Myint Kay Thi, Sahoo Soumendra, Thein Aung Win, Moe Soe, Ni Han
Ophthalmology, Faculty of Medicine, SEGi University, Sibu, Sarawak, Malaysia, 96000.
Cochrane Database Syst Rev. 2015 Oct 9;2015(10):CD010790. doi: 10.1002/14651858.CD010790.pub2.
Sickle cell disease includes a group of inherited haemoglobinopathies affecting multiple organs including the eyes. Some people with the disease develop ocular manifestations due to vaso-occlusion. Vision-threatening complications of sickle cell disease are mainly due to proliferative sickle retinopathy which is characterized by proliferation of new blood vessels. Laser photocoagulation is widely applicable in proliferative retinopathies such as proliferative sickle retinopathy and proliferative diabetic retinopathy. It is important to evaluate the efficacy and safety of laser photocoagulation in the treatment of proliferative sickle retinopathy to prevent sight-threatening complications.
To evaluate the effectiveness of various techniques of laser photocoagulation therapy in sickle cell disease-related retinopathy.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 21 September 2015.We also searched the following resources (24 March 2015): Latin American and Carribean Health Science Literature Database (LILACS); WHO International Clinical Trials Registry Platforms (ICTRP); and ClinicalTrials.gov.
Randomised controlled trials comparing laser photocoagulation to no treatment in children and adults.
Two authors independently assessed trial eligibility, the risk of bias of the included trials and extracted and analysed data. We contacted the trial authors for additional information.
Two trials (341 eyes of 238 children and adults) were included comparing efficacy and safety of laser photocoagulation to no therapy in people with proliferative sickle retinopathy. There were 121 males and 117 females with an age range from 13 to 67 years. The laser photocoagulation technique used was different in the two trials; one single-centre trial employed sectoral scatter laser photocoagulation using an argon laser; and the second, two-centre trial, employed feeder vessel coagulation using argon laser in one centre and xenon arc in the second centre. The follow-up period ranged from a mean of 21 to 32 months in one trial and 42 to 47 months in the second. Both trials were at risk of selection bias (random sequence generation) because of the randomisation method employed for participants with bilateral disease. One study was considered to be at risk of reporting bias.Using sectoral scatter laser photocoagulation, one trial (174 eyes) reported that complete regression of proliferative sickle retinopathy was seen in 30.2% in the laser group and 22.4% in the control group (no difference between groups). The same trial reported the development of new proliferative sickle retinopathy in 34.3% of laser-treated eyes and in 41.3% of eyes given no treatment; again, there was no difference between treatment groups. The second trial, using feeder vessel coagulation, did not present full data for either treatment group for these outcomes.There was evidence from both trials (341 eyes) that laser photocoagulation using scatter laser or feeder vessel coagulation may prevent the loss of vision in eyes with proliferative sickle retinopathy (at median follow up of 21 to 47 months). Data from both trials indicated that laser treatment prevented the occurrence of vitreous haemorrhage with both argon and xenon laser; with the protective effect being greater with feeder vessel laser treatment compared to scatter photocoagulation.Regarding adverse effects, the incidence of retinal tear was minimal, with only one event reported. Combined data from both trials were available for 341 eyes; there was no difference between the laser and control arms for retinal detachment. In relation to choroidal neovascularization, treatment with xenon arc was found to be associated with a significantly higher risk, but visual loss related to this complication is uncommon with long-term follow up of three years or more.Data regarding quality of life and other adverse effects were not reported in the included trials.
AUTHORS' CONCLUSIONS: Our conclusions are based on the data from two trials conducted over 20 years ago. In the absence of further evidence, laser treatment for sickle cell disease-related retinopathy should be considered as a one of therapeutic options for preventing visual loss and vitreous haemorrhage. However, it does not appear to have a significant different effect on other clinical outcomes such as regression of proliferative sickle retinopathy and development of new ones. No evidence is available assessing efficacy in relation to patient-important outcomes (such as quality of life or the loss of a driving licence). There is limited evidence on safety, overall, scatter argon laser photocoagulation is superior in terms of adverse effects, although feeder vessel coagulation has a better effect in preventing vitreous haemorrhage. Further research is needed to examine the safety of laser treatment compared to other interventions such as intravitreal injection of anti-vascular endothelial growth factors. In addition, patient-important outcomes as well as cost-effectiveness should be addressed.
镰状细胞病是一组遗传性血红蛋白病,可累及包括眼睛在内的多个器官。一些患者会因血管阻塞而出现眼部表现。镰状细胞病威胁视力的并发症主要是增殖性镰状视网膜病变,其特征是新生血管增殖。激光光凝广泛应用于增殖性视网膜病变,如增殖性镰状视网膜病变和增殖性糖尿病视网膜病变。评估激光光凝治疗增殖性镰状视网膜病变的疗效和安全性,对于预防威胁视力的并发症很重要。
评估各种激光光凝治疗技术对镰状细胞病相关性视网膜病变的有效性。
我们检索了Cochrane囊性纤维化和遗传疾病小组的血红蛋白病试验注册库,该注册库通过电子数据库检索以及对期刊和会议摘要书籍的手工检索编制而成。最后一次检索日期为2015年9月21日。我们还检索了以下资源(2015年3月24日):拉丁美洲和加勒比健康科学文献数据库(LILACS);世界卫生组织国际临床试验注册平台(ICTRP);以及ClinicalTrials.gov。
比较激光光凝与未治疗对儿童和成人疗效的随机对照试验。
两位作者独立评估试验的合格性、纳入试验的偏倚风险,并提取和分析数据。我们联系试验作者获取更多信息。
纳入了两项试验(238名儿童和成人的341只眼),比较激光光凝与未治疗对增殖性镰状视网膜病变患者的疗效和安全性。有121名男性和117名女性,年龄范围为13至67岁。两项试验中使用的激光光凝技术不同;一项单中心试验采用氩激光进行扇形散射激光光凝;另一项双中心试验,一个中心采用氩激光进行供养血管凝固,另一个中心采用氙弧光进行供养血管凝固。一项试验的随访期平均为21至32个月,另一项试验为42至47个月。由于对双侧疾病患者采用的随机化方法,两项试验均存在选择偏倚风险(随机序列生成)。一项研究被认为存在报告偏倚风险。采用扇形散射激光光凝,一项试验(174只眼)报告激光组增殖性镰状视网膜病变完全消退的比例为30.2%,对照组为22.4%(组间无差异)。同一试验报告激光治疗眼有34.3%出现新的增殖性镰状视网膜病变,未治疗眼为41.3%;同样,治疗组间无差异。第二项试验采用供养血管凝固,未提供这两个治疗组这些结局的完整数据。两项试验(341只眼)均有证据表明,采用散射激光或供养血管凝固进行激光光凝可预防增殖性镰状视网膜病变眼的视力丧失(中位随访期为21至47个月)。两项试验的数据均表明,激光治疗可预防氩激光和氙弧光引起的玻璃体积血;与散射光凝相比,供养血管激光治疗的保护作用更大。关于不良反应,视网膜裂孔的发生率极低,仅报告了1例。两项试验的合并数据涉及341只眼;激光组和对照组在视网膜脱离方面无差异。关于脉络膜新生血管,发现氙弧光治疗相关风险显著更高,但经过三年或更长时间的长期随访,与该并发症相关的视力丧失并不常见。纳入试验未报告生活质量和其他不良反应的数据。
我们的结论基于20多年前进行的两项试验的数据。在缺乏进一步证据的情况下,对于镰状细胞病相关性视网膜病变,激光治疗应被视为预防视力丧失和玻璃体积血的治疗选择之一。然而,它似乎对其他临床结局(如增殖性镰状视网膜病变的消退和新病变的发生)没有显著不同的影响。没有证据评估其对患者重要结局(如生活质量或驾照丧失)的疗效。总体而言,关于安全性的证据有限,散射氩激光光凝在不良反应方面更具优势,尽管供养血管凝固在预防玻璃体积血方面效果更好。需要进一步研究以检验与其他干预措施(如玻璃体内注射抗血管内皮生长因子)相比激光治疗的安全性。此外,应关注患者重要结局以及成本效益。