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临床试验/NCT03610997
NCT03610997终止不适用

Photorefractive Keratectomy for Anisometropic and Isoametropic Amblyopia in Children Refractory to Conventional Treatment

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
2
主要终点
Visual acuity

研究概览

简要总结

Photorefractive keratectomy (PRK) with excimer laser has been used successfully to treat myopia, hyperopia, and astigmatism in adults for over 35 years. Children with high refractive errors that go untreated will develop severe amblyopia. PRK can normalize high refractive errors and potentially improve the visual acuity in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity.

详细描述

Anisometropia is a condition in which one eye has a significantly different refractive error from the other and commonly leads to the development of refractive amblyopia in the affected eye. High isoametropia is the condition in which both eyes have high refractive error and commonly leads to bilateral refractive amblyopia if untreated. Amblyopia is the condition in which vision does not develop fully in the brain due to disuse or misuse of one or both eyes. Typically, in high anisometropia, a contact lens in the eye with the stronger refractive error and/or glasses must be used to correct the refractive error. Commonly, infants and children with this condition refuse to wear the contact lens or glasses because the other eye sees normally. There are other problems in treating high anisometropia with glasses. One is aniseikonia, the condition of image size disparity between the two eyes. This causes difficulty for the brain of the affected person to fuse the images from the two eyes because the image from one eye is much larger than that from the other eye. This results in asthenopia (eye fatigue) and sometimes even diplopia. If the anisometropia is severe, significant amblyopia will result in the eye with the stronger refractive error and, if not treated at an early age, permanent and potentially severe vision loss will result.

In high isoametropia, contact lenses or glasses must likewise be used in order for normal vision to develop. Most children with isoametropia will wear glasses well because they cannot see well without them. By contrast, children with developmental delays, chromosomal abnormalities, autism, or attention deficit hyperactivity disorder and high isoametropia very commonly will not wear the needed refractive correction due to strong tactile aversion to anything touching their face or head. If the refractive error is high, significant bilateral (isoametropic) amblyopia will result and, if not treated at an early age, permanent and potentially severe vision loss will result.

PRK can normalize high refractive errors and potentially reduce or eliminate the amblyopia in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity. Secondary outcomes are stability of refractive correction, and corneal health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months.
  • Anisometropic group:
  • The anisometropia must be at least 3.00 diopters.
  • The amblyopic eye best corrected visual acuity must be at least 2 lines worse than the fellow eye in verbal children
  • Isoametropic group
  • Myopia must be at least -4.00 diopters in both eyes
  • Hyperopia must be at least +4.00 diopters in both eyes
  • Astigmatism must be at least +2.50 diopters in both eyes.

排除标准

  • History of significant corneal abnormality that, in the investigator's opinion, may limit visual rehabilitation.
  • History of known collagen disorder
  • History of known corneal ectasia
  • History of previous herpes simplex keratitis
  • Corneal thickness of less than 450u

结局指标

主要结局

Visual acuity

时间窗: 10 years

Snellen equivalent

次要结局

  • Corneal clarity(10 years)
  • Refractive error(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evelyn Paysse

Professor of Ophthalmology and Pediatrics

Baylor College of Medicine

研究点 (2)

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