跳至主要内容
临床试验/CTRI/2022/12/048248
CTRI/2022/12/048248尚未招募不适用

REFRACTIVE OUTCOME OF CILIARY SULCUS IMPLANTED INTRAOCULAR LENSES

SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年12月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
77
试验地点
1
主要终点
To determine the difference in the preoperative predicted and postoperative spherical equivalent refraction for each patient - “Refractive shiftâ€

研究概览

简要总结

This prospective interventional study will be conducted on minimum of 77 patients fulfilling the inclusion criteria in the department of Ophthalmology, R. L. Jalappa Hospital and Research, Kolar from August 2022 to December 2023, after obtaining ethical clearance from Institutional Ethical Committee of Sri Devaraj Urs Academy of Higher Education and Research and written informed consent from the participants. The primary outcome of this study will be to determine the difference in the preoperative predicted and postoperative spherical equivalent refraction for each patient - “Refractive shiftâ€. The secondary outcomes will be to determine the difference in the IOL power for in the bag implantation and for the IOL implanted in the ciliary sulcus and to document the intra operative and postoperative complications

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Capsule rupture: a) Anterior capsular tear without extension b)Anterior capsular tear extending to posterior capsule c) Posterior capsular tear with intact anterior capsule
  • Zonular dehiscence
  • Weak zonules in case of pseudoexfoliation
  • Traumatic subluxation of lens.

排除标准

  • Lack of Anterior Capsular Support
  • Patients on any topical IOP-lowering drugs like Timolol.
  • Patients with lacrimal gland and drainage disorder.
  • Patients with diabetes mellitus.
  • Thyroid disease patients.

结局指标

主要结局

To determine the difference in the preoperative predicted and postoperative spherical equivalent refraction for each patient - “Refractive shiftâ€

时间窗: To determine the difference in the preoperative predicted and postoperative spherical equivalent refraction for each patient at day 1, day 7 and after 1 month postoperatively.

次要结局

  • 1. To determine the difference in the IOL power for in the bag implantation and for the IOL implanted in the ciliary sulcus(2. To document any intraoperative and postoperative complications)

研究者

申办方类型
Private medical college

研究点 (1)

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