Evaluation of Generic versus Original Prostaglandin Analogues in the Treatment of Glaucoma: A Systematic Review and Meta-Analysis.

TOPIC: An evaluation of the efficacy and tolerability of generic prostaglandin analogues (PGAs) compared with their original counterpart. CLINICAL RELEVANCE: This systematic review was initiated to enlighten ophthalmologists and patients in the use of original and generic ophthalmic solutions. METHODS: A literature search was conducted on PubMed, EMBASE, MEDLINE, Clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform, along with a manual search, from the marketing of the first PGA, latanoprost, in 1995 to the present. Randomized controlled trials comparing an original PGA with its generic counterpart were included. The last literature search was conducted in June 2019. Risk of bias was assessed by 2 independent reviewers using the Cochrane Handbook for Systematic Reviews Tool. The primary outcome was reduction of intraocular pressure (IOP) from baseline. Secondary outcomes included tolerability, ocular surface health, quality of life, disease progression, and cost-effectiveness. Meta-analysis of the primary outcome was planned. RESULTS: Of 385 screened articles, 6 were included in a broad characterization and in the meta-analysis. A total of 619 patients were enrolled. The duration of the studies ranged from 3 to 16 weeks. Meta-analysis of all 6 studies denied any clinically significant difference in efficacy, and the 95% confidence interval included nil (-0.50 to 0.04 mmHg). The evidence was of moderate certainty because of unclear or high risk of bias in all studies. There were no reported differences in tolerability. CONCLUSIONS: Trials comparing original and generic PGAs did not show a clinically significant difference in IOP-lowering effect or tolerability. However, the quality of the trials is suboptimal. Overall, there is uncertainty, and further research is needed to confirm equivalence.

Efficacy and safety evaluation of benzalkonium chloride preserved eye-drops compared with alternatively preserved and preservative-free eye-drops in the treatment of glaucoma: a systematic review and meta-analysis.

BACKGROUND/AIMS: This systematic review compared the efficacy and safety of benzalkonium chloride (BAK)-preserved eye-drops with alternatively preserved (AP) and preservative-free (PF) eye-drops. METHODS: PubMed, EMBASE and MEDLINE were searched for randomised controlled trials in June and October 2019. Study selection, data extraction and risk of bias assessment were made by two independent reviewers using the Cochrane Handbook. Studies on prostaglandin analogue or beta-blocker eye-drops and patients with glaucoma or ocular hypertension were included. Primary outcome was change in intraocular pressure (IOP). Secondary outcomes were safety measures as assessed in original study. RESULTS: Of 433 articles screened, 16 studies were included. IOP meta-analysis was conducted on 13 studies (4201 patients) ranging from 15 days to 6 months. No significant differences between BAK versus PF and AP were identified (95% CI -0.00 to 0.30 mm Hg, p=0.05). Meta-analyses revealed no differences between BAK versus AP and PF with regards to conjunctival hyperaemia (risk ratio (RR) 1.05, 95% CI 0.91 to 1.22, 3800 patients, 9 studies), ocular hyperaemia (RR 1.31, 95% CI 0.96 to 1.78, 2268 patients, 5 studies), total ocular adverse events (RR 1.03, 95% CI 0.88 to 1.20, 1906 patients, 5 studies) or tear break-up time (mean difference 0.89, 95% CI -0.03 to 1.81, 130 patients, 3 studies). Diverse reporting on safety measures made comparison challenging. Risk of bias was assessed as high or unclear in many relevant domains, suggesting potential selective reporting or under-reporting. CONCLUSION: No clinically significant differences on efficacy or safety could be determined between BAK versus AP and PF. However, there were substantial uncertainties on safety.PROSPERO registration numberCRD42019139692.

Visual field defects after temporal lobe resection for epilepsy.

PURPOSE: To determine visual field defects (VFDs) using methods of varying complexity and compare results with subjective symptoms in a population of newly operated temporal lobe epilepsy patients. METHODS: Forty patients were included in the study. Two patients failed to perform VFD testing. Humphrey Field Analyzer (HFA) perimetry was used as the gold standard test to detect VFDs. All patients performed a web-based visual field test called Damato Multifixation Campimetry Online (DMCO). A bedside confrontation visual field examination ad modum Donders was extracted from the medical records in 27/38 patients. All participants had a consultation by an ophthalmologist. A questionnaire described the subjective complaints. REULTS: A VFD in the upper quadrant was demonstrated with HFA in 29 (76%) of the 38 patients after surgery. In 27 patients tested ad modum Donders, the sensitivity of detecting a VFD was 13%. Eight patients (21%) had a severe VFD similar to a quadrant anopia, thus, questioning their permission to drive a car. In this group of patients, a VFD was demonstrated in one of five (sensitivity=20%) ad modum Donders and in seven of eight (sensitivity=88%) with DMCO. Subjective symptoms were only reported by 28% of the patients with a VFD and in two of eight (sensitivity=25%) with a severe VFD. Most patients (86%) considered VFD information mandatory. CONCLUSION: VFD continue to be a frequent adverse event after epilepsy surgery in the medial temporal lobe and may affect the permission to drive a car in at least one in five patients. Subjective symptoms and bedside visual field testing ad modum Donders are not sensitive to detect even a severe VFD. Newly developed web-based visual field test methods appear sensitive to detect a severe VFD but perimetry remains the golden standard for determining if visual standards for driving is fulfilled. Patients consider VFD information as mandatory.

Bystander capability to activate speaker function for continuous dispatcher assisted CPR in case of suspected cardiac arrest.

BACKGROUND: The European Resuscitation Council Guidelines 2015 recommend bystanders to activate their mobile phone speaker function, if possible, in case of suspected cardiac arrest. This is to facilitate continuous dialogue with the dispatcher including (if required) cardiopulmonary resuscitation instructions. The aim of this study was to measure the bystander capability to activate speaker function in case of suspected cardiac arrest. METHOD: In 87days, a systematic prospective registration of bystander capability to activate the speaker function, when cardiac arrest was suspected, was performed. For those asked, "can you activate your mobile phone's speaker function", audio recordings were examined and categorized into groups according to the bystanders capability to activate speaker function on their own initiative, without instructions, or with instructions from the emergency medical dispatcher. Time delay was measured, in seconds, for the bystanders without pre-activated speaker function. RESULTS: 42.0% (58) was able to activate the speaker function without instructions, 2.9% (4) with instructions, 18.1% (25) on own initiative and 37.0% (51) were unable to activate the speaker function. The median time to activate speaker function was 19s and 8s, with and without instructions, respectively. CONCLUSION: Dispatcher assisted cardiopulmonary resuscitation with activated speaker function, in cases of suspected cardiac arrest, allows for continuous dialogue between the emergency medical dispatcher and the bystander. In this study, we found a 63.0% success rate of activating the speaker function in such situations.