Risk Factors And Surgical Outcomes Of Strabismus Reoperation: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Rate Of Surgical Success After Horizontal Strabismus Reoperation
研究概览
简要总结
Horizontal strabismus, commonly known as inward or outward deviation of the eyes, is a frequent eye condition that may require surgical correction. Although the first surgery is often successful, some patients develop residual or recurrent eye misalignment and require a second operation (reoperation).
This study aims to identify the clinical and surgical factors that may increase the risk of undercorrection, overcorrection, or recurrence after the first surgery. It also evaluates the outcomes and success rate of repeat surgery in patients with horizontal strabismus.
Patients undergoing reoperation will receive a complete ophthalmological examination before surgery. The surgical plan will be individualized based on previous surgical history and current eye findings. All procedures will be performed under general anesthesia by the same surgeon. Participants will be followed for three months after surgery to assess eye alignment, movement, and possible complications.
The results of this study may help improve surgical planning and predict which patients are at higher risk of requiring additional surgery in the future.
详细描述
Horizontal strabismus, including esotropia and exotropia, represents the most common form of ocular misalignment requiring surgical intervention. Despite advances in surgical techniques, a proportion of patients experience residual deviation, overcorrection, or recurrence after primary surgery, necessitating reoperation. Reoperation presents unique surgical challenges due to altered anatomy, scar tissue formation, possible muscle slippage, and variability in postoperative healing response.
Reported reoperation rates vary across studies and clinical settings, with multiple patient-related and surgical factors implicated in surgical failure. These factors may include age at primary surgery, magnitude of deviation, amblyopia, number of operated muscles, surgical technique, and time interval between surgeries. However, data regarding predictive risk factors and standardized outcome evaluation in reoperated horizontal strabismus remain limited in the local setting.
This prospective interventional study will be conducted at Assiut University Hospital. It will include patients undergoing repeat surgery for correction of horizontal strabismus. Patients with vertical deviations, paralytic or restrictive strabismus, neurological or syndromic associations, or incomplete previous surgical data will be excluded.
Preoperative assessment will include measurement of visual acuity, cycloplegic refraction, anterior and posterior segment examination, evaluation of ocular motility in nine diagnostic positions of gaze, and measurement of angle of deviation using prism and alternate cover test or Krimsky test when appropriate. Documentation of conjunctival scarring and previous surgical details will be performed.
The surgical approach will be individualized according to preoperative findings and prior operative records. Exploration of previously operated muscles will be performed when clinically indicated. Intraoperative forced duction testing will assess muscle tightness. All surgeries will be conducted under general anesthesia by the same surgeon to reduce inter-operator variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with horizontal strabismus (esotropia or exotropia).
- •Patients undergoing repeat surgery for correction of residual, recurrent, undercorrected, or overcorrected horizontal strabismus.
- •Availability of sufficient medical records documenting previous strabismus surgery.
- •Ability to attend scheduled postoperative follow-up visits.
- •Written informed consent obtained from the patient or legal guardian.
排除标准
- •Combined vertical and horizontal strabismus.
- •Paralytic strabismus.
- •Restrictive strabismus.
- •Strabismus associated with neurological or syndromic conditions.
- •Patients with incomplete or insufficient documentation of previous surgical procedures.
- •Patients unwilling or unable to complete follow-up.
研究组 & 干预措施
Horizontal Strabismus Reoperation
All enrolled participants undergo repeat surgery for correction of horizontal strabismus (esotropia or exotropia). The surgical approach is individualized based on preoperative clinical evaluation and prior operative records. Exploration of previously operated muscles is performed when indicated, particularly in cases of limited ocular motility or suspected scarring. Otherwise, surgery is performed on unoperated horizontal rectus muscles when appropriate. Intraoperative forced duction testing is conducted to assess muscle tightness, and scar tissue release is performed if necessary. All procedures are performed under general anesthesia by the same surgeon. Participants are followed postoperatively to evaluate alignment, ocular motility, and surgical outcomes.
干预措施: Horizontal Strabismus Reoperation (Procedure)
结局指标
主要结局
Rate Of Surgical Success After Horizontal Strabismus Reoperation
时间窗: 3 months postoperative
Percentage of participants achieving postoperative ocular alignment within ±10 prism diopters of orthotropia measured using the Prism and Alternate Cover Test at distance fixation.
次要结局
- Preoperative Angle Of Deviation(Baseline (preoperative))
- Age At Primary Strabismus Surgery(Baseline)
- Presence Of Amblyopia(Baseline)
- Number Of Extraocular Muscles Operated During Reoperation(Intraoperative)
研究者
Rehab Safwat Hamza
Resident at Department of Ophthalmology, Assiut University Hospital
Assiut University