Bockelbrink Angelina, Rasch Andrej, Roll Stephanie, Willich Stefan N, Greiner Wolfgang
Charité-Universitätsmedizin Berlin, Berlin, Deutschland.
GMS Health Technol Assess. 2006 Dec 12;2:Doc21.
The cataract (Cataracta senilis) is the most frequent eye disease of elderly people worldwide. In Germany, the cataract operation - with currently 450,000 interventions each year the most frequent operation in ophthalmology - can be seen as routine surgery. The age related macular degeneration (AMD) is a further one of the most common, age-related eye diseases and the most frequent cause of blindness of elderly people in industrial nations. Due to demographic changes an increasing number of patients will suffer from cataract and AMD at the same time. This coincidence leads to a greater interest in the question of a mutual influence of both diseases, respectively their therapies, on each other.
The aim of this report was the evaluation of the medical and health economic effects of cataract operations on the development and progression of an age related macular degeneration (AMD). It was differentiated between first manifestations of AMD, progression of early stages of AMD and influence on further impairment in late stages of AMD.
The relevant publications for this report were identified by DIMDI via structured database enquiry as well as common, self-made enquiry and were evaluated, based on the criteria of evidence based medicine. The present report included German and English literature published since 1983.
The database enquiry generated a record of 2769 issue-related publications. Eight medical publications were eligible for analysis in the course of the present HTA report. No relevant studies on health economical, ethical, social or legal issues could be included. Three epidemiological cohort studies provided some evidence for a promoting influence of cataract extractions on the progression of early types of AMD. Two of the epidemiological studies assessed the risk of first manifestation of AMD after cataract extraction. Both came up with up with increased incidences that did not reach statistical significance despite a large number of participants. Only one out of two clinical studies looked at further impairment in late stages of AMD and could not find an interrelation with cataract extraction. Thus the available evidence was not sufficient to come to a conclusion on the contribution of cataract extractions to the first manifestation of AMD and to the further impairment in late stages.
The presentation of the evaluated literature made clear that only a small number of publications dealt with the development of age related macula degeneration in consequence of a cataract extraction. The overall scientific level of evidence of these articles was not very high. Therefore it was not possible to obtain a well-defined conclusion on the effect of a cataract extraction on the development or progression of an age related macula degeneration.
Additional well conducted clinical trials, that offer a sufficient number of patients, length of study period and adequate control for confounding variables like age and severity of cataract, are urgently needed. Health economic, ethical, social and legal aspect of the problem could and should be investigated after clarification of the mentioned medical issues.
白内障是全球老年人中最常见的眼部疾病。在德国，白内障手术——目前每年有45万例干预措施，是眼科最常见的手术——可视为常规手术。年龄相关性黄斑变性（AMD）是另一种最常见的、与年龄相关的眼部疾病，也是工业化国家老年人失明的最常见原因。由于人口结构变化，越来越多的患者将同时患有白内障和AMD。这种巧合使得人们对这两种疾病及其治疗方法之间相互影响的问题产生了更大的兴趣。
本报告的目的是评估白内障手术对年龄相关性黄斑变性（AMD）的发生和发展的医学和卫生经济影响。区分了AMD的首次表现、AMD早期阶段的进展以及对AMD晚期进一步损害的影响。
DIMDI通过结构化数据库查询以及常规的自制查询确定了本报告的相关出版物，并根据循证医学标准进行了评估。本报告纳入了自1983年以来发表的德语和英语文献。
数据库查询产生了2769篇与问题相关的出版物记录。在本HTA报告过程中，有8篇医学出版物符合分析条件。未纳入关于卫生经济、伦理、社会或法律问题的相关研究。三项流行病学队列研究提供了一些证据，表明白内障摘除对早期AMD类型的进展有促进作用。两项流行病学研究评估了白内障摘除后AMD首次表现的风险。尽管参与者众多，但两者得出的发病率增加均未达到统计学意义。两项临床研究中只有一项研究了AMD晚期的进一步损害，未发现与白内障摘除有相关性。因此，现有证据不足以就白内障摘除对AMD首次表现和晚期进一步损害的影响得出结论。
所评估文献的呈现表明，只有少数出版物涉及白内障摘除导致的年龄相关性黄斑变性的发展。这些文章的总体科学证据水平不是很高。因此，不可能就白内障摘除对年龄相关性黄斑变性的发展或进展的影响得出明确结论。
迫切需要进行更多精心设计的临床试验，提供足够数量的患者、研究周期长度，并对年龄和白内障严重程度等混杂变量进行充分控制。在澄清上述医学问题后，可以而且应该研究该问题的卫生经济、伦理、社会和法律方面。
