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临床试验/NCT07103473
NCT07103473尚未招募不适用

Interactive Binocular Treatment (I- BiT) in Adult Patients With Anisometropic Amblyopia

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年12月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
2
主要终点
Best corrected visual acuity

研究概览

简要总结

Amblyopia is one of the common, preventable and treatable causes of decreased acuity of one or both eyes without a specific organic cause. Common treatments include optical correction, patching (closing the healthy eye), perceptual learning, and drug treatments. The patient's low cooperation, reduction in effectiveness and long treatment period of common methods have led to the design of new treatments that eliminate these disadvantages, among which binocular vision treatments can be mentioned. The purpose of this study is to apply a new and innovative method under binocular conditions in the treatment of anisometropic amblyopia in adults. In this randomized clinical trial study, 30 people (15 patients in the case group and 15 patients in the control group) aged 18 to 40 years with amblyopia (decrease in best corrected vision worse than 0.3 logarithmic units in one of the eyes or the difference of the corrected minimum visual acuity of two lines between two eyes) in the form of two groups of 15 people (case and control) will be included in the study. Patients will be randomly divided into two groups: case and control. Interactive Binocular Treatment (I-BiT) is used in the case group and usual games without I-BiT system are used as placebo in the other group. For this purpose, the games will be presented in the control group in such a way that the two eyes will not be dissociated and the patient will see all the targets in the same way with his two eyes. I-BiT is a new method for the treatment of amblyopia in which a person plays age-appropriate games using special glasses in a 3D space. The stimuli are shown differently to the two eyes and both eyes are involved in the treatment process. The selection of people in two groups will be such that background variables such as age, sex, as well as the severity of amblyopia or vision loss in the two groups are the same and confounding factors are under control. First, all eye examinations such as measuring visual acuity, lateral vision, checking refractive errors with and without cycloplegic drops, checking the alignment of visual axes, and also checking the anterior and posterior segments of the eye are performed. After the definitive diagnosis of amblyopia, people in both groups will be asked to use the given virtual games in the same way for one month, 5 sessions per week, each session for 30 minutes. In order to control the amount of use of computer games by patients, the duration of time that people use games will be controlled and recorded online using software by design engineers. Patients will be examined before treatment, one month after treatment and also one month after stopping treatment.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range from 18 to 40 years
  • Best corrected visual acuity of 0.3 log units or worse in one eye
  • Cases of mild and moderate anisometropic amblyopia (BCVA≤0.3)

排除标准

  • 未提供

结局指标

主要结局

Best corrected visual acuity

时间窗: one month

The changes of the best corrected visual acuity after one month therapy will be measured as the primary outcome measure.

Best corrected visual acuity

时间窗: one month

The changes of the best corrected visual acuity after one month therapy will be measured as the primary outcome measure.

次要结局

  • Stereopsis(one month)
  • Stereopsis(one month)

研究者

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

Hamideh Sabbaghi

Assistant Professor

Shahid Beheshti University of Medical Sciences

研究点 (2)

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