Frederic Chiambaretta1, Uwe Pleyer2, Anders Behndig2, Pierre-Jean Pisella2, Erik Mertens2, Antonio Limao2, Francesco Fasce2, Joaquin Fernandez2, Salah-Eddine Benmoussa2, Marc Labetoulle2, Beatrice Cochener2. 1. From Hôpital Gabriel Montpied (Chiambaretta), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, Hôpital Bretonneau (Pisella), Centre Hospitalier Régional et Universitaire de Tours, Tours, Hôpital Bicêtre (Labetoulle), Université Paris Sud, Paris, and Centre Hospitalier Universitaire Morvan (Cochener), Brest, France; the Universitäts-Augenklinik (Pleyer), Charité Campus Virchow-Klinik, Berlin, Germany; Umeå University Hospital (Behndig), Umeå, Sweden; Medipolis (Mertens), Antwerpen, Belgium; Instituto de Microcirugia Ocular (Limao), Lisboa, Portugal; Universitaria Ospedaliero Centro di Oculistica (Fasce), Fondazione Centro S. Raffaele, Milano, Italy; Hospital Torrecárdenas (Fernandez), Almeria, Spain; Clinique d'Ophtalmologie Benmoussa (Benmoussa), Constantine, Algeria. Electronic address: fchiambaretta@chu-clermontferrand.fr. 2. From Hôpital Gabriel Montpied (Chiambaretta), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, Hôpital Bretonneau (Pisella), Centre Hospitalier Régional et Universitaire de Tours, Tours, Hôpital Bicêtre (Labetoulle), Université Paris Sud, Paris, and Centre Hospitalier Universitaire Morvan (Cochener), Brest, France; the Universitäts-Augenklinik (Pleyer), Charité Campus Virchow-Klinik, Berlin, Germany; Umeå University Hospital (Behndig), Umeå, Sweden; Medipolis (Mertens), Antwerpen, Belgium; Instituto de Microcirugia Ocular (Limao), Lisboa, Portugal; Universitaria Ospedaliero Centro di Oculistica (Fasce), Fondazione Centro S. Raffaele, Milano, Italy; Hospital Torrecárdenas (Fernandez), Almeria, Spain; Clinique d'Ophtalmologie Benmoussa (Benmoussa), Constantine, Algeria.
Abstract
PURPOSE: To compare the pupil dynamics of an intracameral combination of 2 mydriatics and 1 anesthetic (Mydrane) to a standard topical regimen for cataract surgery. SETTING:Sixty-two centers in Europe and 6 centers in Algeria. DESIGN: Prospective case series. METHODS:Pupil size measurements were performed in 2 randomized studies (phase 2 and phase 3) under masked conditions (recorded videography, masked reading center). The outcomes in the phase 2 study supported evaluation of the timeframe to obtain pupil dilation and the phase 3 study provided results on mydriasis stability. RESULTS: Phase 2 and phase 3 comprised 139 patients and 591 patients, respectively. After intracameral combination administration, 95% of the pupil dilation was achieved within a mean of 28.6 seconds ± 4.6 (SD). At the beginning of capsulorhexis creation, the mean pupil diameter was larger than 7.0 mm in both groups. The intraoperative pupil diameter remained stable in the intracameral combination group and decreased in the topical group. The mean change in pupil size just before capsulorhexis to the end of surgery (just before cefuroxime injection) was -0.22 ± 0.72 mm and -1.67 ± 0.98 mm, respectively. No clinically significant change in pupil diameter (change <1.0 mm) occurred in the majority of the intracameral combination group (89.3%) compared with the topical group (26.8%). CONCLUSIONS: Intracameral combination of 2 mydriatics and 1 anesthetic is an alternative to topical mydriatics for cataract surgery. The prompt onset of pupil dilation and the stable mydriasis induced by this drug combination improved the intraoperative conditions during crucial steps, such as intraocular lens implantation.
RCT Entities:
PURPOSE: To compare the pupil dynamics of an intracameral combination of 2 mydriatics and 1 anesthetic (Mydrane) to a standard topical regimen for cataract surgery. SETTING: Sixty-two centers in Europe and 6 centers in Algeria. DESIGN: Prospective case series. METHODS: Pupil size measurements were performed in 2 randomized studies (phase 2 and phase 3) under masked conditions (recorded videography, masked reading center). The outcomes in the phase 2 study supported evaluation of the timeframe to obtain pupil dilation and the phase 3 study provided results on mydriasis stability. RESULTS: Phase 2 and phase 3 comprised 139 patients and 591 patients, respectively. After intracameral combination administration, 95% of the pupil dilation was achieved within a mean of 28.6 seconds ± 4.6 (SD). At the beginning of capsulorhexis creation, the mean pupil diameter was larger than 7.0 mm in both groups. The intraoperative pupil diameter remained stable in the intracameral combination group and decreased in the topical group. The mean change in pupil size just before capsulorhexis to the end of surgery (just before cefuroxime injection) was -0.22 ± 0.72 mm and -1.67 ± 0.98 mm, respectively. No clinically significant change in pupil diameter (change <1.0 mm) occurred in the majority of the intracameral combination group (89.3%) compared with the topical group (26.8%). CONCLUSIONS: Intracameral combination of 2 mydriatics and 1 anesthetic is an alternative to topical mydriatics for cataract surgery. The prompt onset of pupil dilation and the stable mydriasis induced by this drug combination improved the intraoperative conditions during crucial steps, such as intraocular lens implantation.