Dataset Information

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.

ABSTRACT:

Background/aims

To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.

Methods

In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200??L of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety.

Results

Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7?mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups.

Conclusions

Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane.

Trial registration number

NCT02101359; Results.

SUBMITTER: Labetoulle M

PROVIDER: S-EPMC4941138 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Publications

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.

Labetoulle Marc M Findl Oliver O Malecaze François F Alió Jorge J Cochener Béatrice B Lobo Conceição C Lazreg Sihem S Hartani Dahbia D Colin Joseph J Tassignon Marie-José MJ Behndig Anders A

The British journal of ophthalmology 20151103 7

<h4>Background/aims</h4>To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.<h4>Methods</h4>In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) ...[more]

PMID: 26531052

Similar Datasets

Project description:BackgroundCataract 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.MethodsPost-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.ResultsAmong 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).ConclusionsICMA 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 registrationThe trial was registered at (reference # NCT02101359) on April 2, 2014.

Dataset Information

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.

Background/aims

Methods

Results

Conclusions

Trial registration number

Publications

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.

Similar Datasets

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