Reduced Posology of an Ophthalmic Hydrogel Containing Dexamethasone/Netilmicin to Prevent and Treat Ocular Inflammation After Cataract Surgery: Efficacy and Tolerability.

INTRODUCTION: To demonstrate efficacy and safety of an ophthalmic hydrogel formulation of netilmicin/dexamethasone, containing xanthan gum twice a day (b.i.d.) versus netilmicin/dexamethasone eye drops four times a day (q.i.d) to treat inflammation and prevention of infection after cataract surgery. METHODS: Patients undergoing phacoemulsification with intraocular lens implantation (IOL) were randomised in two groups: group 1, twice daily (b.i.d.) dexamethasone 0.1%/netilmicin 0.3% (Netildex) ophthalmic gel; group 2, four times daily (q.i.d.) dexamethasone 0.1%/netilmicin 0.3% (Netildex) eye drops. Both treatments were administered for 14 days after surgery. Patients were evaluated before surgery, on the day of surgery and at 1, 7, 15 and 60 postoperative days. The primary efficacy endpoint was evaluation of cellularity and flare in the anterior chamber through slit-lamp biomicroscopy 7 days after surgery. Secondary endpoints included: presence of signs/symptoms of postoperative ocular inflammation and incidence of infection. RESULTS: One hundred seventy-three patients were randomised and 168 were evaluable. Flare and cellularity were resolved at day 7 in 92.5% of patients and almost completely by day 15. In both intent to treat (ITT) and per-protocol (PP) populations, the efficacy analysis demonstrated that the gel formulation administered twice a day was non-inferior to the eye drops administered four times a day. For ITT analysis, the lower limit of the 97.5% confidence interval (- 0.0535) was greater than the non-inferiority limit of -0.10. For the PP analysis, the lower limit of the 97.5% confidence interval (- 0.0526) was greater than the non-inferiority limit of - 0.10. The patient's global tolerability and reported symptoms were similar between treatment groups. No microbial load and no safety events were observed. CONCLUSIONS: Efficacy of the gel reduced posology (twice a day) is not inferior to four times a day eye drops. Both treatments were well tolerated and efficacious. The new reduced posology hydrogel formulation may improve patient compliance and quality of life. TRIAL REGISTRATION: Eudract: 2016-0021138-63; ClinicalTrial.gov: NCT029738880.

Dysphotopsia and functional quality of vision after implantation of an intraocular lens with a 7.0 mm optic and plate haptic design.

PURPOSE: To determine the impact of an intraocular lens (IOL) with a 7.0 mm optic and plate haptic design on incidence of dysphotopsia and visual functions after cataract surgery. SETTING: Day-care clinic. DESIGN: Prospective monocentric randomized patient-blinded comparative clinical study. METHODS: Following preoperative measurements, patients underwent cataract surgery with implantation of 2 IOL designs-with 7.0 mm optic and plate haptics (Group 1) or with 6.0 mm optic and C-loop haptics (Group 2). In month 1, 3, and 12 follow-ups, patients were examined, answered a questionnaire regarding satisfaction, spectacle dependence, frequency, and extent of positive and negative dysphotopsia, and underwent contrast sensitivity (CS), mesopic vision, and glare sensitivity testing. The data were analyzed as nominal, ordinal, and metric with chi-square, Mann-Whitney U, Wilcoxon, and t tests. RESULTS: Out of a total number of 120 eyes (86 patients), Group 1 comprised 57 eyes (43 patients), Group 2 comprised 63 eyes (43 patients). Corrected distance visual acuity was the same between groups throughout the study. Group 1 showed significantly lower incidence of positive and negative dysphotopsia in month 1 follow-up (P = .021 and .015, respectively) and a higher satisfaction rate in month 3 follow-up (P = .006). Mean CS and mesopic vision with and without glare were the same in both groups. Positive dysphotopsia cases in month 12 follow-up revealed lower photopic CS (P = .005, .036, and 0.047, respectively), longer axial length, and greater preoperative pupil dynamics (P = .04 and .06). CONCLUSIONS: The IOL design with 7.0 mm optic diameter and plate haptics reduced dysphotopsia and provided good visual acuity, CS, mesopic vision with and without glare, and high patient satisfaction.

[Orbital Trauma]. / Trauma der Orbita.

Orbital trauma is a common medical emergency with potentially sight-threatening complications. Due to the confined orbital conditions, any direct injury or space-consuming lesion may cause serious tissue damage. Possible complications are orbital fractures, foreign body injuries, development of orbital compartment syndrome and traumatic optic neuropathy. Clinical signs include periorbital hematoma or emphysema, subconjunctival hemorrhage, proptosis, decreased ocular mobility, decreased vision, increased intraocular pressure and relative afferent pupillary defect. Ophthalmic status and low-dose CT-imaging provide key information regarding the therapeutic decision. Treatment options include surgical exploration, reconstruction or decompression or a conservative approach with anti-inflammatory or anti-glaucomatous medication. Rapid interdisciplinary diagnostics and therapy is critical for early detection and prevention of irreversible functional loss respectively. Considering the frequent association with life-threatening comorbidities diagnosis may be complicated.

Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial.

BACKGROUND: Neuroprotection and promotion of remyelination represent important therapeutic gaps in multiple sclerosis (MS). Acute optic neuritis (ON) is a frequent MS manifestation. Based on the presence and properties of sphingosine-1-phosphate receptors (S1PR) on astrocytes and oligodendrocytes, we hypothesized that remyelination can be enhanced by treatment with fingolimod, a S1PR modulator currently licensed for relapsing-remitting MS. METHODS: MOVING was an investigator-driven, rater-blind, randomized clinical trial. Patients with acute unilateral ON, occurring as a clinically isolated syndrome or MS relapse, were randomized to 6 months of treatment with 0.5 mg oral fingolimod or subcutaneous IFN-ß 1b 250 µg every other day. The change in multifocal visual evoked potential (mfVEP) latency of the qualifying eye was examined as the primary (month 6 vs. baseline) and secondary (months 3, 6 and 12 vs. baseline) outcome. In addition, full field visual evoked potentials, visual acuity, optical coherence tomography as well as clinical relapses and measures of disability, cerebral MRI, and self-reported visual quality of life were obtained for follow-up. The study was halted due to insufficient recruitment (n = 15), and available results are reported. RESULTS: Per protocol analysis of the primary endpoint revealed a significantly larger reduction of mfVEP latency at 6 months compared to baseline with fingolimod treatment (n = 5; median decrease, 15.7 ms) than with IFN-ß 1b treatment (n = 4; median increase, 8.15 ms) (p <  0.001 for interaction). Statistical significance was maintained in the secondary endpoint analysis. Descriptive results are reported for other endpoints. CONCLUSION: Preliminary results of the MOVING trial argue in support of a beneficial effect of fingolimod on optic nerve remyelination when compared to IFN-ß treatment. Interpretation is limited by the small number of complete observations, an unexpected deterioration of the control group and a difference in baseline mfVEP latencies. The findings need to be confirmed in larger studies. TRIAL REGISTRATION: The trial was registered as EUDRA-CT 2011-004787-30 on October 26, 2012 and as NCT01647880 on July 24, 2012.

Visual function and reading speed after bilateral implantation of 2 types of diffractive multifocal intraocular lenses: Add-on versus capsular bag design.

PURPOSE: To compare the functional outcomes of primary implantation of a monofocal intraocular lens (IOL) in the capsular bag and an add-on multifocal IOL in the sulcus with the functional results of a conventional multifocal posterior chamber IOL and to evaluate the multifocal add-on IOL as an effective alternative to a conventional multifocal IOL. SETTING: Ernst von Bergmann Eye Clinic, Potsdam, Germany. DESIGN: Prospective nonrandomized case series. METHODS: Cataract surgery patients were assigned to have bilateral implantation of a monofocal IOL (Aspira-aAY) in the capsular bag followed by a multifocal add-on IOL (Diff-sPB) in the sulcus (Group A) or with a conventional multifocal IOL (Diffractiva-s) in the capsular bag (Group B). The main study outcomes were assessed at the last follow-up visit (6 months postoperatively) and included refraction, intraocular pressure, visual acuity, reading speed, contrast sensitivity, defocus curve, and patient satisfaction. RESULTS: The study comprised 26 patients (52 eyes) Cataract surgery was uneventful in all cases. No severe complications were observed 6 months postoperatively. Visual performance with a multifocal diffractive add-on IOL was equivalent to that achieved with a conventional multifocal diffractive posterior chamber IOL. Similarly, there were no significant differences in patient satisfaction and reading speed for any type of letter size between groups (P > .05). CONCLUSION: Implanting a multifocal add-on IOL in the sulcus in addition to a monofocal IOL in the capsular bag produced outcomes similar to those of single implantation of a standard multifocal IOL in the capsular bag. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Posterior chamber phakic intraocular lens to correct myopia: long-term follow-up.

PURPOSE: To evaluate the long-term safety and efficacy of a refractive phakic intraocular lens (pIOL) (PRL) to correct moderate to high myopia. SETTING: Department of Ophthalmology, University Medicine Charité Berlin, Berlin, Germany. DESIGN: Retrospective cohort study. METHODS: Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, intraocular pressure, endothelial cell loss, and adverse events were evaluated. RESULTS: The study enrolled 53 eyes (mean spherical equivalent [SE] -12.17 diopters [D] ± 4.12 [SD]) of 29 patients. The mean age was 34.6 ± 9.2 years and the mean follow-up, 86 ± 21.2 months. The mean UDVA improved from 1.37 ± 0.28 logMAR preoperatively to 0.14 ± 0.19 logMAR at the last postoperative visit (P<.05). The mean CDVA improved from 0.10 ± 0.18 logMAR to -0.01 ± 0.09 logMAR (P<.05). The overall mean efficacy index and mean safety index were 0.9 and 1.21, respectively, at the last follow-up visit. The mean endothelial cell loss at the last follow-up was 6.4%. The complications were slight posterior chamber (PC) pIOL decentration (5 eyes, 9.4%), severe PC pIOL decentration resulting in pIOL removal (1 eye, 1.8%), glaucoma (4 eyes, 7.5%), clinically significant cortical lens opacification resulting in cataract surgery (4 eyes, 7.5%), clinically asymptomatic anterior subcapsular cataract formation (6 eyes, 11.3%), and retinal detachment (2 eyes, 3.8%). CONCLUSIONS: Posterior chamber phakic pIOL implantation to correct moderate to high myopia provided predictable and stable refractive results but with a high rate of serious complications over the long term. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Specific antibody production in herpes keratitis: intraocular inflammation and corneal neovascularisation as predicting factors.

PURPOSE: The purpose of the study is to investigate whether analysis of specific antibody synthesis can aid the diagnosis of herpes keratitis. METHODS: Aqueous humor was collected from 39 patients with presumed recurrent herpes keratitis, including 23 consulting for keratitis and 16 patients scheduled for penetrating keratoplasty. Local antibody production was ascertained by analysis of paired aqueous humor/serum samples, using a modified micro-ELISA technique. RESULTS: Local production of antibodies was found in 32 patients (82%): anti-herpes simplex virus (HSV) antibodies in 26 (67%) and anti-varicella zoster virus (VZV) antibodies in 11 (28%). Twenty of 23 patients with active keratitis (87%), and 12 of 16 undergoing keratoplasty (75%), tested positive. Five patients had local production of both anti-HSV and anti-VZV antibodies, whereas seven patients tested negative. Local antibody production was significantly associated with intraocular inflammation (P<0.05), corneal neovascularisation (P<0.05), and positive response to anti-viral treatment (P<0.05). No complications were encountered in sampling aqueous humor. CONCLUSIONS: Assessment of local anti-HSV and -VZV antibody production is a safe and reliable diagnostic procedure for recurrent herpes keratitis. It might be particularly helpful in patients presenting with intraocular inflammation and neovascularisation since it discriminates between herpes and non-herpes pathologies and may therefore be useful for preventive and therapeutic strategies.

Cytomegalovirus retinitis in Wegener's granulomatosis: case report and review of the literature.

PURPOSE: To present the first case of cytomegalovirus (CMV) retinitis in a Wegener's granulomatosis patient on systemic cyclosporine A (CsA) therapy. METHODS: A 41-year-old patient was treated with systemic CsA for c-ANCA positive Wegener's granulomatosis. Four weeks later he presented with blurred vision and a retinitis was diagnosed in the right eye. After detection of CMV DNA by polymerase chain reaction (PCR), the patient was treated with intravenous gancyclovir. Due to bone marrow toxicity, systemic antiviral therapy was discontinued and an intravitreal gancyclovir pellet was implanted. RESULTS: The retinitis lesions were scarified under this therapy and the patient's visual function was restored completely. CONCLUSIONS: Cytomegalovirus retinitis can occur under systemic monotherapy with CsA in patients with systemic vasculitis. Intraocular virus DNA detection by PCR is recommended to rule out retinal involvement of the underlying vasculitis in atypical cases and to preserve the patient's visual acuity.

[Evaluation of posterior capsule opacification after implantation of the Akreos Disc and Akreos Fit acrylic intraocular lenses - pilot studies]. / Nachstarentwicklung nach Implantation der Acryl-Intraokularlinsen Akreos Disc und Akreos Fit - Pilotstudien.

In the course of the past few years the incidence of secondary cataract has reduced continually due to advanced surgical technique and better lens material and design. To evaluate the progression of posterior capsule opacification (PCO) and IOL-decentration after implantation of two hydrophilic acrylic intraocular lenses (IOL) we set up two pilot studies at two different ophthalmological surgical centres. After extracapsular cataract extraction 15 patients got the Akreos Disc-IOL (Bausch and Lomb) and 12 patients the Akreos Fit-IOL (Bausch and Lomb) implanted. Examinations were done over a period of 12 months. The protocol included the determination of visual acuity, an examination of the anterior segment, evaluation of IOL-decentration and the scoring of PCO with EPCO 2000 by digital photography of the posterior capsule. All patients showed a well centred IOL and stable visual acuity over 12 months. None had to undergo Nd:YAG-capsulotomy. PCO was low and only slightly progressive over the time period.