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Background: Although the benefits of intracameral mydriatics have been established in healthy patients, their safety and efficacy in difficult subjects have yet to be determined. Aim: The aim of the study is to assess the safety and efficacy of topical and intracameral application of a combination of tropicamide, phenylephrine and lidocaine during phacoemulsification surgery. Setting: The study was done at the Department of ophthalmology at the University of Bhavnagar, Gujarat, India. Methods: A total of 50 patients were recruited patients who were operated with phacoemulsification surgery. During the intraoperative period, pupil seize was studied and eventual adverse events have been monitored. Also, comfort reported by patients and surgeons has been investigated. Results: It was observed that the intracameral drug combination did not have any impact on blood pressure, pulse rate as well as did not affect the Intra Ocular Pressure (IOP) dynamics and was successful in maintaining pupil size after its application during surgery. Conclusion: The combination also proved effective as an anaesthetic agent, which was proven by pain score findings, as the patients were comfortable and compliant enough to tolerate cataract surgery. Contribution: The mydriatic and anaesthetic combination is efficient enough used topically and intracamerally to carry out phacoemulsification surgery and has a better safety profile when compared with current practices.

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.