跳至主要内容
临床试验/NCT03655912
NCT03655912招募中不适用

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Universidad Autonoma de Nuevo Leon2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Best corrected visual acuity of the amblyopic eye

研究概览

简要总结

Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and/or movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.

详细描述

The objective of this study is to determine if the binocular visual therapy with red-green glasses and the use of electronic devices is effective for amblyopia treatment in children.

Participants will be randomly assigned to one of three treatment modalities: Group A: eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc) Group B: an eye patch on the fellow eye and a electronic tablet Group C: red/green glasses and a electronic tablet

Treatment will be done buy the three groups daily during 2 consecutive hours, and will be completed for four months. Children will then suspend the therapy for 2 months, and will be reevaluated to determine lazy eye relapses . All groups will be compared to see which patients achieved greater improvement on visual acuity and depth perception.

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
Double (Participant, Care Provider)

盲法说明

Neither the patient or the care provider will be aware of the treatment modality group the patient is in. In order to achieve that, patients in different modality groups will be evaluated in different days preventing information of group modality gossip between the patients parents.

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with anisometropic amblyopia, strabismic amblyopia or both
  • Patients with out previous amblyopia treatment
  • Patient with previous strabismus surgery or use of there best corrected visual acuity glasses for at least 1 month
  • Birth at term gestational age
  • Without any systemic or ophthalmic comorbidities
  • Previous patients parent verbal and fiscal assessment.

排除标准

  • Any other amblyopia diagnosis (deprivation)
  • Any previous amblyopia treatment
  • Any previous intraocular surgery
  • Any ocular condition
  • Any neurologic conditions or psychomotor development alterations
  • Patients not able to cooperate for visual acuity or stereopsis evaluation

研究组 & 干预措施

Patch

Active Comparator

Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc)

干预措施: Eye patch (Device)

Electronic Devices

Experimental

Eye patch on the fellow eye and a electronic tablet

干预措施: Electronic Tablet (Device)

Red/Green Glasses

Experimental

Red/green glasses and a electronic tablet

干预措施: Red/green glasses (Device)

结局指标

主要结局

Best corrected visual acuity of the amblyopic eye

时间窗: Four months of treatment

Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

Best corrected visual acuity of the amblyopic eye two months after treatment suspension to determine lazy eye relapses

时间窗: Two months after treatment suspension.

Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

Best corrected visual acuity of the amblyopic eye

时间窗: Basal

Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

Best corrected visual acuity of the amblyopic eye

时间窗: One month of treatment

Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

Best corrected visual acuity of the amblyopic eye

时间窗: Two months of treatment

Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

Best corrected visual acuity of the amblyopic eye

时间窗: Three months of treatment

Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

次要结局

  • Stereopsis two months after treatment suspension to determine lazy eye relapses(Two months after treatment suspension.)
  • Stereopsis(Four months of treatment)
  • Stereopsis(One month of treatment)
  • Stereopsis(Basal)
  • Stereopsis(Two months of treatment)
  • Stereopsis(Three months of treatment)

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karim Mohamed-Noriega

Professor

Universidad Autonoma de Nuevo Leon

研究点 (2)

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