Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial

Background: We reported that in our previous study that wearing intermittent occlusion therapy glasses (IO-therapy) for 4 hours (h) was non-inferior to patching for 2 h in 3 to 8-year-old children with amblyopia. We hypothesize that an intense regimen of 12-h IO-therapy per day for 4 weeks could be as effective as the standard regimen of 4-h IO-therapy per day for 12 weeks in treating moderate amblyopia in 3 to 8-year-old children. Methods/design: A total of 56 children between 3 and 8 years of age with amblyopia in association with anisometropia and/or strabismus will be enrolled. All participants will be prescribed IO-therapy glasses (Amblyz™), set at 30-s opaque/transparent intervals (i.e., occluded 50% of wear time). They will be randomized to receive the standard regimen for 12 weeks or the intense regimen for 4 weeks. Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor. The primary study objective is to compare the effectiveness of an intense regimen to a standard regimen of IO-therapy in 3 to 8-year-old children with moderate amblyopia. The secondary study objectives are to determine whether adherence differs between an intense regimen and a standard regimen of IO-therapy, and to determine the dose-response relationship of IO-therapy. Discussion: In addition to testing the effectiveness, this study will test for the first time the association between treatment adherence and the visual outcome of IO-therapy, which will enhance our understanding of the dose-response relationship of IO-therapy. If an intense regimen is shown to be effective, it would alter amblyopia treatment strategies and improve visual outcomes. Trial registration: ClinicalTrials.gov: NCT02767856. Registered on 10 May 2016

The use of the CNIC-Polypill in real-life clinical practice: opportunities and challenges in patients at very high risk of atherosclerotic cardiovascular disease – expert panel meeting report

Although the cardiovascular (CV) polypill concept is not new and several guidelines state that a CV polypill should be considered an integral part of a comprehensive CV disease (CVD) prevention strategy, there are still some barriers to its implementation in the real-world setting, mainly in secondary CV prevention. As the CNIC-polypill is the only one approved for secondary CV prevention in patients with atherosclerotic CVD in 27 countries worldwide, a panel of four discussants and 30 participants from 18 countries conveyed in a virtual meeting on April 21, 2022, to discuss key clinical questions regarding the practical use of the CNIC-Polypill and barriers to its implementation. Data presented showed that, although the use of the CV polypill is not explicitly mentioned in the current 2021 European Society of Cardiology guidelines on CVD prevention, it may be used in any patient for secondary CVD prevention tolerating all their components to improve outcomes through different aspects. The favourable results of the Secondary Prevention of Cardiovascular Disease in the Elderly (SECURE) trial now reinforce this recommendation. The panellists presented algorithms on how to switch from any baseline regimen when starting treatment with the CNIC-polypill in different situations, including patients with hypertension, dyslipidaemia, and a previous CV event; at discharge after a cardiovascular event; in chronic ischemic conditions; and in cases of polypharmacy. The panellists and expert discussants did agree that available studies conducted so far with the CNIC-polypill demonstrate that it is as efficacious as the monocomponents, equipotent drugs, or other therapies; reduces the risk of experiencing recurrent major CV events; improves medication adherence; reduces health care costs and resources compared to patients treated with loose drugs; and the patients prefer it over the multipill strategy. In conclusion, the data presented by the participants provided the evidence behind the use of the CNIC-polypill to help fulfil the goal of encouraging its adoption by physicians.info:eu-repo/semantics/publishedVersio

Morning Glory Disk Anomaly Associated with Absence of Intracranial Internal Carotid Artery

"Morning glory disk anomaly (MGDA) has been associated with numerous other congenital malformations including intracranial vascular abnormalities(1). The latest have been noticed in as many as 45% of cases (2), ranging from segmental narrowing of the Circle of Willis to complete stenosis of the internal carotid artery. We report a case of MGDA associated with agenesis of the intracranial internal carotid artery (ICA).

Asymptomatic Leukemic Optic Nerve Infiltration as Presentation of Acute Lymphoblastic Leukemia Relapse

"We present a 4 year old boy with history of CNS acute lymphoblastic leukemia (ALL) in remission, diagnosed with leukemic optic neuropathy at a routine eye exam.

The Effects of Amblyopia on Visual Evoked Potentials

"Amblyopia is attributed to cortical changes, therefore Visual Evoked Potentials (VEP) testing is well positioned in the diagnosis, prognosis and management of this condition

Tailoring Amblyopia Treatment with visually Evoked Potentials

Amblyopia is a major public health problem. In up to 1/3 of patients the vision does not reach 20/40 despite the most intensive treatment. Currently we cannot predict the prognosis at the time of diagnosis. We aimed to investigate the value of pattern Visual Evoked Potentials (pVEP) in tailoring the treatment as previous studies suggested that shorter p100 latency is correlated to better visual prognosis

Involvement of the Nitricoxidergic System in the Analgesic Effects of Newly Synthesized Nociceptin Analogues After Chronic Immobilization Stress

Stress is known to exert an influence on neuroendocrine, autonomic, hormonal, and immune functioning. Various stress models have been reported to induce analgesia. This is a phenomenon referred to as stress-induced analgesia (SIA). Nociceptin and analogues are neuropeptides, neuromodulators, which are able to inhibit the expression of some forms of SIA. Nociceptin/orphanin FQ(N/OFQ) is a heptadecapeptide, which has been found to play a direct role on pain perception.Nitric oxide (NO) plays an important role in the initiation and maintenance of pain. It is also known that acute and chronic stress induce biochemical changes affecting both pain threshold and behaviour. Thus, endogenous opioid peptides and NO mediate a wide variety of physiological processes, including pain transmission and SIA.The aim of the present study was to investigate the effects of novel analogues of N/OFQ(1-13)NH2, where lysine (Lys) at position 9 and/or 13 was substituted by L-ornithine (Orn) on nociception after chronic immobilization stress (IS) and the involvement of the nitric oxideergic systems in these effects. Analgesic activity was examined by nociceptive test – paw-pressure (PP). All novel analogues of N/OFQ were injected at a dose of 10 μg/kg, NG-nitro-L-arginine methylester (L-NAME, 10 mg/kg) and L-arginine (L-arg, 1 mg/kg). All drugs were dissolved in saline and were injected intraperitoneally (i.p.). The nociceptive tests were performed 10 min after peptide injection. Antinociceptive effects were statistically accessed by ANOVA.In conclusion, we suggest that the nitricoxidergic system after chronic immobilization stress is involved in the analgesic effects of the novel analogues of nociceptin