跳至主要内容
临床试验/CTRI/2025/05/087449
CTRI/2025/05/087449尚未招募Phase 3 4

Cataract surgery with associated coloboma: predictors of outcome and safety of different surgical techniques

Datta Meghe Institute Of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年6月15日最近更新:

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

发起方
Datta Meghe Institute Of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ashish Sharma

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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