Retina as a potential biomarker in schizophrenia spectrum disorders: a systematic review and meta-analysis of optical coherence tomography and electroretinography.

INTRODUCTION: Abnormal findings on optical coherence tomography (OCT) and electroretinography (ERG) have been reported in participants with schizophrenia spectrum disorders (SSDs). This study aims to reveal the pooled standard mean difference (SMD) in retinal parameters on OCT and ERG among participants with SSDs and healthy controls and their association with demographic characteristics, clinical symptoms, smoking, diabetes mellitus, and hypertension. METHODS: Using PubMed, Scopus, Web of Science, and PSYNDEX, we searched the literature from inception to March 31, 2023, using specific search terms. This study was registered with PROSPERO (CRD4202235795) and conducted according to PRISMA 2020. RESULTS: We included 65 studies in the systematic review and 44 in the meta-analysis. Participants with SSDs showed thinning of the peripapillary retinal nerve fiber layer (pRNFL), macular ganglion cell layer- inner plexiform cell layer, and retinal thickness in all other segments of the macula. A meta-analysis of studies that excluded SSD participants with diabetes and hypertension showed no change in results, except for pRNFL inferior and nasal thickness. Furthermore, a significant difference was found in the pooled SMD of pRNFL temporal thickness between the left and right eyes. Meta-regression analysis revealed an association between retinal thinning and duration of illness, positive and negative symptoms. In OCT angiography, no differences were found in the foveal avascular zone and superficial layer foveal vessel density between SSD participants and controls. In flash ERG, the meta-analysis showed reduced amplitude of both a- and b-waves under photopic and scotopic conditions in SSD participants. Furthermore, the latency of photopic a-wave was significantly shorter in SSD participants in comparison with HCs. DISCUSSION: Considering the prior report of retinal thinning in unaffected first-degree relatives and the results of the meta-analysis, the findings suggest that retinal changes in SSDs have both trait and state aspects. Future longitudinal multimodal retinal imaging studies are needed to clarify the pathophysiological mechanisms of these changes and to clarify their utility in individual patient monitoring efforts.

Opposite effects of smoking and nicotine intake on cognition.

Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.

Structural imaging of the retina in psychosis spectrum disorders: current status and perspectives.

PURPOSE OF REVIEW: Structural changes of the retina in schizophrenia and other psychotic disorders seem plausible as these conditions are accompanied by widespread morphological abnormalities of the brain. Advances in structural retinal imaging have led to the possibility of precise quantification of individual retinal layers, using optical coherence tomography (OCT) scanners. RECENT FINDINGS: The aggregation of information related to OCT findings in schizophrenia has resulted in three metaanalyses, which are currently described. Areas where retinal changes were reported include retinal nerve fiber layer (RNFL), ganglion cell layer complex (GCC), macular volume, and macular thickness, but findings on affected retinal segments vary to some extent across studies. Discrepancies in individual studies could be because of small samples, heterogeneity within schizophrenia (phase of the illness, illness duration, predominant symptomatology), inconsistent reporting of antipsychotic therapy, insufficient control of confounding variables (somatic comorbidities, smoking, and so on), and use of the different types of OCT scanners. SUMMARY: Exploration of potential disturbances in retinal architecture could provide new insights into neuronal changes associated with psychosis spectrum disorders, with potential to elucidate the nature and timing of developmental, progressive, inflammatory, and degenerative aspects of neuropathology and pathophysiology, and to assist with characterizing heterogeneity and facilitating personalized treatment approaches.

Dental Hygienists' and Dentists' Tobacco Cessation Continuing Education Preferences: Application of a Discrete Choice Method.

Despite ample opportunity, dental professionals frequently fall short of connecting tobacco-using patients with effective cessation support, often citing lack of training as a barrier. To inform development of training options, the aim of this study was to quantify the preferences of practicing dental hygienists and dentists in California for continuing dental education (CDE) offerings related to tobacco and patient tobacco cessation. Two statewide surveys of California dental hygienists and dentists were conducted. In addition to providing their own and their practice characteristics, in a discrete choice experiment, participants indicated their preferences between pairs of randomly generated hypothetical tobacco cessation CDE offerings that differed in topic, cost, delivery modality, and duration. Ultimately, 641 dental hygienists (20.5% of the total invited minus those with undeliverable emails, n=3,129) and 654 dentists (8.5% of the total invited minus those with undeliverable emails, n=7,669) responded to at least one of the discrete choice items, and their responses were analyzed. The results showed that each CDE attribute was independently associated with preference. Cost and topic were more strongly associated with preference than were delivery modality and duration. Lower cost, shorter duration courses were generally favored. Alternative tobacco products and patient communication were the most popular topics for participating dental hygienists and dentists, respectively. CDE preferences differed according to participant characteristics: live webinars were the least preferred modality for more experienced dental professionals, and shorter courses were not preferred by dentists in non-urban locations. These findings showed that these dental professionals considered multiple attributes in selecting CDE courses. To reach the broadest audience, CDE providers should offer low-cost options across a range of delivery modalities, such as full-day workshops in rural areas and online webinars for earlier career professionals.

Schizophrenia and the retina: Towards a 2020 perspective.

BACKGROUND: Differences between people with schizophrenia and psychiatrically healthy controls have been consistently demonstrated on measures of retinal function such as electroretinography (ERG), and measures of retinal structure such as optical coherence tomography (OCT). Since our 2015 review of this literature, multiple new studies have been published using these techniques. At the same time, the accumulation of data has highlighted the "fault lines" in these fields, suggesting methodological considerations that need greater attention in future studies. METHODS: We reviewed studies of ERG and OCT in schizophrenia, as well as data from studies whose findings are relevant to interpreting these papers, such as those on effects of the following on ERG and OCT data: comorbid medical conditions that are over-represented in schizophrenia, smoking, antipsychotic medication, substance abuse, sex and gender, obesity, attention, motivation, and influences of brain activity on retinal function. RESULTS: Recent ERG and OCT studies continue to support the hypothesis of retinal structural and functional abnormalities in schizophrenia, and suggest that these are relevant to understanding broader aspects of pathophysiology, neurodevelopment, and neurodegeneration in this disorder. However, there are differences in findings which suggest that the effects of multiple variables on ERG and OCT data need further clarification. CONCLUSIONS: The retina, as the only component of the CNS that can be imaged directly in live humans, has potential to clarify important aspects of schizophrenia. With greater attention to specific methodological issues, the true potential of ERG and OCT as biomarkers for important clinical phenomena in schizophrenia should become apparent.

Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical "Pulse" Dose.

INTRODUCTION: This small pilot study is the first direct comparison of the currently marketed formulations of bromfenac (0.07% solution) and nepafenac (0.3% suspension) using identical dosing regimens and including an extra pre-surgical "pulse" dose in patients undergoing cataract surgery. METHODS: Adults scheduled for unilateral phacoemulsification with intraocular lens implantation were randomly assigned to bromfenac 0.07% or nepafenac 0.3%, each given once-daily 1 day prior to surgery, on the day of surgery plus an extra dose 1 h before surgery, and for 14 days after surgery. Assessments included summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography. RESULTS: The study population included 49 patients (bromfenac, n = 24; nepafenac, n = 25). The percentage of patients with a SOIS = 0 (no cells or flare) at post-surgical day 15 (primary efficacy endpoint) was statistically similar between the bromfenac (57.1%) and nepafenac (50.0%) treatment groups (intent-to-treat with last observation carried forward) (P = 0.6318). The proportions of patients with an SOIS of 0 at days 3 and 8 were significantly (P < 0.05) higher in the bromfenac group (23.8 and 52.4%, respectively) versus the nepafenac group (0.0 and 20.8%, respectively). Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness. Rescue medication (typically difluprednate) was given on or before day 15 to 13 patients in each treatment group (bromfenac, 54.2%; nepafenac, 52.0%). There were no adverse events considered to be related to either treatment. CONCLUSIONS: The results of this small pilot study suggest that once-daily bromfenac 0.07% produces similar benefits with regard to postsurgical inflammation, VA, and retinal thickness as once-daily nepafenac 0.3%, and possibly has a faster onset of anti-inflammatory action, when compared using identical dosing regimens. FUNDING: Bausch & Lomb Incorporated. TRIAL REGISTRATION: NCT03886779.

Visual impairments in tobacco use disorder.

Prior studies found small effects of chronic smoking on spatial and color vision, but they were inconclusive. This study tries to: (1) replicate and extend these previous findings, and (2) rule in that this relationship is pronounced by tobacco addiction. Data were recorded in 71 healthy controls (M = 33.5 years; SD = 5.4 years) and 63 individuals with tobacco addiction (M = 34.7 years; SD = 4.8 years). Visual processing was assessed in the forms of contrast sensitivity for linear sine-wave gratings (spatial frequencies ranging between 0.2 and 16 cycles per degree) and color discrimination (using the Ellipse and Trivector subtests). The groups were matched for age, gender and level of education. The group with heavy smokers had reduced sensitivity for all spatial frequencies (p < .001), and impairments in color discrimination for both Trivector (all p-values < .001 for Protan, Deutan and Tritan) and Ellipse (all p-values < .001). This study consistently replicates and extended previous findings, and showed that visual processing can be strongly associated with tobacco addiction. These results indicate that excessive use of cigarettes, or chronic exposure to their compounds, affects visual discrimination, supporting the existence of overall deficits in visual processing in tobacco addiction.

Psychophysical evaluation of contrast sensitivity using Gabor patches in tobacco addiction.

This study, an extension of Fernandes et al. (2017), provided consistent contrast sensitivity function (CSF) measurements in a large sample. CSF was assessed for luminance stimuli in different 48 chronic smokers and 50 healthy nonsmokers. Stimuli for the CSF were Gabor patches with spatial frequencies of .2, 2.5, 5.0, 10.0, and 20.0 cycles per degree (cpd). The use of Gabor patches minimizes uncertainty in spatial position and detection of frequencies. The Gabor patches consisted of vertical gratings that were multiplied by a two-dimensional spatial Gaussian envelope. All of the groups were matched for gender and level of education. All of the participants were free from any neurological disorder, cardiovascular disease, and identifiable ocular disease, and they had normal or corrected-to-normal visual acuity. No abnormalities were detected on the fundoscopic examination or optical coherence tomographic examination. The smoker group had a lower CSF compared with healthy nonsmokers at all spatial frequencies. These results indicate that cigarette smoking or chronic exposure to its constituent compounds affects early-stage visual discrimination, suggesting the existence of deficits in early visual spatial processing in smokers.

Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome.

PURPOSE: To determine the effect of phenylephrine 1.0%-ketorolac 0.3% injection (Omidria) on different components of intraoperative floppy-iris syndrome (IFIS). SETTING: Silverstein Eye Centers, Kansas City, Missouri, USA. DESIGN: Prospective case series. METHODS: Men treated with tamsulosin having standard cataract extraction surgery were placed in a treatment group that received phenylephrine 1.0%-ketorolac 0.3% injection in the irrigation solution and a control group) that received basic saline solution. Every procedure was video recorded using an endocyclophotocoagulation (ECP) probe and microscopic view. Pupil dilation, iris billowing, and iris prolapse were measured using a micrometer, ECP recording grading scale, and microscopic recordings, respectively. RESULTS: Each group (treatment and control) comprised 25 eyes of 25 patients. Although both groups had a decrease in pupil diameter before and after cataract extraction and before cataract extraction and after intraocular lens implantation, the changes were statistically significantly greater in the treatment group. Iris prolapse occurred in 3 patients (12.0%) in the treatment group and 14 patients (56.0%) in the control group (P < .001). Stage 3 (severe) pupil billowing occurred in 1 eye (4.0%) in the treatment group and 10 eyes (40.0%) in the control group (P < .001). CONCLUSIONS: The use of the phenylephrine 1.0%-ketorolac 0.3% injection combination added to the irrigating solution during cataract surgery in patients at risk for IFIS led to significantly better prevention of miosis, less pupil billowing, and a reduced incidence of iris prolapse. A new grading scale for intraoperative iris abnormalities might be used for future evaluation.

An update on the Society for Immunotherapy of Cancer consensus statement on tumor immunotherapy for the treatment of cutaneous melanoma: version 2.0.

BACKGROUND: Cancer immunotherapy has been firmly established as a standard of care for patients with advanced and metastatic melanoma. Therapeutic outcomes in clinical trials have resulted in the approval of 11 new drugs and/or combination regimens for patients with melanoma. However, prospective data to support evidence-based clinical decisions with respect to the optimal schedule and sequencing of immunotherapy and targeted agents, how best to manage emerging toxicities and when to stop treatment are not yet available. METHODS: To address this knowledge gap, the Society for Immunotherapy of Cancer (SITC) Melanoma Task Force developed a process for consensus recommendations for physicians treating patients with melanoma integrating evidence-based data, where available, with best expert consensus opinion. The initial consensus statement was published in 2013, and version 2.0 of this report is an update based on a recent meeting of the Task Force and extensive subsequent discussions on new agents, contemporary peer-reviewed literature and emerging clinical data. The Academy of Medicine (formerly Institute of Medicine) clinical practice guidelines were used as a basis for consensus development with an updated literature search for important studies published between 1992 and 2017 and supplemented, as appropriate, by recommendations from Task Force participants. RESULTS: The Task Force considered patients with stage II-IV melanoma and here provide consensus recommendations for how they would incorporate the many immunotherapy options into clinical pathways for patients with cutaneous melanoma. CONCLUSION: These clinical guidleines provide physicians and healthcare providers with consensus recommendations for managing melanoma patients electing treatment with tumor immunotherapy.

Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza™): results of a qualitative survey.

PURPOSE: The purpose of this study is to evaluate the patient experience of sustained release dexamethasone intracanalicular insert (Dextenza™) following cataract surgery as part of a Phase III clinical trial program. METHODS: This cross-sectional, qualitative evaluation involved individual interviews lasting approximately 45 minutes. Patients from four US investigational study sites who had previously received an insert were enrolled. There were no predesignated end points; this was a qualitative survey seeking a deeper understanding of patient experience. RESULTS: Twenty-five patients were interviewed. Most patients (92%) reported the highest level of satisfaction grade with regard to overall product satisfaction. All patients described the insert as comfortable. Most patients (96%) described their overall experience with the insert as very convenient or extremely convenient. Twenty-two of 23 (96%) participants rated their experience with the insert as "very" or "extremely convenient", compared to previous topical therapy, and 88% of patients stated that if they were to undergo cataract surgery again, they would request the insert. When asked if they would recommend the insert to family members or friends, 92% stated they would. The survey found that 84% of participants would be willing to pay more for the insert than for eye drop therapy. CONCLUSION: The dexamethasone insert was found by patients to be highly favorable with regard to overall satisfaction, convenience, and comfort. The insert was well received and largely preferred over topical therapy alternatives following surgery. More extensive evaluation of the patient experience is warranted, and future studies should help inform design of the next generation of sustained release drug delivery systems.

Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens.

PURPOSE: To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL. SETTING: Fifteen sites in the United States. DESIGN: Prospective randomized patient- and observer-masked clinical trial. METHODS: Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire. RESULTS: The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, -0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision. CONCLUSIONS: The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups.

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery.

PURPOSE: To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0-5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation. METHODS: The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day -1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores). RESULTS: The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). CONCLUSION: Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures.

Say what? Integrating hearing into an ophthalmology practice.

More people experience hearing loss than any other undiagnosed medical problem. Vision and hearing are our two most important senses. Your patients must see and hear sufficiently to maximize their quality of life; it makes sense to treat them together. This hearing testing program is part of your ophthalmology practice; effectively administering the program and delivering the message is what works. The patients are already in your office, i.e., same age demographic as for hearing loss. They and their family wish their ophthalmologist had a program to address their hearing related needs. They trust their ophthalmic physician. They know that they receive quality care.

Dentists' attitudes, behaviors, and barriers related to tobacco-use cessation in the dental setting.

OBJECTIVE: This study assessed attitudes, behaviors, and barriers among general dentists in California, Pennsylvania, and West Virginia, related to patient tobacco cessation counseling. METHODS: From 2004 to 2008, a baseline survey was mailed to 271 study dentists randomly selected from a master Delta Dental Insurance Company provider list in each state who had agreed to participate in a tobacco cessation randomized clinical trial. Four backward logistic regression models assessed correlates of the five As related to tobacco cessation: Asking about tobacco use, Advising users to quit, Assessing readiness to quit, Assisting with quitting, and Arranging follow-up. RESULTS: Most respondents (n=265) were male, had practiced dentistry for over 15 years, asked about tobacco use (74%), and advised tobacco users to quit (78%). Only 19% assessed readiness to quit; 39% assisted with quitting; 4% arranged follow-up; and 42% had formal training in tobacco cessation. Believing that tobacco cessation counseling was an important professional responsibility, practicing <15 years, and asking about tobacco use significantly related to advising users to quit. Providing cessation advice and feeling effective intervening related to assessing readiness to quit. Advising users to quit, assessing readiness to quit, feeling effective intervening, and having had formal tobacco cessation training related to assisting with quitting. Barriers to cessation counseling were perceived patient resistance (66%), lack of insurance reimbursement (56%), not knowing where to refer (49%), and lack of time (32%). CONCLUSION: Study dentists reported not fully performing the five As. Advising, assessing, having formal training, and feeling effective increased the likelihood of cessation counseling.

The effect of training on the use of tobacco-use cessation guidelines in dental settings.

BACKGROUND: An increase in the number of dentists conducting tobacco-use cessation treatment is needed. The authors assessed the effects of high-intensity training (HIT) or low-intensity training (LIT) and reimbursement on general dentists' tobacco-use-related attitudes and treatment behaviors. METHODS: The authors randomly selected 265 dentists in three states and assigned them to one of five groups: HIT workshop groups with and without tobacco-use cessation counseling reimbursement, LIT mailed self-study groups with and without reimbursement or a control group. Outcomes at follow-up were dentists' self-reported tobacco-use-related attitudes and behaviors and patients' reports of dentists' behaviors. RESULTS: Significantly more dentists in the intervention groups reported having positive attitudes and behaviors at follow-up than did dentists in the control group. Dentists in the HIT groups, however, reported assessing patients' willingness to quit and assisting them with the quitting process significantly more often than did dentists in the LIT groups. Significantly more patients of dentists in the intervention groups who used tobacco reported receiving advice and assistance from their dentists than did patients of dentists in the control group. Adding reimbursement to HIT or LIT conditions did not provide additional intervention effect. CONCLUSION: Dentists trained by means of a workshop or self-study program used components of a recommended guideline more frequently and felt more positive toward tobacco-use cessation counseling than did dentists in the control group. CLINICAL IMPLICATIONS: Although the workshop training was more successful than the self-study training, the latter's reach among dentists could have a more significant public health impact. The effect of reimbursement needs further study.

Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain.

OBJECTIVE: To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% dosed once daily for the treatment of ocular inflammation and pain following cataract extraction with posterior chamber intraocular lens implantation. METHODS: A total of 455 subjects (455 study eyes: 230 bromfenac, 225 placebo) were enrolled in two randomized double-masked, placebo-controlled, clinical trials at 64 ophthalmology clinics in the United States. Subjects were randomized to receive either bromfenac 0.09% or placebo dosed once daily. Dosing began 1 day before cataract surgery (Day -1), continued on day of surgery (Day 0), and for 14 days following surgery. Evaluations were completed on Days 1, 3, 8, 15 and 22. The primary efficacy endpoint was cleared summed ocular inflammation score (SOIS) by Day 15. The secondary efficacy endpoint was the number of subjects who were pain-free at Day 1. RESULTS: The bromfenac 0.09% group was significantly higher compared to the placebo group in the primary endpoint of the proportion of subjects who had cleared ocular inflammation by Day 15 (P < 0.0001). The mean SOIS for the bromfenac 0.09% group was lower than the placebo group at Days 3, 8, 15, and 22 (P < 0.0001). More bromfenac 0.09% subjects were pain free at Days 1, 3, 8, and 15 (P < 0.0001). Fewer subjects in the bromfenac 0.09% group withdrew from the clinical trials due to lack of efficacy at Day 15 (P < 0.0001). Fewer adverse events were reported in the bromfenac 0.09% group than the placebo group. Limitations included advanced age, female predominance, and surgical nuances among cataract surgeons, making cross-trial comparisons difficult. CONCLUSIONS: Bromfenac ophthalmic solution 0.09% dosed once daily is clinically safe and effective for the treatment of ocular inflammation and the reduction of ocular pain associated with cataract surgery.

Conjunctival concentrations of a new ophthalmic solution formulation of moxifloxacin 0.5% in cataract surgery patients.

PURPOSE: To compare the conjunctival concentrations of moxifloxacin after instillation of a single drop of moxifloxacin ophthalmic solution, 0.5% (Moxi) or a new 0.5% ophthalmic solution formulation (MAF) containing a retention-enhancing agent in patients undergoing cataract surgery. METHODS: This was a randomized, double-masked, parallel-group study. One hundred thirty patients scheduled for routine phacoemulsification and intraocular lens implantation were randomized to both treatment and post-dose sample collection time points. A single topical drop of Moxi or MAF was instilled in the study eye. At the designated time (0.25, 0.5, 1, 3, or 5 h post-dose), 2 conjunctival biopsy samples were obtained (N = 11-13 per treatment condition). Concentrations of moxifloxacin were determined using a validated ultra-performance liquid chromatography method. Moxifloxacin exposure [maximum mean moxifloxacin concentrations (C(max)) and area under the concentration-time curve (AUC)] was estimated from the observed concentration-time data. RESULTS: The conjunctival moxifloxacin C(max), 43.8 µg/g, for MAF was achieved at 0.25 h. This was 1.8-fold higher than the C(max) for Moxi (24.1 µg/g), which was reached at 0.5 h post-dose. MAF AUC(0-3) was significantly greater than the AUC(0-3) of Moxi [50.5 (µg·h)/g vs. 27.1 (µg·h)/g; P < 0.05]. The conjunctival moxifloxacin C(max) for MAF was 337- to 730-fold greater than the reported minimum inhibitory concentration (MIC(90)) values for Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae. The C(max):MIC(90) ratios for Moxi ranged from 185 to 402. Conjunctival AUC(0-24):MIC(90) ratios ranged from 777 to 1,683 for MAF and from 625 to 1,355 for Moxi. CONCLUSIONS: The new MAF ophthalmic formulation of moxifloxacin provided higher peak levels of moxifloxacin in the conjunctiva tissue, and larger total tissue exposure than the current, commercially available formulation. The superior penetration of MAF observed in this study could translate into greater eradication of bacteria.

Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.

PURPOSE: To assess the efficacy and safety of difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery. SETTING: Twenty-six clinics in the United States. METHODS: One day after unilateral ocular surgery, patients who had an anterior chamber cell grade of 2 or higher (>10 cells) were treated with 1 drop of difluprednate 2 times or 4 times a day or with a placebo (vehicle) 2 times or 4 times a day in the study eye for 14 days. This was followed by a 14-day tapering period and a 7-day safety evaluation. Outcome measures included cleared anterior chamber inflammation (grade 0, or=10 mm Hg and >or=21 mm Hg from baseline, respectively) versus 1% in the placebo group. CONCLUSIONS: Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively. There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group.