Xu Li, Wang Xuemei, Wu Meijing
Hainan Provincial Key Laboratory of Ophthalmology, Hainan Eye Hospital, Zhongshan Ophthalmic Center, Haikou, Hainan Province, China.
Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway St, Baltimore, Maryland, USA, 21205.
Cochrane Database Syst Rev. 2017 Feb 20;2(2):CD010520. doi: 10.1002/14651858.CD010520.pub2.
Glaucoma is a leading cause of irreversible blindness worldwide and the second most common cause of blindness after cataracts. The primary treatment for glaucoma aims to lower intraocular pressure (IOP) with the use of topical medicines. Topical medication instillation techniques, such as eyelid closure and nasolacrimal occlusion when instilling drops, have been proposed as potential methods to increase ocular absorption and decrease systemic absorption of the drops.
To investigate the effectiveness of topical medication instillation techniques compared with usual care or another method of instillation of topical medication in the management of glaucoma or ocular hypertension.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1947 to 8 December 2016), PubMed (1948 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), International Pharmaceutical Abstracts Database (1970 to 8 December 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov) (searched 8 December 2016) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) (searched 8 December 2016). We did not use any date or language restrictions in the electronic searches for trials.
We included randomized controlled trials which had compared any topical medication instillation technique with usual care or a different method of instillation of topical medication.
Two review authors independently screened records from the searches for eligibility, assessed the risk of bias, and extracted data. We followed methods recommended by Cochrane.
We identified two trials (122 eyes of 61 participants) that had evaluated a topical medication instillation technique. We also identified two ongoing trials. Both included trials used a within-person design and administered prostaglandin monotherapy for glaucoma or ocular hypertension. Because the trials evaluated different instillation techniques and assessed different outcomes, we performed no meta-analysis.One trial, conducted in the US, evaluated the effect of eyelid closure (one and three minutes) versus no eyelid closure on lowering IOP. At one to two weeks' follow-up, reduction in IOP was similar in the eyelid closure group and the no eyelid closure group (mean difference (MD) -0.33 mmHg, 95% confidence interval (CI) -0.8 to 1.5; 51 participants; moderate-certainty evidence).The second trial, conducted in Italy, evaluated the effect of using an absorbent cloth to wipe excess fluid after instillation (fluid removal) versus not using an absorbent cloth (no removal) on reducing dermatologic adverse events. At four months' follow-up, eyelashes were shorter among eyes in the fluid removal group compared with the no fluid removal group (MD -1.70 mm, 95% CI -3.46 to 0.06; 10 participants; low-certainty evidence). Fewer eyes showed skin hyperpigmentation in the eyelid region towards the nose in the fluid removal group compared with the no removal group (RR 0.07, 95% CI 0.01 to 0.84; 10 participants; low-certainty evidence); however, the difference was uncertain in the eyelid region towards the temples (RR 0.44, 95% CI 0.07 to 2.66; 10 participants; low-certainty evidence). The effect hypertrichosis (excessive hair growth) was uncertain between groups (RR 1.00, 95% CI 0.17 to 5.98; 10 participants; low-certainty evidence).Neither trial reported other outcomes specified for this review, including the proportion of participants with IOP less than 21 mmHg; participant-reported outcomes related to the ease, convenience, and comfort of instillation techniques; physiologic measurements of systemic absorption; escalation of therapy; mean change in visual fields; optic nerve progression; mean change in best-corrected visual acuity; proportion in whom glaucoma developed; quality of life outcomes; or cost-effectiveness outcomes. Neither trial reported data at follow-up times of more than four months.
AUTHORS' CONCLUSIONS: Evidence to evaluate the effectiveness of topical medication instillation techniques for treatment of glaucoma is lacking. It is unclear what, if any, effects instillation techniques have on topical medical therapy for glaucoma.
青光眼是全球不可逆性失明的主要原因,是仅次于白内障的第二大致盲原因。青光眼的主要治疗目标是使用局部药物降低眼压(IOP)。局部用药滴注技术,如滴眼药水时闭眼和鼻泪管阻塞,已被提议作为增加眼部药物吸收和减少全身药物吸收的潜在方法。
研究局部用药滴注技术与常规护理或其他局部用药滴注方法相比,在青光眼或高眼压症治疗中的有效性。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(其中包含Cochrane眼科和视力试验注册库)(2016年第12期)、MEDLINE Ovid(1946年至2016年12月8日)、Embase Ovid(1947年至2016年12月8日)、PubMed(1948年至2016年12月8日)、LILACS(拉丁美洲和加勒比健康科学文献数据库)(1982年至2016年12月8日)、国际药学文摘数据库(1970年至2016年12月8日)、对照试验元注册库(mRCT)(www.controlled-trials.com)(最后检索时间为2013年5月13日)、ClinicalTrials.gov(www.clinicaltrials.gov)(检索时间为2016年12月8日)和世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)(检索时间为2016年12月8日)。我们在电子检索试验时未使用任何日期或语言限制。
我们纳入了将任何局部用药滴注技术与常规护理或不同的局部用药滴注方法进行比较的随机对照试验。
两位综述作者独立筛选检索记录以确定是否符合纳入标准,评估偏倚风险,并提取数据。我们遵循Cochrane推荐的方法。
我们确定了两项评估局部用药滴注技术的试验(61名参与者的122只眼)。我们还确定了两项正在进行的试验。两项试验均采用自身对照设计,对青光眼或高眼压症采用前列腺素单一疗法。由于试验评估了不同的滴注技术并评估了不同的结局,我们未进行荟萃分析。一项在美国进行的试验评估了闭眼(1分钟和3分钟)与不闭眼对降低眼压的效果。在1至2周的随访中,闭眼组和不闭眼组的眼压降低情况相似(平均差(MD)-0.33 mmHg,95%置信区间(CI)-0.8至1.5;51名参与者;中等确定性证据)。第二项在意大利进行的试验评估了滴注后使用吸水布擦拭多余液体(液体清除)与不使用吸水布(未清除)对减少皮肤不良事件的效果。在4个月的随访中,液体清除组的眼睛睫毛比未清除组短(MD -1.70 mm,95% CI -3.46至-0.06;10名参与者;低确定性证据)。与未清除组相比,液体清除组在靠近鼻子的眼睑区域出现皮肤色素沉着的眼睛较少(风险比(RR)0.07,95% CI 0.01至0.84;10名参与者;低确定性证据);然而,在靠近太阳穴的眼睑区域差异不确定(RR 0.44,95% CI 0.07至2.66;10名参与者;低确定性证据)。两组之间多毛症(毛发过度生长)的效果不确定(RR 1.00,95% CI 0.17至5.98;10名参与者;低确定性证据)。两项试验均未报告本综述指定的其他结局,包括眼压低于21 mmHg的参与者比例;参与者报告的与滴注技术的 ease、便利性和舒适度相关的结局;全身吸收的生理测量;治疗升级;视野的平均变化;视神经进展;最佳矫正视力的平均变化;青光眼发生的比例;生活质量结局;或成本效益结局。两项试验均未报告超过4个月随访时间的数据。
缺乏评估局部用药滴注技术治疗青光眼有效性的证据。尚不清楚滴注技术对青光眼局部药物治疗是否有任何影响。