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Purpose To demonstrate the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. Design Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. Participants Total, 615 patients in study 1 and 605 patients in study 2. Methods Patients were randomized (1:1) to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Main Outcome Measures Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. Results A significantly lower percentage of patients demonstrated ME within 90 days after surgery with nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P P = 0.001; pooled: 4.1% vs. 15.9%; P P P = 0.671) in study 2, and 55.4% versus 46.7% ( P = 0.003) in the pooled analysis. A greater percentage of patients treated with nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [ P = 0.009] and 65.4% vs. 65.9% [ P = 0.888]) and through day 60 (76.2% vs. 64.7% [ P = 0.002] and 68.9% vs. 62.1% [ P = 0.092]). No unanticipated adverse events were observed. Conclusions These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

Aging is a major risk factor for vascular cognitive impairment and dementia (VCID). Recent studies demonstrate that cerebromicrovascular dysfunction plays a causal role in the development of age-related cognitive impairment, in part via disruption of neurovascular coupling (NVC) responses. NVC (functional hyperemia) is responsible for adjusting cerebral blood flow to the increased energetic demands of activated neurons, and in preclinical animal models of aging, pharmacological restoration of NVC is associated with improved cognitive performance. To translate these findings, there is an increasing need to develop novel and sensitive tools to assess cerebromicrovascular function and NVC to assess risk for VCID and evaluate treatment efficacy. Due to shared developmental origins, anatomical features, and physiology, assessment of retinal vessel function may serve as an important surrogate outcome measure to study neurovascular dysfunction. The present study was designed to compare NVC responses in young ( 65 years of age; n = 11) healthy human subjects by assessing flicker light-induced changes in the diameter of retinal arterioles using a dynamic vessel analyzer (DVA)-based approach. We found that NVC responses in retinal arterioles were significantly decreased in older adults as compared with younger subjects. We propose that the DVA-based approach can be used to assess NVC, as a surrogate cerebromicrovascular outcome measure, to evaluate the effects of therapeutic interventions in older individuals.

PurposeTo analyze the effect of the accommodation on the anterior segment data (corneal and anterior chamber parameters) induced by short-time reading in a healthy, nonpresbyopic adult patient group.MethodsImages of both eyes of nonpresbyopic volunteers were captured with a Scheimpflug device (Pentacam HR) in a nonaccommodative state. Fifteen minutes of reading followed and through fixation of the built-in target of Pentacam HR further accommodation was achieved and new images were captured by the device. Anterior segment parameters were observed and the differences were analyzed.ResultsFifty-two healthy eyes of 26 subjects (range 20.04-28.58 years) were analyzed. No significant differences were observed in the keratometric values before and after the accommodative task (p = 0.35). A statistically significant difference was measured in the 5.0-mm-diameter and the 7.0-mm-diameter corneal volume (p = 0.01 and p = 0.03) between accommodation states. Corneal aberrometric data did not change significantly during short-term accommodation. Significant differences were observed between nonaccommodative and accommodative states of the eyes for all measured anterior chamber parameters.ConclusionsAmong the parameters of the cornea, only corneal volume changed during the short-term accommodation process, showing some fine changes with accommodation of the cornea in young, emmetropic patients. The position of the pupil and the anterior chamber parameters were observed to change with accommodation as captured by a Scheimpflug device.

To compare the intraocular pressure (IOP)-lowering efficacy and safety of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) with that of brinzolamide 1% or brimonidine 0.2% monotherapy, all dosed 2 times per day (BID).Six-month, phase 3, randomized, multicenter, double-masked clinical trial.A total of 560 patients with primary open-angle glaucoma or ocular hypertension who had insufficient IOP reduction with their current therapeutic regimen or who were receiving ≥ 2 IOP-lowering medications.Patients received BBFC (n = 193), brinzolamide 1% (n = 192), or brimonidine 0.2% (n = 175) BID.The primary end point was mean change in diurnal IOP from baseline to month 3. Supportive end points included mean diurnal IOP change from baseline at week 2, week 6, and month 6; and mean IOP, mean IOP change from baseline, mean percentage IOP change from baseline, and percentage of patients with IOP18 mmHg at week 2, week 6, month 3, and month 6 at each assessment time point (i.e., 9 am, 11 am, and 4 pm). Adverse events were recorded throughout the study.Baseline diurnal IOP was similar among groups (mean ± standard deviation: BBFC, 25.9 ± 0.19 mmHg; brinzolamide, 25.9 ± 0.20 mmHg; brimonidine, 26.0 ± 0.19 mmHg). At month 3, BBFC lowered mean diurnal IOP from baseline to a significantly greater extent than brinzolamide (least squares [LS] mean difference: -1.4 mmHg; P0.0001; t test) and brimonidine (LS mean difference: -1.5 mmHg; P0.0001). All supportive end points corroborated the results of the primary efficacy analysis. Mean percentage reductions in IOP from baseline were 26.7% to 36.0% with BBFC, 22.4% to 27.9% with brinzolamide, and 20.6% to 31.3% with brimonidine. The most common adverse drug reactions were ocular side effects, including hyperemia, blurred vision, allergic-type reactions, and discomfort. The incidence of hyperemia of the eye was slightly lower with brinzolamide than with BBFC and brimonidine, whereas blurred vision and ocular discomfort were slightly more common with BBFC than with brinzolamide or brimonidine.Brinzolamide 1% and brimonidine 0.2% fixed combination administered BID had a significantly greater IOP-lowering effect than either brinzolamide or brimonidine alone and displayed a safety profile consistent with its individual components.

Cataractsurgeryhaschangedfundamentallybytheintroductionofphacoemulsification,which hasbecomenowadaysthestandardmethodtoremovecataracts.Theself-sealingwoundissmaller,postoperativeastigmatismisless,andtheopticalrehabilitationissignificantlyquickerduring theprocedurecomparedtomanualextracapsularcataractextraction.Mostlensnucleimustbe divided first, after which they can be safely removed during surgery. Many complications may occurduringstandardphacoemulsificationusingtraditionalultrasound.Oneofthemostimpor tantcomplicationsisdamagingtheendothelium,whichmayleadtocornealdecompensationif thedeteriorationisserious. Asaresultofprogressinophthalmology,thekineticenergyofthefluidhasbecomeusablein cataractsurgery.Inrecentyears,oneofthemostmeaningfultechnicalinnovationswastheintro ductionofAqualase.Duringthisprocedure,shortpulsesofwarmedbalancedsaltsolutionlique fythelensmaterial.Advantagesofthemethodarethatthereisnoultrasoundandheatingeffect during the procedure, the Aqualase handpiece is more capsule-friendly than the ultrasound handpiece,andpolishingtheposteriorcapsuleispossiblewiththepulses.Theonlyreportedlim itationofthefluid-basedsystemisthatitisnotaseffectiveinhardcataractsastheconventional ultrasoundtechnique.Theinvivo effectofAqualaseonthecornealendotheliumwasunknown atthebeginningofourstudy. After removing nucleus and cortex, a foldable posterior chamber intraocular lens (IOL) is implanted to secure optical rehabilitation to the patient. In recent years, monofocal IOLs are commonlyusedallovertheworld,whichusuallyprovideperfectuncorrecteddistancevisualacu ityforthepatients,butnearvisionisrarelysufficientwithoutcorrection.Itisknownthatsome pseudophakicpatientswithmonofocalIOLshavegoodnearvisualacuitywiththeirdistancecor rection.Thisphenomenoniscalledpseudoaccommodationorapparentaccommodation,which

To evaluate anterior segment alterations with age and during accommodation in different age groups.Department of Ophthalmology, Medical and Health Science Center, University of Debrecen, Debrecen, Hungary.Fifty-three subjects (101 normal eyes) were enrolled in this study and divided into 3 age groups: younger than 30 years (Group 1), between 31 years and 44 years (Group 2), and older than 45 years (Group 3). The total amplitude of accommodation was determined with a defocusing technique, and anterior segment measurements were performed by partial coherence interferometry.Group 1 comprised 32 eyes; Group 2, 37 eyes; and Group 3, 32 eyes. The total amplitude of accommodation decreased with age (P.0001). With the target position at infinity, the lens thickness (LT) and anterior segment length (ASL) increased and the anterior chamber depth (ACD) decreased significantly with age (P.0001). During accommodation in the youngest group, the mean change in LT was 36.3 mum/diopter (D) and in ACD, -26.7 mum/D. The mean accommodation-induced ACD change was -0.08 mm +/- 0.06 (SD) in Group 1, -0.064 +/- 0.087 mm in Group 2, and -0.03 +/- 0.06 mm in Group 3 (P = .0004). The mean LT change during near fixation was 0.109 +/- 0.063 mm in Group 1, 0.103 +/- 0.136 mm in Group 2, and 0.006 +/- 0.05 mm in Group 3 (P.0001). The mean ASL change during accommodation was 0.029 +/- 0.037 mm, 0.039 +/- 0.114 mm, and -0.023 +/- 0.051, respectively (P.0001).In addition to forward movement of the anterior lens surface with age, the posterior surface moved backward. Alterations in LT and ACD sufficient for a unit of refractive power change during accommodation might be smaller than previously thought. Anterior shifting of the lens may also participate in the accommodative response.

To compare the accommodative amplitudes with three different methods in pseudophakic eyes with different types of intraocular lenses (IOLs).Fifty-one pseudophakic eyes of 44 patients (age: 72.02+/-8.53 years) were studied. One of two different types of IOL were implanted (N=30, three-piece Alcon Acrysof MA60AC and N=21, one-piece Alcon Acrysof SA60AT) in-the-bag after standard phacoemulsification. The time of the examinations was 13.85+/-7.35 months postoperatively. We measured the amplitude of accommodation with three different methods: (1) subjective minus-lenses-to-blur method; (2) a new optical device (ACMaster, Carl Zeiss, Jena, Germany) using partial coherence interference (PCI) technique under physiological stimulus; and (3) objective anterior chamber depth measuring with a standard A-scan ultrasonic device (Ultrascan Imaging System, Alcon Laboratories, Forth Worth, TX, USA) before and after pharmacological relaxation of ciliary muscle.We measured -0.83+/-0.63 D amplitude of accommodation with subjective minus-lenses-to-blur method. The IOL position did not change significantly during physiological accommodation effort measured with PCI method (-0.026+/-0.134 mm). The change in the IOLs position between near fixating and after ciliary muscle relaxation was -0.18+/-0.28 mm measured with ultrasound. There were no significant differences between values of one-piece and three-piece IOL groups.The amplitude of accommodation measured by subjective and objective methods are different and are not comparable with each other. We did not observe any difference between values of examined two types of IOLs.

Megfigyelhető, hogy egyes betegek a szürkehályog-műtét során beültetett monofokális műlencse implantálása után, távoli korrekció mellett is jól használható közeli látásélességet érnek el. Ezt a jelenséget nevezik pszeudoakkomodációnak, aminek megértése és mérése a pseudophakiás szemek akkomodációjának új technikákkal történő pótlása, illetve helyreállítása miatt elengedhetetlen. Célkitűzés: I. A szürkehályog-műtét után megfigyelhető akkomodáció mérése. II. A csarnokmélység mérése Scheimpflug-képalkotással, és az eredmények összehasonlítása a standard, ultrahangos módszerrel. III. Egy új optikai eszköz, az elülső szegmentum optikai koherenciatomográf (Visante OCT) elülsőcsarnok-mélység mérésének eredményeit, illetve annak ismételhetőségét és megbízhatóságát vizsgálni immerziós ultrahangos módszerrel összehasonlítva, phakiás szemeken. Módszer: I. Az akkomodációt defokuszáló módszerrel, parciális koherencia-interferometria módszerével és a szem elülsőcsarnok-mélysége változásának a musculus ciliaris farmakológiai befolyásolása során mértük. II. A szem elülső csarnokának mélységét Pentacammal mértük, és az eredményeket összehasonlítottuk a standard ultrahangos módszerrel phakiás és pseudophakiás szemeken. III. Két vizsgáló mérési eredményeit és azok ismételhetőségét vetettük össze Visante OCT-vel történő elülsőcsarnok-mélység mérése után. Eredmények: I. A defokuszáló technikával 0,83 D-ás teljes akkomodációs amplitúdót igazoltunk. Parciális koherencia-interferometria módszerével a műlencsék elmozdulása fiziológiás akkomodációs inger mellett minimális volt. A musculus ciliaris farmakológiai bénítása során a műlencse átlagosan 0,18 mm-t mozdult előre. II. Phakiás szemeken a Pentacam és ultrahangos módszer eredményei azonosak, pseudophakiás szemeken azonban az optikai módszer lényegesen kisebb csarnokmélységet mér. III. Elülső szegmentum optikai koherenciatomográf az immerziós ultrahangos eszköznél nagyobb csarnokmélységet mér phakiás szemeken. Következtetések: A pseudophakiás szemeken megfigyelhető akkomodációs amplitúdó hátterében álló akkomodáció, illetve pszeudoakkomodáció mérése igen bonyolult, és a különböző módszerekkel csak egy-egy részfolyamat mérhető. A nem kontakt optikai módszerekkel a standard ultrahangos módszerhez képest jelentősen eltérő csarnokmélységek mérhetők. Az elülsőcsarnok-mélység mérésének intra- és interobserver ismételhetősége, valamint megbízhatósága az optikai eszközzel lényegesen jobb.

Purpose To measure anterior chamber depth (ACD) with an anterior segment optical coherence tomography (AS-OCT) and a standard ultrasonic (US) axial scan (A-scan) device using an immersion technique and to assess repeatability, reproducibility, and correlations of the measurements. Setting Department of Ophthalmology, Medical Health and Science Center, University of Debrecen, Debrecen, Hungary. Methods Sixty healthy eyes of 41 patients were enrolled in a study. The central ACD was measured 5 times with AS-OCT (Visante, Carl Zeiss Meditec) using its chamber tool and 5 times with a US A-scan device (UltraScan Imaging System, Alcon Laboratories) using an immersion method. The measurements were performed consecutively by 2 independent observers. Results The mean ACD measured with AS-OCT was 3.12 mm ± 0.33 (SD) by observer 1 and 3.11 ± 0.33 mm by observer 2 ( P = .78). The repeatability was 0.8% ± 0.4% and 1.9% ± 1.4%, respectively. The reproducibility was 0.23%. The reliability coefficient with AS-OCT was 99.6%. The mean ACD measured with immersion US A-scan was 2.98 ± 0.33 mm by observer 1 and 2.95 ± 0.34 mm by observer 2 ( P = .68) . The repeatability was 6.4% ± 3.8% by observer 1 and 8.5% ± 4.9% by observer 2. The reproducibility was 0.88%. The reliability coefficient was 87.1% for US A-scan measurements. The difference between ACD values with AS-OCT and values with US A-scan was statistically significant ( P = .02). The correlation ( r ) between AS-OCT and US A-scan was 0.732 ( P P Conclusions Anterior chamber measurements were significantly deeper with AS-OCT than with US immersion A-scan. Repeatability of ACD measurements was better with AS-OCT than with immersion US, and reproducibility was equal with the 2 methods.

Purpose To understand the source and evolution of the cellular elements of posterior capsule plaques. Setting Department of Ophthalmology, University of Sciences, Faculty of Medicine, Pecs, Hungary. Methods In 24 eyes of 24 patients, the primary fibrotic plaques were carefully peeled off the posterior capsule with forceps and sent for histological examination. The samples were stained with hematoxylin-eosin and with picrosirius to demonstrate collagen content. Results Most plaques were found in elderly patients with mature cataracts. However, one was found in a patient with congenital cataract. The histological examination revealed different stages of plaques, permitting discrimination of early (cellular), transitional, and late (fibrotic) stages. The plaques in the early stage contained cuboidal cells with nuclei; collagen deposition led to the development of the transitional stage; and further collagen deposition led to the fibrotic stage. There was no significant correlation between the maturity of the cataract and the plaque stage, but other factors such as previous eye surgery (vitrectomy, glaucoma surgery), long-standing diabetes mellitus (DM), and a high degree of myopia appeared to contribute to the development of plaques. Conclusions Primary posterior capsule plaques were found primarily in elderly patients with mature cataracts but were also present post vitrectomy in those who had DM from a young age and had early stages of cataract. In the early plaque stage, cells with nuclei were found. It follows that plaques are capable of proliferation at this stage, aggravating visual disturbance. Therefore, removing the plaques by peeling from the posterior capsule or by posterior capsulorhexis during surgery is suggested.

To quantitatively assess corneal endothelial changes after phacoemulsification with the fluid-based system compared to conventional ultrasound technique.This prospective, randomized clinical study included patients with cataract who were randomly assigned either to have phacoemulsification with the fluid-based system (30 eyes of 30 patients--Group 1) or with traditional ultrasound (30 eyes of 30 patients--Group 2). Patients who were available at each follow-up visit (25 eyes in both groups) were enrolled in the statistical analysis. Endothelial function was evaluated by measuring central corneal thickness, central endothelial cell density (ECD), mean cell size, and coefficient of variation in cell size preoperatively, 10 days, 1 and 3 months, and 1 year after surgery. Statistical analyses were performed using two-way repeated measure ANOVA.An acute, reversible increase of central corneal thickness (CCT) was found 10 days after surgery, which was similar in both groups (P=0.35). ECD decreased, whereas mean cell size increased significantly immediately after surgery. However, the impairments were finished after 1 month. The alterations were similar in both groups (ECD: P=0.99; mean cell size: P=0.85). The coefficient of variation in cell size remained stable after surgery (P=0.08), and significant difference was not found between groups (P=0.99). The endothelial cell loss (ECL) was 6.5+/-8.4% in Group 1 and 6.5+/-11.7% in Group 2 (P=0.69).Corneal endothelial changes were similar using the fluid-based system compared to the traditional ultrasound technique. The fluid-based method proved to be as safe as conventional ultrasound in cataract surgery.

To distinguish pseudophakic accommodation from pseudoaccommodation by measuring the physiologically and pharmacologically induced anterior chamber depth (ACD) shifts.Department of Ophthalmology, University of Debrecen, Debrecen, Hungary.This study comprised 100 pseudophakic eyes of 79 patients. Forty patients (Group 1) received the AcrySof MA60AC intraocular lens (IOL) (Alcon Laboratories), 50 patients (Group 2) received the SA60AT IOL (Alcon Laboratories), and 10 patients (Group 3) received the apodized diffractive SA60D3 ReSTOR IOL. Visual function was evaluated a mean of 10.2 months +/- 9.2 (SD) postoperatively, and the total pseudoaccommodative amplitude was determined with a defocusing technique. To distinguish pseudophakic accommodation from pseudoaccommodation, ACD measurements were performed using partial coherence interferometry during distance fixation and physiologic accommodation after pharmacologic relaxation of the ciliary muscle.Best corrected distance and near visual acuities were similar in the 3 groups (P = .75 and P = .08, respectively). Distance corrected near visual acuity was significantly better in Group 3 (P.001), with all eyes achieving J1 or better. Three percent in Group 1 and 8% in Group 2 achieved J1 or better. Subjective accommodation was similar in Groups 1 and 2 (-0.82 +/- 0.18 diopter [D] and -1.00 +/- 0.35 D, respectively; P = .3). Group 3 had an accommodation curve with 2 peaks. Intraocular lens movement differences between the groups were not significant (physiologic stimulus: P = .07; cyclopentolate: P = .46), and significant ACD shifts from baseline were not detected (physiologic stimulus: P = .14; cyclopentolate: P = .10).Pseudoaccommodative amplitude of the investigated monofocal IOLs was independent of IOL movement. Anterior shift did not affect good near visual acuity with the AcrySof ReSTOR IOL.

Purpose To compare central corneal thickness (CCT) values obtained with ultrasonic pachymetry and a new optical method using partial coherence interferometry (PCI). Setting Department of Ophthalmology, Medical Health and Science Center, University of Debrecen, Debrecen, Hungary. Methods The study comprised 136 eyes of 70 patients whose spherical refractive error was not greater than ±6.0 diopters (D) and whose keratometric astigmatism was not greater than 2.0 D. Central corneal thickness was measured 5 times with a new optical device (ACMaster, Zeiss) and with an ultrasonic pachymeter (AL-2000, Tomey). All measurements were obtained by the same investigator. Results Mean CCT was 531.2 μm ± 3.9 (SD) with PCI and 547.8 ± 36.0 μm with the ultrasonic device. The difference between groups was significant (P = .001). There was no difference between CCT values measured in right and left eyes (P = .55) with ultrasonography and PCI (P = .67). The coefficient variation was 0.73% for PCI and 6.5% for ultrasonography. Correlation between the CCT measurements with both devices was strong and statistically significant (Spearman correlation = .91, P = .001). Conclusions Mean CCT values measured by the PCI method were significantly smaller than those measured by the ultrasonic device. Central corneal thickness measured with PCI is more reproducible and seems to be more reliable than that measured by ultrasonography.

To determine whether, similar to ultrasound phaco-emulsification, applied energy and surgery time decrease using phaco-chop nucleus fragmentation method compared to divide and conquer technique using the fluid-based system.This prospective, comparative, randomized clinical study included patients with cataract who were randomly assigned to use either standard divide and conquer technique (25 eyes of 25 patients, Group 1) or Nagahara phaco-chop maneuver (25 eyes of 25 patients, Group 2) during fluid-based phaco-emulsification. Surgical parameters were recorded and patients were examined 1 day, 10 days, and 1 month after surgery. Statistical analyses were performed using the paired test of Wilcoxon.Fluid-based time, mean fluid-based magnitude, effective fluid-based time, and the number of pulses were significantly less using phaco-chop technique compared to divide and conquer method (p0.001). Surgery time was similar using the two nucleofractis techniques (p=0.97). Visual acuities showed no statistical differences between the two groups (p0.05).Nuclear fragmentation can be performed with Nagahara phaco-chop technique using the fluid-based system as well. The applied fluid-based energy decreases compared to divide and conquer method. However, surgery time is not reduced due to the difficulties reaching the full occlusion necessary to hold the nucleus during the chop maneuver.