Difluprednate for the prevention of ocular inflammation postsurgery: an update

Eric D DonnenfeldOphthalmic Consultants of Long Island, Rockville Centre, NY, USAPurpose: To review the most recent published data regarding the novel potent steroid, difluprednate ophthalmic emulsion, 0.05%.Methods: A comprehensive search of recent published literature including difluprednate was performed. Clinical studies relevant to the characteristics and clinical efficacy of difluprednate in controlling postoperative inflammation were included, and a synopsis of each study was developed.Results: Several recent publications were identified in which difluprednate was shown to be efficacious in the treatment of postoperative inflammation in different clinical settings, including a novel perioperative regimen. Additional literature retrieved from this search included data on the relative potency of difluprednate, potential utility in the posterior segment, as well as the advantages of the emulsion formulation.Conclusion: Difluprednate has been studied extensively and shown in recent literature to be a safe and effective topical anti-inflammatory drug. The proven strength and unique formulation of difluprednate, along with its potent efficacy in treating and preventing inflammation, provides clinicians with a beneficial treatment option.Keywords: corticosteroids, anti-inflammatory, dose uniformity, relative potenc

A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma

PURPOSE: To evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication. PATIENTS AND METHODS: In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. RESULTS: Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001). Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation. CONCLUSION: In a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months

Visual Outcomes, Efficacy, and Surgical Complications Associated with Intracameral Phenylephrine 1.0%/Ketorolac 0.3% Administered During Cataract Surgery

Aim: The purpose of this study was to compare visual outcomes, surgical time, and perioperative surgical complications after intracameral use of either phenylephrine/ketorolac (P/K) or epinephrine (Epi) during cataract surgery.Methods: This was a single-center, retrospective case review of patients undergoing cataract surgery from August to November 2015. Of the 641 eyes of 389 patients who underwent cataract surgery, 260 eyes were administered phenylephrine 1.0%/ketorolac 0.3% and 381 eyes received Epi in the irrigation solution intraoperatively. All patients received a topical nonsteroidal anti-inflammatory drug regimen (bromfenac 0.07%, nepafenac 0.3%, or ketorolac 0.5%) for 3 days before surgery and topical tropicamide 1.0%, cyclopentolate 1.0%, and phenylephrine 2.5% on the day of surgery.Results: Mean length of surgery (LOS) was 15.4±0.6 minutes. Although a positive correlation was noted between patient age and LOS (p\u3c0.001), P/K was associated with a decrease in the LOS, when controlled for age quartiles. A statistically significant lower incidence of complications (1.1%) was observed with P/K use than Epi (4.5%; p=0.018). Among surgeons who used mydriatic-assist devices more frequently, P/K use was associated with a reduction in the use of these devices (p\u3c0.001). When controlling for age quartile, patients of age groups 69–76 and 76–92 years who received P/K had significantly better uncorrected visual acuity at postoperative day 1 than those receiving Epi (p=0.003).Conclusion: Intracameral use of phenylephrine 1.0%/ketorolac 0.3% during cataract surgery may be effective in maintaining mydriasis. It appears to be superior to intracameral Epi at reducing intraoperative and postoperative complications, need for pupillary dilating devices, and surgical time

Topical non-steroidal anti-inflammatory drugs for analgesia in traumatic corneal abrasions

BACKGROUND: Traumatic corneal abrasions are relatively common and there is a lack of consensus about analgesia in their management. It is therefore important to document the clinical efficacy and safety profile of topical ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) in the management of traumatic corneal abrasions. OBJECTIVES: To identify and evaluate all randomised controlled trials (RCTs) comparing the use of topical NSAIDs with placebo or any alternative analgesic interventions in adults with traumatic corneal abrasions (including corneal abrasions arising from foreign body removal), to reduce pain, and its effects on healing time. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 2), MEDLINE Ovid (1946 to 30 March 2017), Embase Ovid (1947 to 30 March 2017), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 30 March 2017), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/); searched 30 March 2017, ZETOC (1993 to 30 March 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 30 March 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 30 March 2017 and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 30 March 2017. We did not use any date or language restrictions in the electronic searches for trials.We checked the reference lists of identified trials to search for further potentially relevant studies. SELECTION CRITERIA: RCTs comparing topical NSAIDs to placebo or any alternative analgesic interventions in adults with traumatic corneal abrasions. DATA COLLECTION AND ANALYSIS: Two review authors independently performed data extraction and assessed risks of bias in the included studies. We rated the certainty of the evidence using GRADE. MAIN RESULTS: We included nine studies that met the inclusion criteria, reporting data on 637 participants.The studies took place in the UK, USA, Israel, Italy, France and Portugal. These studies compared five types of topical NSAIDs (0.1% indomethacin, 0.03% flurbiprofen, 0.5% ketorolac, 1% indomethacin, 0.1% diclofenac) to control (consisting of standard care and in four studies used placebo eye drops). Overall, the studies were at an unclear or high risk of bias (particularly selection and reporting bias). None of the included studies reported the primary outcome measures of this review, namely participant-reported pain intensity reduction of 30% or more or 50% or more at 24 hours. Four trials, that included data on 481 participants receiving NSAIDs or control (placebo/standard care), reported on the use of 'rescue' analgesia at 24 hours as a proxy measure of pain control. Topical NSAIDs were associated with a reduction in the need for oral analgesia compared with control (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.34 to 0.61; low-certainty evidence). Approximately 4 out of 10 people in the control group used rescue analgesia at 24 hours. No data were available on the use of analgesia at 48 or 72 hours.One trial (28 participants) reported on the proportion of abrasions healed after 24 and 48 hours. These outcomes were similar in both arms of the trial. (at 24 hours RR 1.00 (0.81 to 1.23); at 48 hours RR 1.00 (0.88 to 1.14); low-certainty evidence). In the control group nine out of 10 abrasions were healed within 24 hours and all were healed by 48 hours. Complications of corneal abrasions were reported in 6 studies (609 participants) and were infrequently reported (4 complications, 1 in NSAID groups (recurrent corneal erosion) and 3 in control groups (2 recurrent corneal erosions and 1 corneal abscess), very low-certainty evidence). Possible drug-related adverse events (AEs) were reported in two trials (163 participants), with the number of adverse events low (4 AEs, 3 in NSAID group, including discomfort/photophobia on instillation, conjunctival hyperaemia and urticaria, and 1 in the control group, corneal abscess) very low-certainty evidence. AUTHORS' CONCLUSIONS: The findings of the included studies do not provide strong evidence to support the use of topical NSAIDs in traumatic corneal abrasions. This is important, since NSAIDs are associated with a higher cost compared to oral analgesics. None of the trials addressed our primary outcome measure of participant-reported pain intensity reduction of 30% or more or 50% or more at 24 hours

Leadership of education psychological services: fit for purpose?

At a time of great change for educational psychology services in England, this paper reviews current theories of leadership and proposes how an integration of key aspects of these can be applied to support a self review of leadership practice, both by individual leaders and by services. The message from current theory is that in the midst of complexity and rapid change, a primary focus on the head of service is outdated; there should instead be a focus to develop the leadership capacity of the service as a whole. Key constructs considered are systems thinking, social identity, authenticity, and leadership as social construction

Congenital diaphragmatic hernia in a patient with tetrasomy 9p

Tetrasomy of the short arm of chromosome 9 constitutes a rare condition resulting in a well clinically recognized syndrome. In our case, in addition to the characteristic phenotype at birth, the existence of a hernia-type Bochdalek diaphragmatic defect was found. Cytogenetic analysis revealed a nonmosaic case of an isochromosome of the entire short arm of chromosome 9 with no involvement of the heterochromatic region of the long arm: 47, XX, +i (9p). Because chromosome 9 contains several gene locus for enzymes and receptors of the retinoid pathway, this case potentially contributes to retinoid hypothesis in the etiology of congenital diaphragmatic hernia