Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial.

BACKGROUND: Trabeculectomy is the "gold standard" initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. METHODS: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. DISCUSSION: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019.

Higher Order Aberrations in Femtosecond Laser-Assisted Versus Manual Cataract Surgery: A Retrospective Cohort Study.

PURPOSE: To evaluate differences in higher order aberrations (HOAs) between femtosecond laser-assisted cataract surgery (FLACS) and manual cataract surgery. METHODS: In this retrospective cohort study, consecutive patients undergoing FLACS or manual cataract surgery with implantation of an intraocular lens from January 2017 to February 2018 were recruited. Patients underwent aberrometry testing at least 2 months postoperatively. The primary endpoint was internal coma < 0.32 µm, and secondary outcomes included patient-reported vision quality. Generalized estimating equations accounting for within-patient correlation were used for analysis. RESULTS: A total of 57 eyes underwent FLACS (mesopic pupil size: 4.74 ± 1.37 mm) and 50 eyes underwent manual cataract surgery (pupil size: 4.99 ± 1.24 mm). The proportion of eyes reaching internal coma < 0.32 µm was significantly greater following FLACS (54 of 57 eyes, 94.7%) relative to manual cataract surgery (39 of 50 eyes, 78.0%) (odds ratio [OR] = 5.08, 95% confidence interval [CI] = 1.24 to 20.85, P = .024). The median internal coma was 0.10 µm for FLACS and 0.12 µm for manual cataract surgery (P = .005). There were no significant differences in vision quality between treatments (P = .40). All eyes (n = 15) with satisfaction scores of 0 to 10 had internal coma < 0.20 µm, compared to those with scores of 11 to 20 (27 of 29 eyes, 93.1%), 21 to 30 (19 of 30 eyes, 63.3%), and > 30 (8 of 15 eyes, 53.3%) (P < .001). The average internal coma increased by a greater amount for manual cataract surgery than for FLACS for every increase in mesopic pupil size > 5.75 mm. CONCLUSIONS: More eyes achieved internal coma < 0.32 µm following FLACS compared to manual cataract surgery. However, this does not account for improved patient-reported vision quality. There was a correlation between internal coma and patient-reported satisfaction, and eyes with excellent patient satisfaction all had internal coma < 0.20 µm. [J Refract Surg. 2019;35(2):102-108.].

Comparison of prednisolone acetate 1.0% and difluprednate ophthalmic emulsion 0.05% after cataract surgery: Incidence of postoperative steroid-induced ocular hypertension.

PURPOSE: To compare intraocular pressure (IOP) outcomes between 2 common, commercially available corticosteroid drops: difluprednate ophthalmic emulsion 0.05% and prednisolone acetate 1.0%. SETTING: TLC Eyecare and Laser Centers, Jackson, Michigan, USA. DESIGN: Retrospective chart review. METHODS: The outcomes of consecutive patients who had uneventful cataract surgery from April 2013 to September 2013 and used prednisolone acetate postoperatively were compared with the outcomes of consecutive patients who had uneventful cataract surgery from June 2014 to October 2014 and used difluprednate postoperatively. RESULTS: The study included 224 eyes treated with prednisolone acetate 4 times daily for 30 days and 225 eyes treated with difluprednate 2 times daily for 30 days. There was no significant difference between the 2 groups in age, sex, or race. In addition, the mean IOP did not differ significantly between the prednisolone acetate group and the difluprednate group at the preoperative measurement or 1 month after surgery, nor was there a difference in the 1-month change in IOP between groups. No association was found between the incidence of a 6 mm Hg or higher increase in IOP 1 month after surgery and steroid treatment. One month postoperatively, 4 eyes in the prednisolone acetate group and 5 eyes in the difluprednate group had an IOP higher than 21 mm Hg. CONCLUSIONS: There was no significant difference in the mean IOP or percentages showing IOP elevation between eyes treated with difluprednate and eyes treated with prednisolone acetate after cataract surgery. This was likely the result of low-frequency dosing and short duration of steroid use.

Prediction of Glaucomatous Visual Field Progression Using Baseline Clinical Data.

PURPOSE: To develop a prediction model for glaucomatous visual field progression using easily accessible baseline clinical data. PATIENTS AND METHODS: We collected baseline data of 613 consecutive patients with open-angle glaucoma from 2001 to 2003. The rate of visual field progression was calculated using the Visual Field Index (VFI) of routine follow-up examinations until 2010. Baseline data of 333 patients from 3 hospitals were used to develop a model to predict the rate of VFI progression using a linear regression analysis and univariate preselection (P<0.1) of 8 candidate predictors. The performance of the model was investigated using R, the area under the receiver-operating characteristic curve, and calibration plots. The prediction model was internally validated using bootstrapping and externally validated in 280 patients from 2 other hospitals. RESULTS: After a mean follow-up period of 5.8 years of all 613 eyes, the mean rate of VFI progression was -1.6% per year. The final model contained the following predictors: age, baseline intraocular pressure, and baseline visual field status. During model development, 10.3% of the observed variation in VFI rates was explained by the model. The area under the receiver-operating characteristic curve was 0.76 when the prediction model was used to detect a VFI rate of -3% per year or worse, which decreased to 0.71 at external validation. CONCLUSIONS: Although our prediction model could explain only a small amount of the variance in visual field progression, it may offer the possibility to identify subgroups of treated patients with high rates of visual field progression, thereby providing an opportunity to select those patients for more intensive treatment.

Prevalence of end-of-life visual impairment in patients followed for glaucoma.

PURPOSE: To assess the prevalence of end-of-life visual impairment in patients followed for glaucoma. METHODS: Data of 122 patients followed for glaucoma who had died between July 2008 and July 2010 and who had visited the ophthalmology outpatient department of a large non-academic Dutch hospital were collected from the medical files. Sixty-one patients had open-angle glaucoma (OAG), and 61 patients were suspect for glaucoma or had ocular hypertension (OHT). Visual impairment was defined as a mean deviation value <-15 dB or a Snellen visual acuity <0.3 (20/60) of the better eye. We determined the number of patients with visual impairment on the last patient visit before death and investigated its main explanations. RESULTS: Overall, the mean age at death was 81.8 years after a mean follow-up period of 9.2 years. Seventy-three per cent of all patients had their last visit in the year preceding death. In OAG, 16 patients (26%) had an end-of-life visual impairment. In nine patients (15%), this was caused by glaucoma. Eight of them had substantial visual loss at the initial visit. Six (10%) impaired OAG cases were mainly explained by ocular comorbidity, and there was an equal contribution of comorbidity and glaucoma in one case. Five glaucoma suspects or patients with OHT (8%) were visually impaired at death and these were all caused by ocular comorbidity. CONCLUSION: The prevalence of end-of-life visual impairment is considerable in patients with OAG. Substantial visual loss at baseline is an important contributing factor. In glaucoma suspects or patients with OHT, the prevalence is lower and can be attributed to ocular comorbidity.

An evidence-based review of prognostic factors for glaucomatous visual field progression.

PURPOSE: To examine which prognostic factors are associated with glaucomatous visual field progression. DESIGN: Knowledge of prognostic factors helps clinicians to select patients at risk of glaucomatous visual field progression and intensify their treatment. METHODS: By consulting relevant databases, we identified 2733 articles published up to September 2010, of which 85 articles investigating prognostic factors for visual field progression in patients with open-angle glaucoma (OAG) were eligible. We summarized results for each factor in tables, noting the direction of the association between the prognostic factor and progression, and the accompanying P value. Four authors, working blind to the factors, independently judged the extent to which a prognostic factor was associated with glaucomatous visual field progression. If there were different associations for normal-tension glaucoma (NTG) studies, they were judged separately. Consensus was reached during group meetings. MAIN OUTCOME MEASURES: A ranking of all studied prognostic factors for glaucomatous visual field progression according to their likelihood of being prognostic. RESULTS: A total of 103 different prognostic factors were investigated in 85 articles. The following factors were clearly associated with glaucomatous visual field progression: age, disc hemorrhages (for NTG), baseline visual field loss, baseline intraocular pressure (IOP), and exfoliation syndrome. An association was unlikely for family history of glaucoma, atherosclerosis, systemic hypertension, visual acuity, sex (for NTG), systolic blood pressure, myopic refractive error (for NTG), and Raynaud's phenomenon. CONCLUSIONS: The factors we found clearly associated with progression could be used in clinical practice and for developing clinical prediction models. For many other factors, further research is necessary.

Implantation of multifocal intraocular lenses using a magnification strategy in cataractous eyes with age-related macular degeneration.

PURPOSE: To examine visual function after targeting -2.0 diopter (D) spherical equivalent (SE) when implanting a multifocal intraocular lens (IOL) in eyes with cataract and age-related macular degeneration (AMD). SETTING: Three private practices. DESIGN: Case series. METHODS: Lenses of cataractous eyes with AMD were replaced with the Acrysof Restor SN60D3 multifocal IOL, targeting an SE of -2.0 D, which yielded +5.2 D near addition. Near and distance visual acuities were examined. Patients completed a visual function questionnaire preoperatively and 6 months postoperatively. RESULTS: At 6 months, 13 patients with 20 eligible eyes were examined. The uncorrected near visual acuity improved in 18 eyes (90%) and was unchanged in 2 eyes. The corrected distance visual acuity improved in 14 eyes (70%), was unchanged in 4 eyes (20%), and decreased (≤ 3 lines) in 2 eyes (10%). All vision-related questionnaire items improved. CONCLUSION: For cataractous eyes with AMD, replacing the crystalline lens with this myopia-targeted multifocal IOL improved or maintained near vision without severely compromising distance vision. FINANCIAL DISCLOSURE: Drs. Mackool and Ernest are consultants to Alcon. Dr. Mackool is an inventor in the patent of the IOLs related to this strategy. No other author has a financial or proprietary interest in any material or method mentioned.

A new system, the LipiFlow, for the treatment of meibomian gland dysfunction.

PURPOSE: To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). METHODS: This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort. RESULTS: LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events. CONCLUSION: The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.

The influence of the assessment method on the incidence of visual field progression in glaucoma: a network meta-analysis.

PURPOSE: To study and quantify the difference in incidence of progression between methods for the assessment of glaucomatous visual field progression. METHODS: We identified 2450 articles published up to April 2009 in the following data sources: PubMed, EMBASE, and Cochrane. Ten studies covering 30 methods were included. All studies aimed to compare different methods for the assessment of glaucomatous visual field progression in the same study population. A network meta-analysis using a mixed-effects model was performed to combine within-study between-method comparisons with indirect comparisons from other studies. The summarized incidence of progression was calculated for every method, and methods were ranked according to this incidence. RESULTS: In total, methods were compared in 1040 eyes of 948 patients with glaucoma. On average, 21% of the eyes progressed. When all 30 methods were ranked, the incidence ranged from 2% to 62%. These incidences are corrected for a baseline mean deviation (MD) value of -7 decibels and a mean follow-up time of 6 years. Besides the assessment method, the incidence was only determined by the follow-up period and baseline MD value, leaving no unexplained variance in the incidence of progression. CONCLUSION: The incidence of progression varies considerably between different studies. This is mainly caused by the variety of methods used to assess progression but also by differences in follow-up time and baseline visual field loss.

The evidence base to select a method for assessing glaucomatous visual field progression.

A large number of methods have been developed for assessing glaucomatous visual field progression, but their properties have not yet been systematically evaluated. In this systematic literature review, we summarize the evidence base for selecting a method by providing answers to ten relevant questions on the variety, validity and reproducibility of methods. In total, we found 301 different methods in 412 articles. The majority of studies (54%) used the Humphrey Field Analyzer. No data have been published about the reproducibility of methods. Although there is no gold standard to assess glaucomatous visual field progression, we found evidence on validity for 48 different methods. Some methods were less capable of distinguishing between progressive and nonprogressive patients. Choosing among twelve methods is supported by some evidence of their validity. These methods still differ in sensitivity, specificity and predictive values of test results within studies comparing several methods. In conclusion, the current evidence base is not perfect. A selection should be made from a limited number of methods, according to the clinical purpose of progression assessment. Methods that quantify the rate of visual field progression seem to be the most appropriate for guiding subsequent medical actions in individual patients. Future studies should investigate whether using one method to monitor patients is superior to another method in preventing loss of quality of life.

Minimizing surgically induced astigmatism at the time of cataract surgery using a square posterior limbal incision.

Purpose. To compare the surgically induced astigmatism from clear corneal and square posterior limbal incisions at the time of cataract surgery. Methods. Surgically induced astigmatism was calculated for a set of eyes after cataract surgery using a temporal 2.2 mm square posterior limbal incision. Results were compared to similar available data from surgeons using clear corneal incisions of similar size. Results. Preoperative corneal astigmatism averaged 1.0 D and was not significantly different between the incision types. Surgically induced astigmatism with the 2.2 mm posterior limbal incision averaged 0.25 ± 0.14 D, significantly lower in magnitude than the aggregate surgically induced astigmatism produced by the 2.2 mm clear corneal incision (0.68 ± 0.49 D). Conclusion. The 2.2 mm square posterior limbal incision induced significantly less, and significantly less variable, surgically induced astigmatism relative to a similar-sized clear corneal incision. This is likely to improve refractive outcomes, particularly important with regard to premium intraocular lenses.

Effects of preoperative corneal astigmatism orientation on results with a low-cylinder-power toric intraocular lens.

PURPOSE: To evaluate refractive results with a low-cylinder-power toric intraocular lens (IOL) and the effect of preoperative corneal astigmatism orientation on results. SETTING: Private practice, Jackson, Michigan, USA. DESIGN: Comparative case series. METHODS: This retrospective review of clinical records comprised patients with 0.75 to 1.38 diopters (D) of preoperative corneal astigmatism who had uneventful cataract surgery and AcrySof T3 toric or AcrySof IQ spherical monofocal IOL implantation. Surgically induced astigmatism (SIA) was calculated for eyes with postoperative keratometry results. Postoperative refractive astigmatism between groups and subgroups was compared based on the orientation of preoperative corneal astigmatism. RESULTS: Of the eyes, 185 had a toric IOL and 138 had a spherical IOL. The mean preoperative corneal astigmatism was 1.06 D, with no significant difference between IOL groups or by axis of astigmatism. The mean SIA was 0.25 D, with no significant difference between IOL groups. The mean postoperative refractive astigmatism was statistically significantly lower in the toric IOL group than in the spherical IOL group (0.31 D versus 1.06 D; P<.001). The axis of preoperative corneal astigmatism was not a significant factor in the toric IOL group. In the spherical IOL group, the residual astigmatism was slightly higher for with-the-rule than for against-the-rule astigmatism (1.07 D versus 0.70 D; P<.001). CONCLUSIONS: The mean refractive astigmatism after cataract surgery in patients with 0.75 D to 1.38 D of corneal astigmatism was significantly lower when a toric IOL was implanted. Postoperative refractive astigmatism with the toric IOL was independent of preoperative corneal astigmatism axis orientation. FINANCIAL DISCLOSURE: Neither author has a financial or proprietary interest in any material or method mentioned.

The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study.

PURPOSE: To compare the AcrySof Toric intraocular lens (IOL) and an AcrySof spherical control IOL and to investigate rotational stability of the AcrySof Toric IOL (Alcon Laboratories, Inc., Fort Worth, TX) in subjects with cataracts and preexisting corneal astigmatism. DESIGN: Randomized, subject-masked, parallel-group, multicenter, 1-year study. PARTICIPANTS: We included 517 subjects (Toric IOL, n = 256; control IOL, n = 261). METHODS: Unilateral implantation of an AcrySof Toric or AcrySof spherical control IOL (spherical powers, 12.00-25.00 diopters [D]; cylinder powers 1.50, 2.25, or 3.00 D for corneal astigmatism correction of 0.75 to < 1.50, ≥ 1.50 to <2.00, and ≥ 2.00 D with no upper limit, respectively). No limbal relaxing incisions were permitted. MAIN OUTCOME MEASURES: Visual acuity outcomes, IOL position, patient-reported spectacle use, and safety. RESULTS: One year postoperatively, best spectacle-corrected distance visual acuity of ≥ 20/20 was 77.7% (Toric IOL) versus 69.2% (control IOL). Uncorrected distance visual acuity of 20/20 or better was 40.7% (Toric IOL) versus 19.4% (control IOL; P<0.05). Mean absolute residual refractive cylinder was 0.59 D (Toric IOL) versus 1.22 D (control IOL; P<0.0001). Mean rotation was < 4° (range, 0°-20°) for the Toric IOL. Six-month spectacle freedom was 61.0% (Toric IOL) and 36.4% (control IOL; P < 0.0001). Complications in both groups were few and were as would be expected with cataract surgery. CONCLUSIONS: Favorable efficacy, rotational stability, distance vision spectacle freedom, and safety results support the use of the AcrySof Toric IOL for patients with cataracts and corneal astigmatism. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Outcome of ABCA4 microarray screening in routine clinical practice.

PURPOSE: To retrospectively analyze the clinical characteristics of patients who were screened for mutations with the ATP-binding cassette transporter gene ABCA4 (ABCA4) microarray in a routine clinical DNA diagnostics setting. METHODS: We performed a retrospective analysis of the medical charts of 65 patients who underwent an ABCA4 microarray screening between the years 2002 and 2006. An additional denaturing gradient gel electrophoresis (DGGE) was performed in these patients if less than two mutations were found with the microarray. We included all patients who were suspected of autosomal recessive Stargardt disease (STGD1), autosomal recessive cone-rod dystrophy (arCRD), or autosomal recessive retinitis pigmentosa at the time of microarray request. After a retrospective analysis of the clinical characteristics, the patients who were suspected of STGD1 were categorized as having either a typical or atypical form of STGD1, according to the age at onset, fundus appearance, fluorescein angiography, and electroretinography. The occurrence of typical clinical features for STGD1 was compared between patients with different numbers of discovered mutations. RESULTS: Of the 44 patients who were suspected of STGD1, 26 patients (59%) had sufficient data available for a classification in either typical (six patients; 23%) or atypical (20 patients; 77%) STGD1. In the suspected STGD1 group, 59% of all expected pathogenic alleles were found with the ABCA4 microarray. DGGE led to the finding of 12 more mutations, resulting in an overall detection rate of 73%. Thirty-one percent of patients with two or three discovered ABCA4 mutations met all typical STGD1 criteria. An age at onset younger than 25 years and a dark choroid on fluorescein angiography were the most predictive clinical features to find ABCA4 mutations in patients suspected of STGD1. In 18 patients suspected of arCRD, microarray screening detected 22% of the possible pathogenic alleles. CONCLUSIONS: In addition to confirmation of the diagnosis in typical STGD1, ABCA4 microarray screening is usually requested in daily clinical practice to strengthen the diagnosis when the disease is atypical. This study supports the view that the efficiency and accuracy of ABCA4 microarray screening are directly dependent upon the clinical features of the patients who are screened.

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.

In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac.

PURPOSE: To evaluate the aqueous humor concentrations and cyclooxygenase (COX) inhibitory activities of nepafenac, amfenac, ketorolac, and bromfenac after topical ocular administration of Nevanac (nepafenac 0.1%), Acular LS (ketorolac 0.4%), or Xibrom (bromfenac 0.09%). SETTING: Five private ophthalmology practices throughout the United States. METHODS: Patients requiring cataract extraction were randomized to 1 of 3 treatment groups: Nevanac, Acular LS, or Xibrom. Patients were administered 1 drop of the test drug 30, 60, 120, 180, or 240 minutes before cataract surgery. At the time of paracentesis, an aqueous humor sample was collected and later analyzed for drug concentration. In addition, COX-1 (homeostatic) and COX-2 (inducible) inhibitory activities of nepafenac, amfenac, ketorolac, and bromfenac were determined via the in vitro measurement of prostaglandin E(2) (PGE(2)) inhibition. RESULTS: Seventy-five patients participated in the study. The prodrug nepafenac had the shortest time to peak concentration and the greatest peak aqueous humor concentration (C(max)). The C(max) of nepafenac was significantly higher than that of the other drugs (P<.05), including the higher-concentration ketorolac (0.4%). The area under the curve (AUC) of nepafenac was significantly higher (P<.05) than the AUCs of amfenac, ketorolac, and bromfenac. The combined AUCs of nepafenac and amfenac were the highest of all drugs tested (P<.05). Ketorolac showed the most potent COX-1 inhibition, whereas amfenac was the most potent COX-2 inhibitor. The PGE(2) aqueous humor levels of each study medication were highly variable; as a result, meaningful interpretation of the data was not possible. CONCLUSION: Nepafenac showed significantly greater ocular bioavailability and amfenac demonstrated greater potency at COX-2 inhibition than ketorolac or bromfenac.

Severe photic phenomenon.

A 69-year-old man who had uneventful bilateral cataract surgery with visual acuity of 20/15 without correction presented with severe dysphotopsia. Treatment with brimonidine (Alphagan) or pilocarpine did not resolve the symptoms. A multipiece silicone intraocular lens was piggybacked into the sulcus, and the patient no longer reported dysphotopsia.

Clinical results of the blue-light filtering AcrySof Natural foldable acrylic intraocular lens.

PURPOSE: To verify the safety and effectiveness of the new AcrySof Natural (Alcon Laboratories, Inc.) blue-light filtering intraocular lens (IOL), which was designed to achieve a light-transmission spectrum similar to that of the natural human crystalline lens. SETTING: Multicenter U.S. clinical trial. METHODS: In a prospective randomized patient-masked multicenter study, 150 patients received the AcrySof Natural IOL and 147 patients received the AcrySof single-piece IOL as a control. Patients with bilateral age-related cataracts who were willing and able to wait at least 30 days between cataract procedures and had verified normal preoperative color vision were eligible for the study. Standardized surgery included a 4.0 to 5.0 mm capsulorhexis and phacoemulsification. All lenses were inserted in the capsular bag, with verification of in-the-bag placement of both haptics. In all bilateral implantation cases, the same model IOL was used in each eye. Postoperatively, contrast sensitivity and color perception were measured up to 180 days and up to 1 year (for visual acuity) after implantation. RESULTS: No statistically significant differences were discovered between the 2 patient groups in visual acuity, contrast sensitivity evaluated under mesopic and photopic conditions, or the number of patients who passed the Farnsworth D-15 color perception test. There were no lens-related adverse events in either group. CONCLUSIONS: The blue-light filtering AcrySof Natural IOL was equivalent to the conventional AcrySof lens in terms of postoperative visual performance. Additional long-term clinical studies should show whether the IOL actually provides the theoretical benefits to retinal health.