Cataract surgery with associated coloboma: predictors of outcome and safety of different surgical techniques
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Improved postoperative visual outcomes and reduced surgical complications
研究概览
简要总结
Coloboma, a congenital defect due to incomplete embryonal fissure closure, often affects the infero-nasal part of the fundus & is frequently associated with cataracts, a leading treatable cause of visual impairment. However, cataract surgery in colobomatous eyes presents significant challenges due to anatomical anomalies such as microcornea, zonular instability, poor pupillary dilation, & structural irregularities. This hospital-based observational study, done at Ophthalmology Department Acharya Vinobha Bhave Rural Hospital, Sawangi, over two years aiming to evaluate the outcomes & safety of cataract surgery techniques, including phacoemulsification (PE) & manual small incision cataract surgery (M-SICS). The surgery type will depend on the degree of microcornea, cataract hardness, & zonular stability. Preoperative, intraoperative, & postoperative assessments will include detailed ophthalmic evaluations, visual acuity measurements, grading of microcornea, & complications such as corneal edema, using standardized grading systems. Statistical analysis using SPSS will identify predictors of surgical outcomes, with significance at p < 0.05. The study seeks to improve surgical techniques, enhance patient safety, & provide insights into counselling & risk stratification for individuals with coloboma-associated cataracts. By considering these challenges, the study aims to optimize functional outcomes & quality of life for affected patients. The study is expected to demonstrate improved postoperative visual outcomes, reduced surgical complications, & enhanced safety in cataract surgery for colobomatous eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with coloboma and having cataract
- •Patients with no history of previous ocular surgery in operating eye.
排除标准
- •Patients having other ocular comorbidities injuries or surgery
- •Cases with premature entry or where valve could not be formed properly.
结局指标
主要结局
Improved postoperative visual outcomes and reduced surgical complications
时间窗: Assessment will be made at postoperative six weeks
次要结局
未报告次要终点
研究者
Dr Ashish Sharma
Datta Meghe Institute of Higher Education and Research
