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临床试验/CTRI/2025/02/080594
CTRI/2025/02/080594
尚未招募
不适用

Assessment of surgical outcome in patient with nondilating pupil undergoing phacoemulsification

Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年4月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha
入组人数
55
试验地点
1
主要终点
Postoperative improvement in Best Corrected Visual Acuity (BCVA), assessed using a Snellen chart or equivalent, and the reduction in postoperative complications such as glare and photophobia.

概览

简要总结

This prospective observational cohort study aims to evaluate the surgical outcomes in patients with non-dilating pupils undergoing phacoemulsification at a tertiary care hospital in Central India. The study focuses on comparing the efficacy and safety of three intraoperative techniques—stretch pupilloplasty/sphincterotomy, iris hooks, and pupillary expanders (B Hex Ring or GUPTA Ring)—in managing non-dilating pupils. Outcomes of interest include visual acuity improvement, postoperative complications, and overall surgical success, assessed at specific postoperative intervals. Findings are expected to provide evidence-based guidance for optimizing surgical strategies in such complex cases.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 40 years and above.
  • Patients diagnosed with cataracts.
  • Patients with non-dilating pupil.
  • Patients scheduled for phacoemulsification surgery.
  • Patients who provide written consent for participation in the study.

排除标准

  • Patients with traumatic Cataracts.
  • Patients with subluxated Cataracts.
  • Patients diagnosed with glaucoma.
  • Patients with complicated cataracts accompanied by uveitis or associated posterior segment issues.
  • Patients with a history of previous intraocular surgery.
  • Diabetic patients with existing diabetic retinopathy changes.
  • Patients with pre-existing retinal or macular diseases.
  • Patients unwilling to provide consent for participation in the study.

结局指标

主要结局

Postoperative improvement in Best Corrected Visual Acuity (BCVA), assessed using a Snellen chart or equivalent, and the reduction in postoperative complications such as glare and photophobia.

时间窗: Day 1, Week 1, and 1 Month Post-Surgery.

次要结局

  • Assessment of postoperative glare and photophobia, along with changes in intraocular pressure (IOP) and corneal status (e.g., edema or endothelial cell count).(Day 1, Week 1, and 1 Month Post-Surgery.)

研究者

发起方
Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Donthula Gayathri

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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