Clinical Science
Effectiveness and safety evaluation of lidocaine hydrochloride ophthalmic gel for ocular anesthesia: a multicenter randomized double-blind trial
Zhao Jing, Zhao Mingwei, Yao Tao, Cui Hongping, Wang Yong, Jin Xuemin, Han Qi, Liu Fang, Li Qiuming, Chen Xueyi, Dai Hong
Published 2021-05-10
Cite as Chin J Exp Ophthalmol, 2021, 39(5): 404-409. DOI: 10.3760/cma.j.cn115989-20201216-00844
Abstract
ObjectiveTo evaluate the effectiveness and safety of 3.5% lidocaine hydrochloride ophthalmic gel for eye surface anesthesia.
MethodsA multicenter, randomized, double-blind, placebo controlled clinical trial was conducted in 10 hospitals in China from August 2018 to April 2019 under the approval of an Ethics Committee of Beijing Hospital (No.2018BJYYEC-014-02). A total of 220 fellow eyes of 220 subjects who received ocular surgery in one eye were actually enrolled according to a same included criteria in different institutes.The 220 eyes were randomly divided into control group and trail group.Two drops of lidocaine hydrochloride gel were dropped at about 5 mm away from corneal limbus at 6 o'clock direction of experimental eye of the trail group, and the blank gel was used in the eyes of the control group in the same way.The pain sensation was assessed with a 0.3 mm toothless micro forceps on conjunctiva within a specified time, and ''pain'' or ''no pain'' was answered by the subjects.The primary effective indexes, namely the number of eyes and percentage of ''no pain'' within 5 minutes following dropping, as well as the secondary indexes including the onset time point of the drug and the duration of anesthesia were recorded and evaluated.Safety evaluation took ocular and system adverse events into account.
ResultsWithin 5 minutes after dropping, ''no pain'' occurred in 104 eyes (94.55%) and 29 eyes (26.36%) in the trail group and control group, respectively, showing a significant difference between the two groups ( χ2=106.948, P<0.001). And there was a significant difference in anesthesia onset time between the trail group and control group (40.0 secondsvs. 300.0 seconds) (Z=-15.17, P<0.001). The duration of anesthesia was 860.5 (577.5, 1 180.0) seconds in the trail group and 676.0 (280.0, 1 401.0) seconds in the control group, with no statistically significant difference between the two groups (Z=0.898, P>0.05). The incidence of adverse events in the trail group and control group were 5.45% (6/110) and 4.55% (5/110), respectively, without statistical significance between them (P=1.000).
ConclusionsThe 3.5% lidocaine hydrochloride is a safe, effective, easy to use and high-quality surface anesthesia drug for eye surgery.
Key words:
Surface anesthesia, ocular; Lidocaine; Ophthalmic gel; Multicenter randomized double-blind trial
Contributor Information
Zhao Jing
Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
Zhao Mingwei
Department of Ophthalmology, Peking University People's Hospital, Beijing 100044, China
Yao Tao
He Eye Specialist Hospital, Shenyang 110034, China
Cui Hongping
Department of Ophthalmology, Shanghai East Hospital, Shanghai 200120, China
Wang Yong
Wuhan Aier Eye Hospital, Wuhan 430060, China
Jin Xuemin
Henan Eye Hospital, Henan Provincial People's Hospital, Zhengzhou 450003, China
Jin Xuemin is working at The First Affiliated Hospital of Zhengzhou University 450052
Han Qi
Department of Ophthalmology, Tianjin Medical University General Hospital, Tianjin 300052, China
Liu Fang
Department of Ophthalmology, Shanghai Tenth People's Hospital, Shanghai 200072, China
Li Qiuming
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China
Chen Xueyi
Department of Ophthalmology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China
Dai Hong
Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
