THE EFFICACY OF PRISM ADAPTATION IN ACQUIRED ESOTROPIA
THE EFFICACY OF PRISM ADAPTATION IN ACQUIRED ESOTROPIA
批准号:
3551397
负责人:
JOHN T FLYNN
金额:
$3.46万
依托单位国家:
美国
项目类别:
财政年份:
1984
资助国家:
美国
项目状态:
已结题
起止时间:
1984-05-01 至 1988-04-30
中文摘要
回顾研究表明,只有50%的外科患者患有
后天性内斜视通过一次手术达到良好的眼球对齐效果。新的
有证据表明,术前使用棱镜,好眼睛
在约85%的用户中,一次操作即可实现对齐
获得性内斜视手术患者。一个多中心的,随机的,
前瞻性、临床试验,认真注意标准化和
建议进行公正的结果评估,以确定:1.总体
比较(A)棱镜适形手术的有益效果
接受棱镜适应角手术的适应应答者,以及
棱镜适应无反应者对原角进行手术
偏向(B)那些没有棱镜适应和有
手术矫正原始斜角:2。患者是否存在斜视
获得性内斜视对棱镜适应的反应更准确
通过操作棱镜自适应角度或原始角度进行校正
偏差;3.患者对棱镜适应的反应是否通过
开发新的稳定斜角,具有更好的手术效果
对棱镜适应无反应的患者;以及4.是否
某些输入变量可用于预测哪些患者
可能从棱镜适应中受益。
为了回答这些问题,一项双重随机研究
都是精心设计的。五分之三的患者将被随机挑选出来
术前进行棱镜适配。五分之二的病人
将根据常规测量的交叉量进行手术
考试技巧。在那些对棱镜有反应的患者中,
一半的人将根据所需的棱镜数量进行手术
稳定偏差,而其余的将根据
最初测量的交叉量。
如果棱镜的适应确实带来了更成功的手术,它的采用可以
在实现减排的长期目标方面取得显著成效
获得性内斜视的治疗费用和发病率。
约2500例获得性内斜视的再手术
在美国的一年。如果可以通过以下方式减少三分之二
利用棱镜改编,每次手术费用在2000美元之间
和3,000美元(住院费+医疗费),总节省的美元将
每年在320万至480万美元之间。发病率将会
同样地减少了手术并发症
发生了,从学校或工作中损失的时间更少,而且相当少
给病人造成了心理创伤。
英文摘要
Retrospective studies indicate that only 50% of surgical patients with
acquired esotropia achieve good eye alignment with one surgery. New
evidence indicates that with the preoperative use of prisms, good eye
alignment can be achieved with one operation in approximately 85% of
surgical patients with acquired esotropia. A multicenter, randomized,
prospective, clinical trial with careful attention to standardization and
unbiased outcome evaluation is proposed to determine: 1. The overall
beneficial effect of the prism adaptation procedure by comparing (a) prism
adaptation responders who have surgery for the prism adapted angle, and
prism adaptation non-responders who have surgery for the original angle of
deviation to (b) those patients who do not have prism adaptation and have
surgery for the original angle of deviation: 2. Whether patients with
acquired esotropia, who respond to prism adaptation are more accurately
corrected by operating for the prism adapted angle or the original angle of
deviation; 3. Whether patients who respond to prism adaptation by
developing a new stable angle of deviation, have a better surgical result
than patients who do not respond to prism adaptation; and 4. Whether
certain input variables are useful in predicting which patients are more
likely to benefit from prism adaptation.
In an effort to answer these questions a double randomization study has
been designed. Three-fifths of the patients will be randomly selected to
go through prism adaptation prior to surgery. Two-fifths of the patients
will have surgery based on the amount of crossing measured using routine
examination techniques. Of those patients who respond to the prisms,
one-half will have surgery based on the amount of prism required to
stabilize the deviation while the rest will have surgery based on the
amount of crossing originally measured.
If prism adaptation does lead to more successful surgery, its adoption can
have a significant effect in meeting the long term objective of decreasing
the cost and morbidity for the treatment of acquired esotropia.
Approximately 2,500 reoperations for acquired esotropia are performed each
year in the United States. If these could be reduced by two-thirds through
utilization of prism adaptation, with each operation costing between $2,000
and $3,000 (hospital cost + physician's fee), the total dollar saving would
be between $3.2 million and $4.8 million per year. Morbidity would
likewise be reduced, with proportionally fewer operative complications
occurring, less time lost from school or work, and considerably less
psychological trauma to the patient.
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