A Randomized Clinical Trial of Part-time Patching Therapy on Improvement of Deviation Control in 3 to 8 Year-old Children With Intermittent Exotropia
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 主要终点
- 6-point scale Deviation Control
研究概览
简要总结
Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. According to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
care provider, investigator and outcome assessor will be unaware the group of participants. because of the nature of study, patch therapy vs no treatment, masking of participant will not be possible.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria
排除标准
- •No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations
- •Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction
- •History of previous treatments including eye occlusion, minus therapy, and strabismus surgery
- •Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
研究组 & 干预措施
patch therapy
The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week.
干预措施: patch therapy (Other)
Control
no intervention will be done
结局指标
主要结局
6-point scale Deviation Control
时间窗: 3 months after treatment
the ability of the child to control his/her deviation at far and near was assessed based on the office control 6-point scale: Children are classified according to the office control 6-point scale into six groups of 0 to 5. In this classification, exotropia is ranked after 30 seconds of observation: constant exotropia is ranked 5th, exotropia in more than 50% of the observing time is ranked 4th, and exotropia in less than 50% of the observing time is ranked 3rd. If exotropia is not seen in 30 seconds, the classification is made based on the speed of deviation control and fusion return 10 seconds after covering the eyes: back of fusion in more than 5 seconds is ranked 2nd, fusion return between 1 and 5 seconds ranked 1st, and fusion return in less than 1 second is ranked 0.
3-point scale Deviation Control
时间窗: 6 months after treatent
the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
次要结局
- Near stereopsis(at the time of enrollment, 3 month later and 6 month later)
- Fusion(at the time of enrollment, 3 month later and 6 month later)