ABSTRACT
Objective:To evaluate the effectiveness and safety of 3.5% lidocaine hydrochloride ophthalmic gel for eye surface anesthesia.Methods:A 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.Results:Within 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 seconds vs. 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). Conclusions:The 3.5% lidocaine hydrochloride is a safe, effective, easy to use and high-quality surface anesthesia drug for eye surgery.
ABSTRACT
Background Neovascular glaucoma (NVG) is a refractory disease characterized by neovascularization,and its pathogenesis mechanism is still unelucidated.Researches showed that muhicytokins and inflammatory factors are associated with neovascularization,however,the correlation of these factors with NVG worth attention.Objective This study was to detect the vescular endothelial growth factor (VEGF),transforming growth factor β1 (TGF-β1) and interleukin-6 (IL-6) levels in aqueous humor and plasma in NVG eyes and its significance.Methods A prospective cases-controlled study was performed under the approval of Ethic Committee of Shanghai East Hospital and informed consent of patients.Eight eyes of 8 NVG patients,10 eyes of 10 primary open angle glaucoma (POAG) patients and 10 eyes of age-related cataract (ARC) patients were entrolled in Shanghai East Hospital from May,2014 to March,2015.The periphery blood of 3-4 ml was collected from all the patients to prepare 0.3-0.4 ml serum,and 0.1-0.2 ml aqueous humor was collected during the surgery from each eye.The aqueous and serum levels of VEGF,TGF-β1 and IL-6 were measured by ELISA.Results The aqueous humor and plasma VEGF concentrations in NVG patients were (2 769.85 ± 390.88) pg/ml and (529.93 ± 95.20) pg/ml,respectively,which were higher than (208.12 ± 58.59) pg/ml and (219.28 ± 24.44) pg/ml in POAG patients as well as (158.88 ±12.35) pg/ml and (172.82±31.91)pg/ml in ARC patients,with significant differences among the three groups (aqueous:F=433.80,P＜0.01;plasma:F=103.84,P＜0.01).The levels of TGF-β1 in aqueous humor and plasma from NVG patients were (157.94±113.00)pg/ml and (3 895.78±2 318.00)pg/ml,showing significant increases in comparison with (54.48±35.58) pg/ml and (2 196.13±1 185.39) pg/ml in the POAG patients or (47.98±17.69) pg/ml and (1937.28±933.27) pg/ml in the ARC patients (aqueous:F =7.88,P＜0.01;plasma:F =4.18,P＜0.05).The concentration of IL-6 in aqueous humor and plasma were (234.87±41.64) pg/ml and (26.97±8.19) pg/ml from NVG patients,with considerable elavation in comparison with (38.97± 19.06)pg/ml and (19.54±5.11)pg/ml in the POAG patients or (29.48±14.61) pg/ml and (18.50±3.57) pg/ml in the ARC patients (aqueous:F =166.27,P＜0.01;plasma:F=5.59,P＜0.05).Conclusions The aqueous and plasma VEGF,TGF-β1 and IL-6 are considerably higher in NVG patients than those in POAG patients and ARC patients,suggesting that these cytokines participate in the pathogenesis and development of the NVG and probably are treating target of NVG.
ABSTRACT
BACKGROUND:Comeal graft endothelial cell density may decline spontaneously at a super-physiological speed after penetrating keratoplasty (PKP),even if no corneal rejection happens,and this is chronic corneal allograff dysfunction (CCAD).OBJECTIVE:To investigate the effects of topical corticosteroid treatment on chronic corneal allograft dysfunction after PKP.DESIGN,TIME AND SETTING:A controlled clinical analysis was performed at the Department of Ophthalmology,Tongji Hospital,Tongji University from May 2004 to May 2009.PARTICIPANTS:A total of 54 patients (eyes) who underwent PKP were included in this study.METHODS:Tobramycin-dexamethasone eyedrops was applied 6 times per day as an initial dosage and tapered during 4 months.Thereafter,drug withdrawal group and long term group were randomly divided.Treatments were ceased in the drug withdrawal group but were continued in the long-term group with a dosage of twice per day till 12 months after surgery.MAIN OUTCOME MEASURES:Corneal graft endothelial cell density was followed up.The mean follow up pedod was 3.12±0.28years.RESULTS:The corneal graft endothelial cell density of drug withdrawal and long term groups was dramatically declined within 36 months after PKP.At every time point,the endothelial cell density was significantly decreased compared to the last follow up (all P＜0.01 ).The endothelial cell density was decreased from (2 428±2.11) cells/mm~2 and (2 791±2.29) cells/mm~2 to (1 424±124) cells/mm~2 and (1 614±114) cells/mm~2 in the drug withdrawal and long-term groups,respectively.There was significant difference in endothelial cell density between the two groups no matter prior to surgery or at each time points after surgery,but the declination trends of two groups were basically the same,indicating that graft loss of endothelial cell density was not impacted by topical corticosteroid treatment after PKP (P＞0.05).CONCLUSION:Chronic corneal allograft dysfunction after PKP is independent of topical corticosteroid treatment.