Prism Adaptation in Symptomatic Esophoria - Effect of Shorter Time Intervals and Surgical Outcomes Based on Prism Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reoperation rate
研究概览
简要总结
This study is a prospective randomized study aiming to investigate the effect of prism adaptation before surgery for symptomatic esophoria on the number of reoperations, the occurrence of over- and under-correction after the first surgery, and symptom resolution. Additionally, we aim to define the optimal duration of prism adaptation.
详细描述
SUBSTUDY 1 The Optimal Duration of Prism Adaptation in Symptomatic Esophoria Study Design: Prospective, randomized controlled study Patient Group: 100 participants with symptomatic esophoria, randomized into two groups of 50 participants each to undergo either one hour or four hours of prism adaptation.
The purpose of this study is to determine the optimal duration of prism adaptation.
The hypothesis is that the measured deviation angle is expected to increase after one hour of prism adaptation compared to before prism adaptation. Furthermore, it is expected that the measured deviation angle will not differ significantly between the two randomization groups. The primary endpoint is the measured deviation angle at the conclusion of prism adaptation.
The results are highly relevant for accurate surgical dosing (and thus postoperative symptoms and reoperation rates), efficient use of hospital resources, and reduced patient waiting times in the outpatient clinic.
SUBSTUDY 2 Strabismus Surgery for Symptomatic Esophoria Based on Prism Adaptation Study Design: Prospective, randomized controlled study Patient Group: 100 participants with symptomatic esophoria, using the same patients and randomization groups as in Substudy 1.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic esophoria who meet one or more of the following criteria:
- •Double vision
- •Asthenopia (eye strain)
- •Headaches related to esophoria
- •Worsening of symptoms during fatigue, sleep deprivation, reading, illness, or alcohol consumption.
排除标准
- •Age between 18 and 65 years at date of inclusion.
- •Accommodative esotropia or esophoria
- •Myopia exceeding 10 diopters in the most myopic meridian
- •Treatment with botulinum toxin in an eye muscle within four months prior to inclusion
- •Inability to undergo reliable orthoptic measurements or prism adaptation
- •Previous strabismus surgery
- •Pregnancy or breastfeeding within 12 months prior to inclusion
- •Myogenic disorders (including Myasthenia Gravis)
- •Restrictive strabismus (including previous eye muscle trauma or Graves' orbitopathy)
- •Eye muscle paresis
- •Maximum prism-adapted deviation angle >40 prism diopters (PD) in any gaze direction for distance
- •Maximum prism-adapted deviation angle with ≥20 PD difference between near and distance measurements
结局指标
主要结局
Reoperation rate
时间窗: Up to 5 years
Number of patients in need of reoperation after initial surgery for symptomatic esophoria
Measured deviation angle at the conclusion of prism adaptation.
时间窗: Up to 5 years
Measured deviation angle in prism diopters at the conclusion of prism adaptation.
次要结局
- Motor success(1 year from date of surgery)
- Sensory success(1 year from date of surgery)
- Symptomatic success(1 year from date of surgery)
研究者
Mikael Hofsli
Principal investigator
Rigshospitalet, Denmark