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临床试验/NCT00000170
NCT00000170已完成3 期

Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

Jaeb Center for Health Research1 个研究点 分布在 1 个国家目标入组 419 人开始时间: 1999年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
419
试验地点
1
主要终点
Visual acuity in the amblyopic eye

研究概览

简要总结

  • To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy
  • To develop more precise estimates of the success rates of amblyopia treatment
  • To identify factors that may be associated with successful treatment of amblyopia
  • To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available

Extended Follow up of Study Patients

  • Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
  • Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

详细描述

Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often persists in adulthood. It is reported to be the leading cause of vision loss in one eye in the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating that both improved means of detection and treatment are needed.

Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled. Despite the common occurrence of amblyopia, there is little quality data on treatment of this condition. Thus, there is much to be learned about the course of treated amblyopia, to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment.

Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the sound eye. Occlusion therapy is subject to problems of compliance, due to the child's dislike of wearing a patch for visual, skin irritation, and social/psychological reasons. There is evidence that compliance may be one of, if not, the most important determinant of success of amblyopia therapy.

An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the pupils and blurs the image seen by the sound eye, has been known for almost a century. This method has been widely used for the management of occlusion treatment failures and for maintenance therapy. However, it has seen little use as a primary treatment for amblyopia. Clinical experience has found that it has a high acceptability to patients and parents, and hence high compliance. In addition to its acceptability, pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes, which may have safety and other functional implications. There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes (binocularity).

Available data suggest that the success rate with drug therapy is as good as, if not better than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If this is true, for many children with amblyopia, drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents. Despite data to support the use of drug therapy as a primary therapy for amblyopia, it has gained only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
  • Visual acuity in the amblyopic eye must be between 20/40 and 20/100
  • Visual acuity in the sound eye or 20/40 or better
  • At least 3 lines of acuity difference between the two eyes

排除标准

  • More than two months of amblyopia therapy in the past two years
  • Myopia (more than -0.50 D)

研究组 & 干预措施

Patching

Active Comparator

干预措施: Eye Patch (Device)

Atropine

Active Comparator

Atropine

干预措施: Atropine (Drug)

结局指标

主要结局

Visual acuity in the amblyopic eye

时间窗: 6 months

次要结局

  • Visual acuity in the amblyopic eye(24 months)
  • Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years(age 10 years and age 15 years)
  • Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care(age 10 years and age 15 years)

研究者

发起方
Jaeb Center for Health Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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