Augmented Medial Rectus Muscle Recession Versus Medial Rectus Recession With Posterior Scleral Fixation in Partially Accommodative Esotropia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success Rate
研究概览
简要总结
Prospective randomized interventional comparative study
详细描述
A prospective controlled interventional study will be performed on patients with partially accommodative esotropia. An informed consent for the surgery will be obtained from all patients. All patients' guardians will receive a thorough explanation of the study design and aims, and sign a written informed consent.
An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ 9. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group will be targeted
All patients will receive a full ophthalmological assessment including history taking, measurement of uncorrected and best-corrected visual acuity, cycloplegic refraction, anterior segment examination, as well as a dilated fundus examination.
In addition, all patients will have a detailed motor examination during the initial evaluation and at each follow-up period. The angle of misalignment will be measured by the prism and alternating cover tests for both distance and near with and without glasses. The angle of horizontal misalignment will also be measured in side gazes and in straight up and down gazes. Measurement of the angle of deviation in up and down gazes will be done by tilting the head, approximately 25 degrees down and up respectively, with the patient fixing on a distance target. The difference between the angles of horizontal misalignment in up and down gazes will be used to calculate the amount of pattern strabismus if present.
The ductions and versions in all cardinal directions of gaze will be analyzed before surgery and thereafter during the postoperative follow up visits. Underaction will be measured on a 4-point scale ranging from -1 to -4. Similarly overaction will be measured on a 4-point scale ranging from +1 to +4.
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired residual esotropia greater than 14 PD at distance fixation that exists despite full correction of hypermetropic refractive error with the angle of deviation for near not exceeding that of distance by more than 15 PD
- •Lack of previous extra ocular muscle surgery
排除标准
- •Fully accommodative esotropia, partially accommodative esotropia with convergence excess, non-accommodative esotropia or infantile esotropia
- •The presence of neurologic, developmental or ocular structural disorders
- •History of previous eye surgery
- •Patients requiring simultaneous oblique muscles surgery
- •Follow up less than 6 months
研究组 & 干预措施
Augmented recession
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
干预措施: augmented recession (Procedure)
Faden
Medial rectus muscle recession will be performed as described above with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
干预措施: Faden (Procedure)
结局指标
主要结局
Success Rate
时间窗: six months
Success rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.
次要结局
- Angle of Deviation Without Spectacles for Both Distance and Near(Six months)
- Angle of Deviation With Spectacles for Both Distance and Near(Six months)
- Angle Disparity(Six months)
- Surgery Time(Intraoperative time)
- Number of Patients Who Developed Intraoperative and/or Postoperative Complications(Six months)
研究者
Ahmed Awadein
Professor of Ophthalmology
Cairo University