Dataset Information

Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients.

ABSTRACT: BACKGROUND:Cataract surgery in diabetics is more technically challenging due to a number of factors including poor intraoperative pupil dilation and a higher risk of vision threatening complications. This study evaluates the safety and efficacy of an intracameral combination of 2 mydriatics and 1 anesthetic (ICMA, Mydrane) for cataract surgery in patients with well-controlled type-2 diabetes. METHODS:Post-hoc subgroup analysis of a phase 3 randomized study, comparing ICMA to a conventional topical regimen. Data were collected from 68 centers in Europe and Algeria. Only well-controlled type-2 diabetics, free of pre-proliferative retinopathy, were included. The results for non-diabetics are also reported. The primary efficacy variable was successful capsulorhexis without additional mydriatic treatment. Postoperative safety included adverse events, endothelial cell density and vision. RESULTS:Among 591 randomized patients, 57 (9.6%) had controlled type 2 diabetes [24 (42.1%) in the ICMA Group and 33 (57.9%) in the Topical Group; intention-to-treat (ITT) set]. Among diabetics, capsulorhexis was successfully performed without additional mydriatics in 24 (96.0%; modified-ITT set) patients in the ICMA Group and 26 (89.7%) in the Topical Group. These proportions were similar in non-diabetics. No diabetic patient [1 (0.5%) non-diabetics] in the ICMA Group had a significant decrease in pupil size (?3?mm) intraoperatively compared to 4 (16.0%; modified-ITT set) diabetics [16 (7.3%) non-diabetics] in the Topical group. Ocular AE among diabetics occurred in 2 (8.0%; Safety set) patients in the ICMA Group and 5 (16.7%) in the Topical Group. Endothelial cell density at 1?month postoperatively was similar between groups in diabetics (P?=?0.627) and non-diabetics (P?=?0.368). CONCLUSIONS:ICMA is effective and can be safely used in patients with well-controlled diabetes, with potential advantages compared to a topical regimen including reduced systemic risk, better corneal integrity and reduced risk of ocular complications. TRIAL REGISTRATION:The trial was registered at (reference # NCT02101359) on April 2, 2014.

SUBMITTER: Labetoulle M

PROVIDER: S-EPMC7055021 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients.

Labetoulle Marc M Behndig Anders A Tassignon Marie-José MJ Nuijts Rudy R Mencucci Rita R Güell José Luis JL Pleyer Uwe U Szaflik Jacek J Rosen Paul P Bérard Alain A Chiambaretta Frédéric F Cochener-Lamard Béatrice B

BMC ophthalmology 20200303 1

<h4>Background</h4>Cataract surgery in diabetics is more technically challenging due to a number of factors including poor intraoperative pupil dilation and a higher risk of vision threatening complications. This study evaluates the safety and efficacy of an intracameral combination of 2 mydriatics and 1 anesthetic (ICMA, Mydrane) for cataract surgery in patients with well-controlled type-2 diabetes.<h4>Methods</h4>Post-hoc subgroup analysis of a phase 3 randomized study, comparing ICMA to a con ...[more]

PMID: 32126990

Similar Datasets

Project description:BackgroundRe-operative mitral valve surgery is sometimes burdened by a greater technical difficulty and a higher complications rate than the first operation. Minimally invasive cardiac surgery has become routine, and it could significantly reduce the surgical risk in redo surgery. The objective of our retrospective observational study is to assess the results of cardiac reoperations in patients with mitral valve disease approached trough a 5-7 cm right mini-thoracotomy.MethodsFrom February 2017 to December 2019, 65 patients underwent re-operative mitral valve surgery in our institution. Cardiopulmonary bypass (CPB) was started by cannulation of the femoral and jugular vein and femoral artery or alternatively right axillary artery. Patients enrolled had a mean age of 66.6±11.5 years. Patients were divided into three groups based on the procedure adopted: external aortic cross-clamp (EAC), EndoAortic balloon occlusion (EABO) and ventricular fibrillation (VF). Major complications were evaluated and compared with a propensity matched population of patients undergoing elective isolated mitral valve surgery via right minithoracotomy (MVS).ResultsThe average time between last operation and reoperation was 7.1±3.4 years. Fourteen patients (21%) underwent mitral valve repair and 51 patients (78%) underwent mitral valve replacement; 9 patients (14%) received tricuspid valve surgery. There was no statistically significant difference in CPB time between the groups. Seven patients (11%) had a postoperative renal failure, 5 patients (8%) underwent surgical reopening for bleeding; incidence of post-operative stroke and pace-maker implantation was 3% for both. No deaths were registered during in-hospital stay and at 30-days echocardiographic control all patients respect the criterions of device success according with MVARC. Propensity matched patients of group redo had a longer CPB time (100.8±42.7 versus 72.8±16.7 min, P<0.001) and cross-clamp time (71.9±30.7 versus 59±10.7 min, P<0.001) respect to first operation mitral valve surgery patients.ConclusionsMinimally invasive mitral valve redo surgery is a safe procedure. Less invasive techniques in redo surgery could minimize morbidity and mortality without prolonging the duration of CPB.

Dataset Information

Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients.

Publications

Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets