目的: 探讨 ETDRS 对数视力表对儿童视力检查的可重复性及其影响的相关因素。

方法: 在流行病学调查的过程中, 随机使用 ETDRS 对数视力表, 为 250 位裸眼视力低于 0.5 和 98 位视力正常儿童进行裸眼视力重复检查。
结果: 两次视力测量之间差异的均数为0.004log^±0.07; Kappa 分析结果具有很好的一致性(k = 0.71) ; 性别与视力检查一致性无明显相关(P = 0.845) ; 年龄与视力检查一致性有显著相关性(P = 0.019) , 年龄越小视力检查一致性越差; 屈光不正与视力检查一致性也有显著相关性(P = 0.000) , 近视度数在- 1.00D～- 5.00D 之间的儿童视力检查一致性相对差, 而正视眼的视力检查一致性较好。

结论: 结果提示 ETDRS 对数视力表适合儿童视力检查, 建议推广使用。

Purpose: To evaluate repeatability of the ETDRS log MAR visual acuity measurementin children and the relative influence factors.

Methods: The children (n = 348) with visual acuity less than 0.5 ( equal to 0.3 logunit) in either eye,or one tenth in children with normal visual acuity were chosen todo repeatable uncorrected VA measurement with Bland-Altman analysis and Kappa analysis using ETDRS acuity chart.

Results: The mean difference of visual acuity was 0.004log^±0.07. There was a significant repeatability (k = 0.71) between two visual acuity examination. There were significant consistent results both on male and female patients (P = 0.845) . A significant relationship was found between age and VA repeatability(P = 0.019) . The VA repeatability could also be influenced by refractive error (P = 0.000) . The acuity measurement in children with emmetropia (k = 0.82) had a higher repeatability than in the children with myopia (k = 0.66) .

Conclusions: The ETDRS visual acuity chart can provide a repeatable measure of visual acuity in children. It is recommended for clinic examination of children. 

目的：宏观了解2015—2020年中国眼科药物临床试验情况，为我国眼科药物的研发和临床研究提供最新数据参考，为相关决策提供依据。方法：自国家药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2015—2020年登记的眼科药物临床试验和相关试验药物信息，汇总分析眼科药物临床试验数量、试验分期、试验范围、适应证、药物类型等。结果：2015年1月1日至2020年12月31日共登记98项眼科临床试验。统计每年眼科药物临床试验登记数量，2020年登记的数量最多(28项，占28.57%)；申办方类型中，国内制药企业(75项，占76.53%)发起的眼科药物临床试验数量远高于外资制药企业(23项，占23.47%)；试验分期中，I期临床试验最多(35项，占35.71%)，III期次之(30项，占30.61%)；药物类型中，生物制品数量最多(55项，占56.12%)，化学药物次之(36项，占36.73%)。结论：近6年来，我国眼科药物临床试验进入蓬勃发展时期，尤其是眼底科领域，近2年发展迅速。在创新药领域，国内制药企业已成为眼科新药研发的中坚力量。但创新药大部分集中在眼底科领域，在青光眼、干眼等领域仍需要继续创新。

Objective: To get a macro understanding of the clinical trials of ophthalmic drugs in China from 2015 to 2020, provide the latest data reference for development of ophthalmic drugs and clinical research in China, and provide the basis for relevant decision-making. Methods: The number of clinical trials and related investigational products from 2015 to 2020 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies. Characteristics on number, stage, scope, indications, type were summarized and depicted. Results: There were 98 ophthalmic clinical trials registered in China from January 1, 2015 and December 31, 2020. The year of 2020 hit the highest record of registered ophthalmic clinical trials for 28, accounting for 28.57%. Among sponsor, 75 (accounting for 76.53%) were initiated by domestic pharmaceutical enterprises, much higher than initiated by foreign pharmaceutical enterprises (23, accounting for 23.47%). Among stage, the quantity of phase I (35, accounting for 35.71%) was the largest, followed by phase III (30, accounting for 30.61%). Among type, the quantity of biological product was the largest (55, accounting for 56.12%), followed by chemical product (36, accounting for 36.73%). Conclusion: The past 6 years have seen vigorous growth of ophthalmic clinical trials, particularly in the last 2 years in the field of fundus. Domestic pharmaceutical enterprises have become the central pillar of ophthalmic drugs renovation. However, their focus is limited to fundus, innovation is still needed in areas such as glaucoma xerophthalmia.