Risultati per: Diagnosi e gestione del glaucoma

Prima in Italia, finanziata dal ministero della Salute

Individuato in una proteina segnale di insorgenza della malattia

Individuato in una proteina segnale di insorgenza della malattia

Dal 9 al 15 marzo la Settimana mondiale della malattia

Alcune sono causa di sordocecità,fondamentale intervento precoce

Alcune sono causa di sordocecità,fondamentale intervento precoce

Introduction
The primary therapeutic approach to glaucoma involves the long-term use of intraocular pressure (IOP)-lowering eyedrops. However, the prevalent use of benzalkonium chloride (BAK) as a preservative in glaucoma eyedrops has been associated with ocular side effects, prompting a demand for alternatively preserved (AP) or preservative-free (PF) eyedrops. Studies comparing various preservatives have shown conflicting evidence concerning the safety of BAK-preserved (BP) eyedrops, some studies indicating no notable concerns and others reporting adverse effects. The current protocol concerns a network meta-analysis enabling systematic investigation of the IOP-lowering efficacy and safety profiles of BP, AP and PF eyedrops in patients with glaucoma for whom randomised controlled trials (RCTs) are available.

Methods and analysis
This study will evaluate the IOP-lowering effects of glaucoma eyedrops, comparing formulations with and without preservatives in patients with glaucoma. A systematic search for RCTs, regardless of language or publication date, will be conducted across three electronic databases (Cochrane search engine, Embase and MEDLINE) from 1 March 2024. Two reviewers will conduct a sequential screening of titles and abstracts, followed by full-text papers, to extract useful data. The two reviewers will also assess the internal validity of studies using the relevant and domain-based risk of bias assessment tool. Overall evidence quality will be assessed using the Confidence in Network Meta-Analysis approach and presented in summarised form with network diagrams. Forest plots will be generated for enhanced visualisation of the included glaucoma eyedrops’ effects, and pairwise effect sizes will be calculated based on available evidence in the network.

Ethics and dissemination
No ethics review or approval is required for this work, as it will synthesise evidence obtained from published studies. A paper presenting the findings will be submitted to a peer-reviewed journal for publication.

PROSPERO registration number
CRD42024498328

Airo: “Radioterapia è speranza, serve integrazione specialisti”

In Italia oltre 100mila con patologie rare non diagnosticate

Nel 2024: +10% di ingressi. Il plauso sindaco di Loreto, Pieroni

In Italia 3500 casi anno fase avanzata,anche 6 mesi per diagnosi

Introduction
Glaucoma is one of the most common causes of blindness and affects more than 70 million people worldwide. The disease is characterised by the loss of retinal ganglion cells associated with a progressive optic neuropathy, resulting in an impairment of visual functions, for example, visual field loss. Nowadays, the only modifiable risk factor is the increase in intraocular pressure, and its treatment is to lower this pressure by medication, laser treatment or surgery to avoid disease progression. New methods for preventing and reversing vision loss are thus urgently needed. Several small and two multicentre studies have presented evidence that repetitive transorbital alternating current stimulation (rtACS) can lead to long-lasting visual field improvement. This could open a new and inexpensive therapeutic option for optic atrophy. However, the level of evidence for this method is still fairly rather poor, and further trials are needed. Therefore, this clinical trial aims to prove the effectiveness of rtACS compared with sham stimulation in patients with primary open-angle glaucoma (POAG).

Methods and analysis
VIRON (Vision Restoration in Optic Neuropathy) is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with three arms. The primary objective is to assess the effectiveness of rtACS in patients with POAG compared with sham stimulation. The primary outcome is the change in mean defect (MD) in the visual field immediately after 10 sessions of rtACS (days 9, 16 and 23) compared with the values of initial perimetry (days –21 to –14 and 0) after applying electrical stimulation with a classical montage, compared with sham and electrical stimulation using individualised montage. Secondary outcome measures comprise a long-term effect with changes in MD at 24 weeks after stimulation, and data from the National Eye Institute Visual Function-25 and quality of life (Short Form 36) questionnaires. The target population are patients with glaucomatous optic atrophy and significant glaucomatous visual field defects (MD of 5–22 dB) due to POAG.
After randomisation, patients received either classical rtACS (group 1), individual rtACS (group 2) or sham stimulation (group 3) in daily 25 min stimulation sessions in two series of five consecutive days separated by a weekend interval. In group 1, active stimulation will be via the routinely applied montage using two electrodes affixed on the right and left side of the head, next to the eyes, with straightforward fixation. In group 2, the current flow will be individually modelled (MRI-based) to target areas of partial visual field defects by optimising electrode positions in conjunction with an optimised visual fixation direction. Group 3 with sham stimulation will serve as control.
The calculated sample size required to achieve a statistical power of 80% for a relevant effect size and allow for dropouts was 300 (100 per group). The trial has already begun with the first patient in July 2023. The planned recruitment period is 24 months with an estimated end of the study in November 2025 (last patient out). An adjusted extension of the study period is planned.

Ethics and dissemination
VIRON was approved by the Central Ethics Committee of the University Medical Center Göttingen (19 October 2022) and those of the individual participating centres (Bonn: 446/23-EP, Hamburg: 2023-200889-BO-bet, Cologne: 23-1487 and Mainz: 2023-17399-§23b). The study protocol complies with the Declaration of Helsinki, the national medicine device regulation (MDR) laws and the international standards of good clinical practice (GCP).
The study protocol (V.5, 24 November 2023) was designed following the Standard Protocol Items: Recommendations for Interventional Trials guidelines and is registered on https://drks.de/search/de/trial/DRKS00029129.
As study initiatior the University Medical Center Göttingen (UMG) is responsible for data ownership and data management of the VIRON study. The study data will be published within 6 months of the study being completed. After the publication of the primary results, all data are anonymised and published in an open-access journal to ensure access to the data for third parties.

Trial registration number
https://drks.de/search/de/trial/DRKS00029129.