苯肾上腺素滴眼液在一项随机 2b 期临床试验中逆转了药理学诱导的散瞳。

Kentucky College of Optometry, Pikeville, Kentucky.

Athens Eye Care, Athens, Ohio.

Optom Vis Sci. 2021 Mar 1;98(3):234-242. doi: 10.1097/OPX.0000000000001656.

SIGNIFICANCE

After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations.

PURPOSE

The protracted reversal time after pharmacologically induced pupil dilation impairs vision. We tested the hypothesis that PMOS rapidly reduces pupil diameter in this acute indication.

METHODS

In this double-masked placebo-controlled, randomized, two-arm crossover phase 2b trial, we evaluated the effects of one drop of 1% PMOS applied bilaterally in subjects who had their pupils dilated by one of two common mydriatic agents: 2.5% phenylephrine or 1% tropicamide. End points included change in pupil diameter, percent of subjects returning to baseline pupil diameter, and accommodative function at multiple time points.

RESULTS

Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide). Change in pupil diameter from baseline at 2 hours after maximal dilation with 1% PMOS was -1.69 mm and was significantly greater in magnitude compared with placebo for every time point beyond 30 minutes (P < .05). At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001). More subjects treated with PMOS in the tropicamide subgroup had at least one eye returning to baseline accommodative amplitude at 2 hours (63 vs. 38%, P = .01). There were no severe adverse events, with only mild to moderate conjunctival hyperemia that resolved in most patients by 6 hours.

CONCLUSIONS

Phentolamine mesylate ophthalmic solution at 1% reversed medically induced pupil dilation more rapidly than placebo treatment regardless of which mydriatic was used (adrenergic agonists and cholinergic blockers) with a tolerable safety profile.

意义

在进行散瞳眼部检查后，许多患者会出现长时间的畏光、视力模糊和与药物性散瞳相关的睫状肌麻痹等症状。甲磺酸苯肾上腺素眼用溶液（PMOS）可能会加速患者散瞳的逆转，有助于恢复视力功能，并减少获得散瞳检查的障碍。

目的

药物诱导的瞳孔扩张后逆转时间延长会损害视力。我们检验了 PMOS 能在这种急性适应证中快速缩小瞳孔直径的假设。

方法

在这项双盲安慰剂对照、随机、两臂交叉 2b 期试验中，我们评估了在两种常见散瞳剂（2.5%苯肾上腺素或 1%托品酰胺）散瞳的受试者中，双侧使用一滴 1%PMOS 的效果。终点包括瞳孔直径的变化、恢复到基线瞳孔直径的受试者比例，以及多个时间点的调节功能。

结果

31 名受试者完成了研究（15 名用苯肾上腺素散瞳，16 名用托品酰胺散瞳）。与安慰剂相比，在最大散瞳后 2 小时，用 1%PMOS 治疗后，瞳孔直径从基线的变化为-1.69 毫米，在 30 分钟后的每个时间点都具有更大的幅度（P<0.05）。在 2 小时时，与安慰剂相比，更多接受 1%PMOS 治疗的研究眼恢复到基线瞳孔直径（29%比 13%，P=0.03），在 4 小时时也有同样的情况（P<0.001）。在托品酰胺亚组中，更多接受 PMOS 治疗的患者在 2 小时时有至少一只眼的调节幅度恢复到基线（63%比 38%，P=0.01）。没有严重的不良事件，只有轻度到中度的结膜充血，大多数患者在 6 小时内缓解。