Cooper Jeffrey, Eisenberg Nadine, Schulman Erica, Wang Frederick M
*MS, OD †OD ‡MD SUNY College of Optometry (JC, ES), New York, New York; Private Practice (NE), New York, New York; New York Eye and Ear (FMW), New York, New York; and Albert Einstein College of Medicine (FMW), Bronx, New York.
Optom Vis Sci. 2013 Dec;90(12):1467-72. doi: 10.1097/OPX.0000000000000037.
Atropine 1% has been used to slow the progression of myopia; however, it has not gained worldwide clinical acceptance because it results in clinically significant pupillary mydriasis and accommodative paralysis. Lower concentrations of atropine (0.5 to 0.01%) have been reported to be associated with fewer symptoms, while still controlling myopia. It is the purpose of this study to find the highest concentration of atropine that does not result in significant symptoms from pupillary dilation and accommodative paralysis.
A 3 × 3 phase I clinical trial paradigm was used in 12 subjects, to determine the maximum dosage of atropine which could be prescribed without creating symptoms or clinical signs of insufficient accommodation or excessive pupillary dilation. Accommodation was measured by pushouts and pupillary dilation by photography. Prior to this study, we established the following criteria for comfort: 5D or more of residual amplitude of accommodation, less than or equal to a 3 mm pupillary difference between the eyes, and a report of minimal symptoms of near vision blur or outside photophobia.
Our results indicate that atropine 0.02% is the highest concentration that did not result in clinical symptoms and findings associated with higher dosages. Mean pupillary dilation was 3 mm, and mean accommodative amplitude was 8 diopters with this concentration. Further, reduction of the concentration of atropine from 0.02 to 0.01% did not seem to result in a decrease in clinical signs or symptoms associated with atropine.
Atropine 0.02% is the highest concentration that does not produce significant clinical symptoms from accommodation paresis or pupillary dilation. This would be an appropriate starting point in evaluating a low dosage of atropine to slow myopic progression.
1%阿托品已被用于延缓近视进展;然而,它尚未获得全球临床认可,因为它会导致临床上显著的瞳孔散大和调节麻痹。据报道,较低浓度的阿托品(0.5%至0.01%)症状较少,同时仍能控制近视。本研究的目的是找出不会因瞳孔散大和调节麻痹而导致明显症状的最高阿托品浓度。
在12名受试者中采用3×3的I期临床试验范式,以确定在不产生调节不足或瞳孔过度散大的症状或临床体征的情况下可开具的最大阿托品剂量。通过推出法测量调节,通过摄影测量瞳孔散大。在本研究之前,我们确立了以下舒适度标准:调节剩余幅度为5D或更大,双眼瞳孔差异小于或等于3mm,以及近视力模糊或室外畏光的症状轻微。
我们的结果表明,0.02%阿托品是不会导致与较高剂量相关的临床症状和体征的最高浓度。该浓度下平均瞳孔散大为3mm,平均调节幅度为8屈光度。此外,将阿托品浓度从0.02%降至0.01%似乎并未导致与阿托品相关的临床体征或症状减少。
0.02%阿托品是不会因调节麻痹或瞳孔散大而产生明显临床症状的最高浓度。这将是评估低剂量阿托品延缓近视进展的合适起点。