Purpose: Exploratory analysis associated with the prospective, multicenter, randomized PRIVENT trial. To characterize the associations between laser flare photometry and anatomical and epidemiological features of rhegmatogenous retinal detachment (RRD). Methods: The authors measured laser flare values of all 3,048 prescreened patients excluding those with comorbidities. A mixed regression analysis evaluated the strength of the influencing factors like age, sex, lens status, and presence and extent of RRD on laser flare. Results: Rhegmatogenous retinal detachment was more frequent in men (65.8%) than in women (34.2%, P < 0.001) and in right (52%) than in left eyes (48%, P = 0.045). Phakic RRD affected less quadrants and was less likely to be associated with macula-off status than pseudophakic RRD (48.4% vs. 58.0% macula off, 23% vs. 31% >= 3 quadrants, P < 0.001). Laser flare of affected eyes was significantly higher compared with fellow eyes (12.6 +/- 15.2 vs. 8.3 +/- 7.4 pc/ms, P < 0.001). The factors age, sex, lens status, presence of RRD, and the number of quadrants affected were independent influencing factors on laser flare. R2 was 0.145 for phakic and 0.094 for pseudophakic eyes. Conclusion: The results indicate that there may be more factors affecting laser flare than previously assumed. This might limit flare as predictive value for PVR and retinal redetachment.
Pharmacological agents known to stimulate monoamine systems improve memory, and destruction of the dopaminergic systems or dopamine depletion lead to impairments in various learning-related tasks. These reported effects of the central dopaminergic system imply the involvement of D2 receptors. The aim of the present study was to investigate changes in [3H]spiroperidol binding in seven areas of rat brain following informal and active avoidance learning. Littermate male and female rats were reared until 3 months of age in standard colony conditions and treated as active controls or in enriched environmental conditions and exposed to pole-jump active avoidance trials. Female rats acquired avoidance behavior more rapidly than males. Among the brain regions, only the hippocampus showed significant variations in D2 receptor binding between the groups; sex differences and learning-sex interaction were observed in the corpus striatum. There was an inverse correlation between learning performance and hippocampal D2 receptor binding. Our results show that learning affects hippocampal D2 receptors in a sexually dimorphic pattern.
Proliferative vitreoretinopathy (PVR) is the major cause for surgical failure after primary rhegmatogenous retinal detachment (RRD). So far, no therapy has been proven to prevent PVR. Promising results for 5-fluorouracil (5-FU) and low-molecular weight heparin (LMWH) in high-risk eyes have been reported previously. The objective of this trial was to examine the effect of adjuvant intravitreal therapy with 5-FU and LMWH compared with placebo on incidence of PVR in high-risk patients with primary RRD.Randomized, double-blind, controlled, multicenter, interventional trial with 1 interim analysis.Patients with RRD who were considered to be at high risk for PVR were included. Risk of PVR was assessed by noninvasive aqueous flare measurement using laser flare photometry.Patients were randomized 1:1 to verum (200 mg/ml 5-FU and 5 IU/ml dalteparin) and placebo (balanced salt solution) intravitreally applied during routine pars plana vitrectomy.Primary end point was the development of PVR grade CP (full-thickness retinal folds or subretinal strands in clock hours located posterior to equator) 1 or higher within 12 weeks after surgery. For grading, an end point committee assessed fundus photographs. Secondary end points included best-corrected visual acuity and redetachment rate. A group sequential design with 1 interim analysis was applied using the O'Brien and Fleming boundaries. Proliferative vitreoretinopathy grade CP incidence was compared using a Mantel-Haenszel test stratified by surgeon.A total of 325 patients in 13 German trial sites had been randomized (verum, n = 163; placebo, n = 162). In study eyes, mean laser flare was 31 ± 26 pc/ms. No significant difference was found in PVR rate. Primary analysis in the modified intention-to-treat population results were: verum 28% vs. placebo 23% (including not assessable cases as failures); odds ratio [OR], 1.25; 95% confidence interval [CI], 0.76-2.08; P = 0.77. Those in the per-protocol population were: 12% vs. 12%; OR, 1.05; 95% CI, 0.47-2.34; P = 0.47. None of the secondary end points showed any significant difference between treatment groups. During the study period, no relevant safety risks were identified.Rate of PVR did not differ between adjuvant therapy with 5-FU and LMWH and placebo treatment in eyes with RRD.
Eine 86 Jahre alte Patientin wurde mit rezidivierendem Anstieg des Intraokulardrucks (IOD) und Uveitis unklarer Genese des linken Auges bei zunehmender Befundverschlechterung unserer UveitisSprechstunde zugewiesen. Die Patientin berichtete über eine fortschreitende, schmerzlose Visusminderung links, welche im Januar begonnen hätte. Bei Verdacht auf eine glaukomatozyklitische Krise im Sinne eines Posner-SchlossmanSyndroms erfolgte eine externe Vorstellung im April des gleichen Jahres, wobei zunächst eine Vorderkammerpunktionmit anschließender Katarakt-Operation und bei ausbleibendem Therapieansprechen und persistierender Erhöhung des IOD eineTrabekulektomiedurchgeführtwurden. Die genannten Eingriffe erfolgten innerhalb von 14 Tagen. Zu diesem Zeitpunkt lagenweder einedokumentierteRaumforderung der Iris oder des Ziliarkörpers noch
Purpose: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. Methods: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. Results: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. Conclusion: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.
In this study, the test-retest-reliability as one aspect of reliability of metamorphopsia measurements using a computer-based measuring method was determined in patients with macular diseases. Metamorphopsia amplitude, position, and area were quantified using AMD - A Metamorphopsia Detector software (app4eyes GmbH & Co. KG, Germany) in patients with diabetic, myopic, or uveitic macular edema, intermediate or neovascular age-associated macular degeneration, epiretinal membrane, vitelliform maculopathy, Irvine-Gass syndrome, or macular edema due to venous retinal occlusion. The intraclass correlation coefficient (ICC) was calculated in order to determine the repeatability of two repeated measurements and was used as an indicator of the reliability of the measurements. In this study, metamorphopsia measurements were conducted on 36 eyes with macular diseases. Metamorphopsia measurements made using AMD - A Metamorphopsia Detector software were highly reliable and repeatable in patients with maculopathies. The intraclass correlation coefficient of all indices was excellent (0.95-0.97). For diseases of the vitreoretinal interface or macular diseases with intra- or subretinal edema, this metamorphopsia measurement represents a supplement for visual function testing in the clinic, as well as in clinical studies.
BACKGROUND/AIMS:The prospective, non-interventional ORCA module of the OCEAN study (Observation of Treatment Patterns with Lucentis in Approved Indications) evaluated the qualiy of spectral domain-optical coherence tomography (SD-OCT) image interpretation and treatment decisions by clinicians in Germany and the impact on visual outcomes over 24 months in patients with neovascular age-related macular degeneration (nAMD).METHODS:2286 SD-OCT scans of 205 eyes were independently evaluated by clinicians and reading centres (RCs) regarding signs of choroidal neovascularisation (CNV) activity, including presence of intraretinal fluid, subretinal fluid, and/or increase in pigment epithelial detachments. Agreement between clinicians and RCs was calculated. Treatment decisions by clinicians and the impact on treatment outcomes were evaluated.RESULTS:CNV activity was detected by RCs on 1578 scans (69.0%) and by clinicians on 1392 scans (60.9%), with agreement in 74.9% of cases. Of the 1578 scans with RC detected CNV activity, anti-vascular endothelial growth factor injections were performed by clinicians in only 35.5% (560/1578). In 19.7% of cases (311/1578), lack of treatment was justified by patients request, termination criteria or chronic cystoid spaces without other signs for CNV activity. In 44.8% of cases (707/1578) with RC detected CNV activity, clinicians claimed no treatment was necessary despite having correctly detected CNV activity in about 2/3 of these cases. In 34% of cases with presumed undertreatment, visual acuity declined in the following visit.CONCLUSION:Although broad agreement on CNV activity parameters was observed between clinicians and RCs, correct identification of CNV activity did not always lead to the initiation of (re-)treatment. To preserve vision over time, correct interpretation of SD-OCT scans and careful retreatment decisions are required.TRIAL REGISTRATION NUMBER:NCT02194803.
Due to their complexity, globe ruptures are highly compromising traumas for the patient. This is due on the one hand to the eye injury itself with the accompanying loss of vision and on the other hand due to the need for extended treatment with uncertain prognosis and the resulting psychological stress. Globe ruptures are among the prognostically most unfavorable injuries due to the force and peak pressure impacting the eye. Furthermore, contusional retinal necrosis may be of significance prognostically. In the present review, we discuss treatment of globe ruptures involving retinal surgery. We discuss the primary sugery, its chronological planning and extent as well as the necessity for follow-up interventions. We also discuss the origin of traumatic retinal detachment with differential diagnosis of giant retinal tear versus oradialysis as well as secondary sequelae of traumas such as formation of macular holes and their treatment. On this basis, the use of buckling surgery versus pars-plana vitrectomy is discussed. Further focus is set on the role of the iris lens diaphragm in surgery of globe ruptures.
Background The purpose of this investigation was to analyse the ophthalmic follow-up care of former pre-term and fullterm born infants aged 4 to 10 years in the clinical practice and the comparison to the recommendations of the national ophthalmic guidelines. Methods For the prospective Wiesbaden Prematurity Study (WPS), 503 infants were examined: 239 former pre-term infants (PT) with gestational age (GA) <= 32 weeks and 264 former full-termborn infants (FT) with a GA >= 37 weeks aged 4 to 10 years. Ophthalmic examination was performed including refractive measurements and orthoptic examination. Anisometropia was defined as a difference of >= 1 D spherical equivalent. Data was assessed if an ophthalmological examination was performed after hospital discharge, and how many times the ophthalmologist was contacted within the last 12 months. Results Overall, strabismus and anisometropia were present in 18 and 10% of all PT, and in 2 and 5% of all FT infants, respectively. In infants aged 4 to 6 years, 65% of all former PT and 42% of all former FT had ophthalmological contacts within the last year ( p = 0.002). 15% of the pre-term infants with strabismus did not have an ophthalmological examination within the last year. The parents of three former pre-term infants reported that they never had an ophthalmologic examination after hospital discharge. Conclusion Two-thirds of the former pre-terminfants participated in a screening examination at the age of 4 to 6 years in the last year according to their parents, which is recommended by the guidelines for the care of former pre-term infants. There is still room for improvement to provide best ophthalmological care for this vulnerable population that have high risk for strabismus and amblyopia.
The Argus II retinal prosthesis (Second Sight Medical Products, Sylmar, CA, USA) is an electronic epiretinal implant designed for use in patients with end-stage retinitis pigmentosa, as well as for other outer retinal degenerative conditions, such as choroideremia, Leber’s congenital amaurosis, Bardet-Biedl syndrome, Usher syndrome and rod–cone disease.1 This device was tested in a clinical trial of 30 subjects in the USA and in Europe to measure the rate of serious adverse events (SAEs) and to assess its effects on functional vision and visual acuity.2–4 Subjects performed better on visual tasks with the device turned on and retained these improvements at 5 years postsurgery.4 Additionally, an acceptable safety profile enabled approval of the device for consumer use by the European regulatory authorities in 2011 (Conformite Europeenne (CE) mark) and by the US Food and Drug Administration (FDA) in 2013 (FDA approval). The implant is composed of an extraocular component, namely, an electronics case and implant coil, as well as an intraocular component involving a 60-electrode array that is tacked over the macula (figure 1). The extraocular and intraocular components are connected by a trans-scleral silicone-coated polyamide electrode cable, and the implantation procedure involves a 5.2 mm pars plana sclerotomy incision to insert the electrode array and the electrode cable into the eye. The sclerotomy is then sutured around the cable and covered by an allograft or autograft material.5 Figure 1 The Argus II retinal prosthesis. Labelled image of the Argus II implant (adapted from Humayun et al 2). As with any system having both intraocular and extraocular components, the trans-scleral electrode cable that traverses the sclerotomy permanently is a high-risk feature of the device, as leakage through the pars plana incision can result in chronic hypotony. The percentages of clinical trial subjects who experienced hypotony were 10.0% at …
Background The ORCA module of the non-interventional OCEAN study investigated the use of retinal imaging diagnostics in the clinical treatment of patients undergoing vascular endothelial growth factor (VEGF) inhibitor treatment as part of routine clinical care. This article analyzes the agreement between the diagnosis documented by the treating ophthalmologist and the evaluation of reading centers at baseline as well as the effect on the response to treatment during the course. Methods A total of 396 patients (age 75.4 years) were enrolled in which ranibizumab treatment was indicated by the treating ophthalmologist due to either diabetic macular edema (DME), neovascular age-related macular degeneration (nvAMD) or retinal venous occlusion (RVO). Over a period of 24 months, patient and examination data, treatments and interpretation of retinal imaging data by the treating ophthalmologist were systematically recorded. Furthermore, retinal imaging data were also evaluated by three reading centers. Results In 338 out of 396 (85.4%) study eyes, the baseline diagnosis of the treating ophthalmologist was confirmed by the reading centers (DME 87.5%, nvAMD 82.3%, RVO 94.9%). In 17 of the remaining 58 eyes with a discrepant diagnosis, there was at least a consensus with respect to the indications for VEGF inhibitor therapy. The differential diagnoses included a variety of different retinal diseases. During follow-up of up to 3 months, eyes with a consistent diagnosis showed a clear increase in visual acuity (6.4 versus 2.7 letters, p= 0.05) and greater decrease in central retinal thickness (-112.3 versus -24.4 mu m, p< 0.0001). Discussion The initial treatment decision for anti-VEGF therapy with consideration of the differential diagnoses can be challenging. Accurate evaluation of the clinical and imaging findings along with appropriate expertise appear to be important. The observation of superior initial response in eyes with a consensus of the diagnosis at baseline underlines the relevance of an adequate initial assessment for a successful treatment outcome.