[Clinical evaluation of the ocular safety of Amukine 0.06% solution for local application versus povidone iodine (Bétadine) 5% solution for ocular irrigation) in preoperative antisepsis].
BACKGROUND
The aim of this monocentric, randomized, comparative, open study was to evaluate the safety of Amukine 0.06% solution (an isotonic hypochloride sodium solution) versus a 5% povidone iodine solution (Bétadine 5% solution for ocular irrigation) in antisepsis before cataract surgery.


METHODS
One hundred and thirteen patients, aged between 49 and 90 years, were included and split, after randomization, into two groups: one testing Amukine 0.06%, the other testing a 5% povidone iodine solution. For each group, after local anesthesia, the antiseptic procedure consisted of an antisepsis of periocular teguments followed by an eye antisepsis through the instillation of two drops of the tested product in the conjunctival fornices. The safety evaluation was performed by grading superficial punctate keratitis 24 hours after surgery (slit lamp examination after fluorescein instillation). Conjunctival hyperemia scores by examination of the bulbar conjunctiva before the first instillation, immediately before surgery, and 24 hours after surgery were also compared.


RESULTS
One hundred and seven reports were analyzed. Concerning the presence of corneal superficial punctate keratitis 24 hours after surgery, mean scores were not different (0.27 for the Amukine 0.06% group and 0.38 for the povidone iodine group; p=0.27 Mann Whitney test). The observations did not show a different progression of conjunctival hyperemia depending on the treatment group (p=0.65 (immediately after application) and p=0.52 (after 24 hours); Mann Whitney test).


CONCLUSIONS
In this study, the ocular safety of Amukine 0.06% solution was not different from a 5% povidone iodine solution. Therefore, Amukine 0.06% is a new interesting approach to surgical antisepsis in ophthalmology and an alternative in case of iodine allergy.
Auclin
F
F
Service d'Ophtalmologie 3, ru Charenton, 75012 Paris, France.
Rat
P
P
Tuil
E
E
Boureau-Andrieux
C
C
Morel
C
C
Laplace
O
O
Cambourieu
C
C
Limon
S
S
Nordmann
J P
JP
Laroche
L
L
Baudouin
C
C
D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000494:pharmacology*; D000985:Antisepsis; D002387:Cataract Extraction / Q000009:adverse effects; D003228:Conjunctiva / Q000098:blood supply; D004202:Disinfectants / Q000008:administration & dosage / Q000494:pharmacology*; D005123:Eye / Q000187:drug effects*; D005260:Female; D006801:Humans; D006940:Hyperemia / Q000209:etiology; D007466:Iodophors / Q000008:administration & dosage / Q000494:pharmacology*; D007634:Keratitis / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011206:Povidone-Iodine / Q000008:administration & dosage / Q000494:pharmacology*; D011300:Preoperative Care; D012449:Safety; D012973:Sodium Hypochlorite / Q000008:administration & dosage / Q000494:pharmacology*; D013997:Time Factors
D000891:Anti-Infective Agents, Local; D004202:Disinfectants; D007466:Iodophors; D011206:Povidone-Iodine; D012973:Sodium Hypochlorite
Evaluation clinique de la tolérance oculaire d'Amukine 0,06% solution pour application locale versus povidone iodée (Bétadine 5% solution pour irrigation oculaire) en antisepsie pré-opératoire.