens were also assessed. Postoperative corneal reepithelialization at days 1, 3, and 7 was evaluated and compared between groups. RESULTS: The calculated pharmacokinetic parameters were higher with moxifloxacin 0.5% than with gatifloxacin 0.3%. The stromal Cmax was 48.5 versus 15.7 microg/g (P = 0.04), and the stromal AUC0-2 (area under the concentration-time curve from 0 to 2 hours) was 30.9 versus 13.6 mug.h/g (P < 0.05). The endothelial Cmax was 76.1 versus 7.3 microg/g (P > 0.05), and the endothelial AUC0-2 was 43.9 versus 9.8 microg.h/g (P < 0.05). The aqueous Cmax was 0.9 versus 0.3 microg/mL (P > 0.05), and the aqueous AUC0-2 was 1.2 versus 0.4 microg.h/mL (P < 0.05). Stromal Cmax:MBC50 ratios were higher in the moxifloxacin 0.5% group for each pathogen tested. The corneal reepithelialization rates were comparable between groups. CONCLUSIONS: Topical preoperative moxifloxacin 0.5% achieved greater corneal and aqueous penetration than did gatifloxacin 0.3%. The clinical significance of this difference is not known. Postoperative use of these agents had similar effects on corneal reepithelialization.

A meta-analysis of Nd:YAG capsulotomy rates for two hydrophobic intraocular lens materials.

PURPOSE: The purpose of this study is to estimate and compare neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomy rates for AcrySof ® and Clareon® intraocular lens (IOL) materials using historical data from the medical literature and Alcon-sponsored clinical studies. METHODS: Clinical trials that involved the implantation of AcrySof or Clareon monofocal IOLs in subjects with cataract or presbyopia were extracted from the literature and a company repository of clinical studies. The study duration, number of eyes, and cumulative percent of Nd:YAGs for posterior capsule opacification were extracted. Bayesian random effects meta-analyses were conducted to estimate and compare outcomes for the 2 different IOL materials. RESULTS: A Bayesian random effects, meta-analysis was performed that combined a literature review of published AcrySof Nd:YAG posterior capsulotomy rates and Nd:YAG rates observed in Alcon-sponsored clinical studies of AcrySof and Clareon. Sixteen Alcon studies contained Nd:YAG data suitable for meta-analysis. Three of these Alcon studies contained results for the Clareon material (2 one-year studies, and 1 three-year study). The literature review included 50 papers from 1998 to 2015. In combination, 30,891 eyes were available for analysis and 2040 Nd:YAG procedures were reported in studies with a follow-up duration ranging in length from 4 months to 10 years. The overall probability of performing a Nd:YAG capsulotomy within a year of implant for AcrySof was 1.44% (1.11% to 1.83%) and 0.62% (0.21% to 1.38%) for Clareon. There was small improvement in the probability of Nd:YAG within a year of implant for Clareon lenses of about 0.82% with a 95% credible interval of (0.07% to 1.36%) at 1 year. Results were similar for incidence rates per 100 surgeries in a year: 0.62 (0.21 to 1.40) for Clareon, 1.46 (1.12 to 1.87) for AcrySof, and the difference was 0.84 (0.07 to 1.39) favoring Clareon. At 3 years, the overall probability of performing a Nd:YAG capsulotomy for AcrySof was 4.19% (3.24% to 5.30%) compared with only 1.82% (0.63% to 4.02%) for Clareon. CONCLUSION: A meta-analysis of Clareon multi-piece and single-piece clinical data predicts that the cumulative Clareon Nd:YAG probability will be ≤ AcrySof by 2.37% (0.18% to 3.91%) at 3 years. The results indicate that Clareon is likely to perform as well as, and possibly better than, AcrySof in terms of Nd:YAG capsulotomy rates.

Surgical placement of an optical prosthetic device for end-stage macular degeneration: the implantable miniature telescope.

OBJECTIVE: To describe the surgical procedure for placement of an implantable telescope prosthesis for end-stage age-related macular degeneration. METHODS: As part of a phase 2/3 clinical trial for patients with bilateral, irreversible age-related macular degeneration, the optimal procedure for monocular placement of the telescope prosthesis was determined. RESULTS: Because of the unique configuration of the telescope prosthesis, proper wound construction, anterior chamber management, and device insertion after phacoemulsification are critical for successful surgery. CONCLUSION: A unique surgical technique ensures appropriate placement of the telescope prosthesis, while reducing surgical trauma to the corneal endothelium.

Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation associated with cataract surgery.

PURPOSE: To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. SETTING: Twenty-one ophthalmology clinics in the United States. METHODS: A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores. RESULTS: The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P<.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P<.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001). No treatment-related ocular adverse events occurred in either group. CONCLUSION: Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.

Implantable miniature telescope for the treatment of visual acuity loss resulting from end-stage age-related macular degeneration: 1-year results.

PURPOSE: To evaluate the safety and efficacy of an implantable visual prosthetic device (IMT; VisionCare Ophthalmic Technologies, Saratoga, CA) in patients with bilateral, end-stage age-related macular degeneration (AMD). DESIGN: Prospective, open-label, multicenter clinical trial with fellow eye controls. PARTICIPANTS: A total of 217 patients (mean age, 76 years) with AMD and moderate to profound bilateral central visual acuity loss (20/80-20/800) resulting from bilateral untreatable geographic atrophy, disciform scars, or both were enrolled. METHODS: A visual prosthetic device (implantable telescope), designed to enlarge retinal images of the central visual field, was implanted monocularly in the capsular bag after lens extraction. Fellow eyes were not implanted to provide peripheral vision and served as controls. Study patients participated in 6 visual rehabilitation visits after surgery. MAIN OUTCOME MEASURES: Best-corrected distance visual acuity (BCDVA) and best-corrected near visual acuity (BCNVA), quality-of-life scores from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) and the Activities of Daily Life scale, endothelial cell density (ECD), and incidence of complications and adverse events. RESULTS: At 1 year, 67% of implanted eyes achieved a 3-line or more improvement in BCDVA versus 13% of fellow eye controls (P<0.0001). Fifty-three percent of implanted eyes achieved a 3-line or more improvement in both BCDVA and BCNVA versus 10% of fellow eyes (P<0.0001). Mean BCDVA and BCNVA improved 3.5 lines and 3.2 lines, respectively, in implanted eyes versus 0.8 lines and 1.8 lines, respectively, in fellow eyes (P<0.0001). Change in visual acuity was not related to lesion type. Mean NEI VFQ-25 scores improved by more than 7 points from baseline (P<0.01) on 7 of 8 relevant subscales. Eleven eyes did not receive the device because of an aborted procedure. Endothelial cell density was reduced by 20% at 3 months and 25% at 1 year. The decrease in ECD was correlated with postsurgical edema (P<0.0001), and there was no evidence that endothelial cell loss is accelerated by ongoing endothelial trauma after implantation. CONCLUSIONS: This implantable visual prosthesis can improve visual acuity and quality of life in patients with moderate to profound visual impairment caused by bilateral, end-stage AMD.

Multifocal intraocular lenses.

This article reviews clinical and optical data for three unique lens designs: the ReSTOR diffractive intraocular lens (IOL), the Vision Membrane, and the ReZOOM refractive multifocal IOL.

Comparison of stability between a modular intraocular lens system and a single-piece hydrophobic acrylic intraocular lens.

PURPOSE: To compare the movement of a modular intraocular lens (IOL) with that of a standard single-piece hydrophobic acrylic IOL in a human cadaver eye perfusion model. SETTING: Department of Ophthalmology, University of Colorado, Aurora, Colorado, USA. DESIGN: Experimental study. METHODS: Eight phakic human donor eyes of 4 patients had standard phacoemulsification with lens removal. One of 2 IOLs was then implanted in the capsular bag: a modular IOL (Harmoni) or a standard single-piece IOL (Acrysof SN60). Each globe was connected to a programmable perfusion pump with an in-line pressure transducer. Ultrasound biomicroscopy (UBM) was used to evaluate the anterior chamber depth (ACD) in each eye, measuring from the posterior cornea to the anterior surface of the optic at an intraocular pressure (IOP) of 5 mm Hg, 10 mm Hg, 20 mm Hg, and 30 mm Hg. Five consecutive measurements were recorded for all eyes at each pressure, and the results were averaged. RESULTS: There was significantly less movement in eyes with the modular IOL than in eyes with the single-piece IOL. The mean position of the modular IOL varied from a minimum of 0.03 mm to a maximum of 0.07 mm, and the mean position of the single-piece IOL varied from a minimum of 0.26 mm to a maximum of 0.87 mm (P = .002). CONCLUSIONS: The modular IOL showed less movement with changes in IOP than a standard single-piece IOL. Improved IOL stability might allow more accuracy in determining the effective lens position and hence improve the predictability of the refractive target. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.

Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials.

OBJECTIVE: Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). RESEARCH DESIGN AND METHODS: Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. MAIN OUTCOME MEASURES: Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). RESULTS: Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p < 0.0001). LIMITATIONS: Trials were conducted over 12 weeks; efficacy beyond this period was not assessed. CONCLUSIONS: Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.

Effect of Oral Re-esterified Omega-3 Nutritional Supplementation on Dry Eyes.

PURPOSE: To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD. METHODS: This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks. RESULTS: One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002). CONCLUSIONS: Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.

CustomCornea wavefront retreatment after conventional laser in situ keratomileusis.

PURPOSE: To evaluate the safety and efficacy of performing laser in situ keratomileusis (LASIK) retreatment using the Alcon CustomCornea system in patients who had prior myopic LASIK using conventional (nonwavefront) software. SETTING: Private practice ophthalmology clinic, St. Paul, Minnesota, USA. METHODS: In this prospective interventional trial, consecutive patients having CustomCornea retreatment following conventional LASIK were evaluated. Main outcome measures were uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refractive error, and higher-order aberrations (HOAs). RESULTS: Fourteen eyes of 10 patients were evaluated, with a mean follow-up of 5.3 months (range 6.2 to 15.4 months). Mean UCVA improved from 20/50 (logMAR) to 20/26 (P<.001). Mean spherical equivalent changed from -1.45 diopters (D) to +0.52 (P<.00001). Total aberrations, HOAs, defocus, and spherical aberration improved significantly. No eye lost a line of BCVA; 4 eyes (28.6%) gained 1 line, and 1 eye (7.1%) gained 2 lines. Ten eyes (71.4%) were within 0.5 D of emmetropia. Four eyes were overcorrected by 1.00 to 2.00 D. Risk factors for overcorrection included increased HOAs, higher spherical aberration, and not using the surgeon's offset at the time of surgery. CONCLUSIONS: Wavefront retreatment following conventional LASIK is safe and effective. Care must be taken when treating patients with higher amounts of total aberration, especially spherical aberration. Refractive results are closer to emmetropia when the surgeon's offset is used.

Quantitative assessment of ophthalmic viscosurgical device retention using in vivo confocal microscopy.

PURPOSE: To develop and apply a new laboratory method for in vivo quantitative assessment of the retention of ophthalmic viscosurgical devices (OVDs) following phacoemulsification. SETTING: Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, USA. METHODS: Studies of both eyes of New Zealand White rabbits were performed. Six OVDs were evaluated: Provisc and Healon (both sodium hyaluronate 1%), Healon5 (sodium hyaluronate 2.3%), Amvisc Plus (sodium hyaluronate 1.6%), Viscoat (sodium hyaluronate 3%-chondroitin sulfate 4%), and a new viscous-dispersive OVD, DisCoVisc (sodium hyaluronate 3%-chondroitin sulfate 4%). The OVD was injected to fill the anterior chamber and a phacoemulsification needle inserted with the tip positioned just anterior to the lens capsule. Simulated phacoemulsification was performed for 1 minute using flow rates of 20, 40, and 60 mL/min; a vacuum level of 300 mm Hg; and ultrasound power of 60% using a Legacy phacoemulsification unit. The needle was removed, and silicone oil (1000 centistokes) was injected into the anterior chamber. The distance between the corneal endothelium and the OVD-silicone oil interface was measured using in vivo confocal microscopy through-focusing (CMTF). RESULTS: Significant differences in residual thickness were found between the OVDs tested. Specifically, the residual thickness of both DisCoVisc (mean 324.5 microm +/- 163.7 [SD]) and Viscoat (251.4 +/- 100.9 microm) was significantly greater than that of Provisc (9.5 +/- 16.7 microm), Healon (3.8 +/- 11.3 microm), Healon5 (0.6 +/- 2.4 microm), and Amvisc Plus (65.6 +/- 134.0 microm) (P < .05, Dunn test). Ophthalmic viscosurgical device retention was greatest with DisCoVisc; however, there was no statistically significant difference between DisCoVisc and Viscoat in residual thickness. The flow rate did not have a significant effect on the residual thickness (Friedman 2-way analysis of variance by ranks). CONCLUSIONS: Residual OVD thickness following simulated phacoemulsification could be quantitatively measured using in vivo CMTF. The results are consistent with human surgical experience in that the dispersive OVD (Viscoat) was better retained than the cohesive compounds. DisCoVisc, a new viscous-dispersive OVD, also showed retention compared with Viscoat under the experimental conditions.

Optical performance of 3 intraocular lens designs in the presence of decentration.

PURPOSE: To study the theoretical optical performance of 3 intraocular lens (IOL) designs in the presence of IOL decentration. SETTING: Optics Center, Bausch & Lomb, Rochester, New York, USA. METHODS: A ray-tracing program was used to evaluate the effect of IOL decentration on the optical performance of 3 silicone IOLs (LI61U, Bausch & Lomb; Tecnis Z9000, Advanced Medical Optics; and a new aberration-free IOL [SofPort AO, Bausch & Lomb]) in an experimental model eye. The study was done using pupil diameters of 3.0 mm, 4.0 mm, and 5.0 mm and IOL decentrations of 0 mm, 0.25 mm, 0.50 mm, 0.75 mm, and 1.00 mm. The modulation transfer functions were computed and plotted. A Monte Carlo simulation analysis with 1000 trials with IOL decentration randomly varying for each pupil size was performed. RESULTS: Decentration of LI61U and Tecnis Z9000 IOLs led to asymmetrical higher-order aberrations that adversely affected the optical performance of the model eye; performance was not affected with the aberration-free IOL because it lacks inherent spherical aberration. Optical performance with the aberration-free IOL was better than with the LI61U IOL as the former has less spherical aberration and did not introduce other aberrations when decentered. Performance with the aberration-free IOL was better than with the Tecnis Z9000 IOL for 3.0 mm, 4.0 mm, and 5.0 mm pupils when decentration exceeded 0.15 mm, 0.30 mm, and 0.38 mm, respectively. Performance with the LI61U IOL was better than with the Tecnis Z9000 IOL for 3.0 mm, 4.0 mm, and 5.0 mm pupils when decentration exceeded 0.3 mm, 0.5 mm, and 0.5 mm, respectively. Monte Carlo simulations showed the expected postoperative results of the LI61U IOL and aberration-free IOL would be repeatable and predictable, whereas the outcomes with the Tecnis Z9000 IOL would vary widely. CONCLUSIONS: The optical performance of the model eye was not affected by decentration of an aspheric IOL designed to have no inherent spherical aberration. With decentration, the performance with the new IOL was better than with a conventional spherical IOL and an aspheric IOL designed to offset the spherical aberration of an average cornea.

Absorption of topical moxifloxacin ophthalmic solution into human aqueous humor.

PURPOSE: To investigate the absorption of moxifloxacin into human aqueous humor after administration of moxifloxacin hydrochloride ophthalmic solution, 0.5% as base. METHODS: Cataract patients were randomly allocated to receive 1 drop every 15 minutes for 4 doses before surgery (group 1) or 1 drop 4 times per day on the day before surgery plus the same preoperative regimen as group 1 (group 2). The last dose was administered 0.25, 0.50, 1, 2, or 3 hours before aqueous humor sampling. Samples from 30 patients per group were analyzed by a validated HPLC/MS/MS method. RESULTS: For group 1, the mean +/- SD C(max) was 1.50 +/- 0.75 microg/mL and occurred at 0.5 hour after dosing. The mean C(max) for group 2 was 1.74 +/- 0.66 microg/mL and was reached at 1 to 2 hours. Mean AUC(0-3h) for groups 1 and 2 were 3.16 +/- 0.29 and 4.41 +/- 0.48 microg.h/mL, respectively. The difference in AUC(0-3h) was statistically significant (P = 0.04), but the difference in Cmax was not. CONCLUSIONS: Topical moxifloxacin was well absorbed. Maximum moxifloxacin concentrations were approximately 30 times higher than the median MICs for common pathogens in bacterial endophthalmitis, indicating that either regimen may provide sufficient concentrations to prevent postoperative endophthalmitis.

Interlenticular opacification of piggyback acrylic intraocular lenses.

A dense interlenticular opacification developed 18 months after cataract surgery in a hyperopic patient with 2 acrylic piggyback intraocular lenses (IOLs) placed in the capsular bag. The patient developed a hyperopic shift with decreased vision, requiring explantation of the lenses. The dense interlenticular opacification did not allow separation of the lenses intraoperatively because of the tight adherence of the 2 IOLs.