Ratanapakorn Tanapat, Yospaiboon Yosanan, Chaisrisawadsuk Natthira
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
J Med Assoc Thai. 2006 Nov;89(11):1934-9.
To compare the efficacy of pupil dilation between a single dose and three doses of 1% tropicamide and 10% phenylephrine for binocular indirect ophthalmoscopy.
A prospective randomized double-blind clinical controlled trial was conducted. All patients underwent the binocular indirect ophthalmoscopy and met the inclusion criteria were randomized into two groups using block randomization. Group A received a single dose of 1% tropicamide and 10% phenylephrine eye drops, and Group B received three doses of the same drugs. The primary outcome was the horizontal pupil diameter measured by slit-lamp biomicroscope (Haag-Streit model 900) before and at 10, 15, 20, 25 and 30 minutes after eye drop instillation. The clinical equivalence of the efficacy of pupil dilation between the two groups was defined as the difference of less than or equal to 1 mm (-1 mm to + 1 mm).
Eighty patients (160 eyes) were randomized into 40 patients (80 eyes) in group A and 40 patients (80 eyes) in group B. The mean pupil sizes at baseline of group A were 3.51 +/- 0.63 mm in the right eye and 3.39 +/- 0.67 mm in the left eye. Those in group B were 3.61 +/- 0.67 mm in the right eye and 3.66 +/- 0.72 mm in the left eye. The mean pupil diameters at 30 minutes of group A were 7.34 +/- 0.51 mm in the right eye and 7.41 +/- 0.56 mm in the left eye, whereas those of group B were 7.49 +/- 0.45 mm in the right eye and 7.51 +/- 0.40 mm in the left eye. The mean difference of the pupil size between the two groups was 0.15 mm (p = 0.175) in the right eye and 0.l0 mm (p = 0.362) in the left eye. The 95% confidence intervals of the difference in pupil size were -0.36 to 0.07 mm in the right eye and -0.32 to 0.12 mm in the left eye.
The 95% confidence interval of the difference in pupil size lay entirely within the range of equivalence. The single dose of 1% tropicamide and 10% phenylephrine was clinically equivalent to the three doses of the same drugs.
比较单剂量与三剂量1%托吡卡胺和10%去氧肾上腺素用于双眼间接检眼镜检查时的散瞳效果。
进行一项前瞻性随机双盲临床对照试验。所有接受双眼间接检眼镜检查且符合纳入标准的患者采用区组随机化方法随机分为两组。A组接受单剂量1%托吡卡胺和10%去氧肾上腺素滴眼液，B组接受三剂量相同药物。主要观察指标为使用裂隙灯显微镜（ Haag-Streit 900型）在滴眼剂滴入前以及滴入后10、15、20、25和30分钟测量的水平瞳孔直径。两组散瞳效果的临床等效性定义为差异小于或等于1毫米（-1毫米至+1毫米）。
80例患者（160只眼）被随机分为A组40例患者（80只眼）和B组40例患者（80只眼）。A组右眼基线平均瞳孔大小为3.51±0.63毫米，左眼为3.39±0.67毫米。B组右眼为3.61±0.67毫米，左眼为3.66±0.72毫米。A组30分钟时右眼平均瞳孔直径为7.34±0.51毫米，左眼为7.41±0.56毫米，而B组右眼为7.49±0.45毫米，左眼为7.51±0.40毫米。两组瞳孔大小的平均差异右眼为0.15毫米（p = 0.175），左眼为0.10毫米（p = 0.362）。瞳孔大小差异的95%置信区间右眼为-0.36至0.07毫米，左眼为-0.32至0.12毫米。
瞳孔大小差异的95%置信区间完全在等效范围内。单剂量1%托吡卡胺和10%去氧肾上腺素在临床上与三剂量相同药物等效。
