Performance of EArly Retinal Laser (PEARL)

糖尿病是一种身体无法安全控制血糖的疾病，通常被认为是一种财富疾病。事实上，超过80%的糖尿病发生在贫穷或中等收入国家，这些国家的糖尿病发病率增长非常快。在中国，现在的糖尿病患者是30年前的10倍，发病率（12%）超过了美国。多年来，糖尿病损害眼睛的血管和视觉细胞，并可能导致失明。如果早期发现，大多数糖尿病失明可以通过激光预防，但中国农村只有10%的糖尿病患者接受治疗。一个主要原因是糖尿病性眼病（“DR”）的标准治疗要求患者返回检查，直到他们的眼睛达到称为“PDR”的晚期阶段，这可能需要许多年，然后才给予任何治疗。这对农村患者来说可能非常困难，他们往往受教育程度较低，较穷，这意味着他们在接受护理之前就辍学了。我们已经完成了对关于DR早期治疗的论文的回顾，在一个被称为“无PDR”或“NPDR”的阶段。“这项审查表明，需要研究来证明这种方法是安全和有益的，但证据表明，早期治疗可以更好地保护视力，并且对于那些可能会退出标准护理的患者来说更容易。为了填补证据上的差距，我们设计了一项研究，在该研究中，患有早期疾病的患者（“NPDR”，早期组）随机选择一只眼睛立即接受激光治疗，另一只眼睛只有在“PDR”发展较晚时才接受激光治疗，这是目前的标准。我们将比较在NPDR和PDR阶段治疗的眼睛的几个结果对患者很重要：视力，发展更严重的“PDR”疾病，和治疗对眼睛的损害。这项研究的一个重要目标是找出早期治疗的患者是否不太可能退出随访。由于患者的一只眼睛不能“退出”，我们还将有第二组人，只有在PDR发展时，他们的双眼才能接受后期治疗（“标准组”）。我们将比较早期和标准组之间的脱落率。早期治疗与标准治疗的成本也将被检查。将招募相同数量的城市和农村患者，因为我们的早期工作表明，农村患者由于缺乏对疾病的了解而面临特殊的辍学风险，但我们希望了解两种情况下的患者。我们的研究将有两个主要目标：1。这种研究，一种“审判”，是昂贵和艰难的。我们想先做一个小规模的“试点”（早期和标准组各100名患者，主试验各300名），以表明我们可以找到足够的患者，说服他们加入研究，给他们随机选择的治疗，随访1年并收集必要的数据。2.在丰富的环境中护理DR通常依赖于昂贵的测试或高级培训来定义需要进一步护理的治疗阶段（“NPDR”，“PDR”）和并发症。这种测试和培训在较贫穷的环境中可能不实用。在我们的研究中，训练有素的当地医生将使用简单，廉价的检查来确定阶段并发现并发症。我们将把他们的结果与更昂贵的测试和专家的照片分级进行比较，以了解这种更简单、更便宜的方法的效果如何。了解这些适合当地的方法是否有效对于贫困地区的糖尿病患者非常重要，这将是我们试点研究的重要组成部分。我们的团队包括中国和英国的糖尿病患者眼科护理，统计和试验专家。患者将在广州第一附属医院招募，该医院拥有中国最大的糖尿病诊所之一，并在中国最大的眼科医院中山眼科医院（ZOC）接受治疗。主要研究者Congdon教授是一名现居英国的眼科医生，他在中国ZOC工作多年，中文流利，将帮助联系团队

Diabetes, an illness in which the body cannot manage blood sugar safely, is often thought of as a disease of wealth. In fact, over 80% of diabetes occurs in poor or middle-income countries, where rates are growing very quickly. In China, there is ten times more diabetes now than there was 30 years ago, and rates (12%) exceed the US. Over years, diabetes damages blood vessels and vision cells in the eye, and can cause blindness. Most diabetic blindness can be prevented with laser if caught early, but only 10% of rural diabetic persons in China receive care. A major reason is that standard treatment of diabetic eye disease ("DR") calls for patients to return for examinations until their eyes reach a late stage called "PDR", which may take many years, before any treatment is given. This can be very difficult for rural patients, who are often less educated and poorer, meaning they drop out before receiving care.We have completed a review of papers written about earlier treatment of DR, at a stage called "No PDR" or "NPDR." This review showed studies are needed to prove that this approach is safe and beneficial, but evidence suggests that early treatment could be better to preserve vision, and easier for patients who might otherwise drop out of standard care. To fill the gap in evidence, we designed a study where patients with disease at an earlier stage ("NPDR," the Early Group) get laser treatment right away in one eye chosen by chance and the other eye only get laser if "PDR" develops later, which is the current standard. We will compare eyes treated at NPDR and PDR stages for several outcomes important to patients: vision, developing more serious "PDR" disease, and damage to the eye from treatment. An important goal of this study is to find out if patients who get early treatment are less likely to drop out of follow-up. Since one eye of a patient can't "drop out," we will also have a second group of people who will get later treatment in both eyes only if PDR develops ("Standard Group"). We will compare the rate of dropout between the Early and Standard group. The cost of Early versus Standard treatment will also be examined.An equal number of urban and rural patients will be recruited, because our early work shows that rural patient are at special risk for dropping out, because of their lack of understanding of their disease, but we want to understand patients from both settings. Our study will have two main aims:1. This kind of study, a "trial," is expensive and hard. We want to first do a small "Pilot" (100 patients each in Early and Standard groups, versus 300 in each for the main trial) to show that we can find enough patients, convince them to join the study, give them the treatment as selected by chance, follow them for 1 year and collect necessary data.2. Care of DR in rich settings often depends on expensive tests or advanced training to define the stages ("NPDR," "PDR") and complications of treatment that require further care. Such tests and training may not be practical in poorer settings. In our study, trained local doctors will define stages and find complications using simple, cheap examinations. We will compare their results against more expensive tests and photo grading by experts to find out how well this simpler and cheaper approach works. Finding out if these locally appropriate ways work is very important for diabetic eye are in poorer areas, and will be an important part of our Pilot study.Our team includes Chinese and UK experts in diabetic eye care, statistics and trials such as this one. Patients will be recruited at the First Affiliated Hospital in Guangzhou, which has one of the largest diabetic clinics in China, and treated at Zhongshan Ophthalmic Hospital (ZOC), China's largest eye hospital. The main investigator, Prof Congdon, is an eye doctor based now in the UK, who has worked in China at ZOC for many years, is fluent in Chinese, and will help to link teams