Systemic exposure to intracameral vs topical mydriatic agents: in cataract surgery
Received 4 October 2018
Accepted for publication 21 January 2019
Published 3 May 2019 Volume 2019:13 Pages 811—819
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Jose Guell,1 Anders Behndig,2 Uwe Pleyer,3 Stéphane Jaulerry,4 Pascal Rozot,5 Pierre-Jean Pisella,6 Pierre-Yves Robert,7 Ines Lanzl,8 Sayeh Pourjavan,9 Carlos Aguiar,10 Joaquin Fernandez,11 Gunther Grabner,12 Rita Mencucci,13 Frédéric Chiambaretta,14 Marc Labetoulle15
On behalf of the Intracameral Mydrane (ICMA) and Ethics Group
1Cornea and Refractive Surgery Unit, Instituto de Microcirugía Ocular, Barcelona, Spain; 2Department of Clinical Science/Ophthalmology, Umeå University Hospital, Umeå, Sweden; 3Universitäts-Augenklinik, Charité Campus Virchow-Klinik, Berlin, Germany; 4Centre Hospitalier de Bigorre, Tarbes, France; 5Clinique Monticelli, Marseille, France; 6Hôpital Bretonneau, CHRU de Tours, Tours, France; 7Hôpital Dupuytren, CHU de Limoges, Limoges, France; 8Chiemsee Augen Tagesklinik, Prien, Germany; 9Cliniques Universitaires Saint-Luc, Bruxelles, Belgium; 10Hospital de Santo Antonio, Porto, Portugal; 11Hospital Torrecárdenas, Almeria, Spain; 12Universitätsklinik Für Augenheilkunde Und Optometrie, Der Paracelsus, Austria; 13AOU Careggi, Clinica Oculistica, Università Degli Studi di Firenze, Firenze, Italy; 14Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France; 15Hôpital Bicêtre, Université Paris Sud, Paris, France
Objective: The objective of this study was to compare systemic exposure to tropicamide/phenylephrine following intracameral or topical administration before cataract surgery.
Patients and methods: Mydriatics exposure was calculated in patients randomized to intracameral fixed combination of mydriatics and anesthetic ([ICMA]: tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1%, N=271) or mydriatic eye drops ([EDs]: tropicamide 0.5% and phenylephrine 10%, N=283). Additional doses were permitted if required. Mydriatic plasma levels were determined by mass spectrometric HPLC in 15 patients per group before and after administration.
Results: Most ICMA patients (73.6%) received a single dose (200 µL) representing an exposure to tropicamide of 0.04 mg and phenylephrine of 0.62 mg. None of these patients received additional mydriatics. In the control group (three administrations), the exposure was 0.45 (11.3-fold higher than ICMA) and 10.2 (16.5-fold higher) mg. When additional ED was used in this group (9.2% of patients), it was 37.5-fold higher for tropicamide (10 drops, 1.5 mg) and 54.8-fold higher for phenylephrine (10 drops, 34 mg) than the recommended ICMA dose. Tropicamide plasma levels were not detectable at any time point in ICMA patients while it was detectable in all ED patients at 12 and 30 minutes. Phenylephrine was detectable in 14.3% of ICMA patients compared to all ED patients at least at one time point. More ED patients experienced a meaningful increase in blood pressure and/or heart rate (11.2% vs 6.0% of ICMA patients; P=0.03).
Conclusion: Systemic exposure to tropicamide/phenylephrine was lower and cardiovascular (CV) effects were less frequent with ICMA. This could be of particular significance in patients at CV risk.
Keywords: cataract surgery, intracameral mydriasis, topical mydriasis, systemic influence, cardiovascular safety
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