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临床试验/CTRI/2024/06/068809
CTRI/2024/06/068809已完成不适用

Comparison Of Clinical Outcomes Of Computer Assisted And Smartphone Based Target Axis Alignment For Toric Intra Ocular Lens Implantation

Dr Arya S S1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
To measure angular deviation IOL alignment of computer aided axis mark from the target axis vs angular deviation of IOL alignment of smartphone-assisted mark from the target axis, compare the best corrected visual acuity and postoperative residual astigmatism

研究概览

简要总结

This is an Observational randomized parallel group trial to study and compare the clinical outcomes of Computer assisted and Smartphone based target axis marking for the implantation of a toric intra ocular lens during cataract surgery for patients with regular corneal astigmatism of more than 1.2 DCYL, which will be conducted at Base hospital, Department of Ophthalmology ( teritiary care hospital ) in India. The primary outcome is to measure the final axis deviation of Toric IOL from the calculated axis with the above said methods of axis marking. The secondary outcome is to measure and compare the best corrected visual acuity and postoperative residual astigmatism in both cases.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients above 18 years and below 80 years 2.Diagnosed with cataract and planned to undergo phacoemulsification and toric monofocal IOL implantation.
  • 3.Patients having regular corneal astigmatism of more than 1.2 and axial length between 22mm and 23.5mm.

排除标准

  • 1.Irregular corneal astigmatism 2.Previous intraocular or corneal surgeries 3.Intraoperative complications compromising toric IOL position such as zonular damage, vitreous loss, capsulorrhexis tear, posterior capsular rupture or any condition which could interfere with the visual outcome 4.Those with the postoperative findings of high myopia, glaucoma, retinal disease, postoperative miosis, prolonged postoperative iritis, etc.

结局指标

主要结局

To measure angular deviation IOL alignment of computer aided axis mark from the target axis vs angular deviation of IOL alignment of smartphone-assisted mark from the target axis, compare the best corrected visual acuity and postoperative residual astigmatism

时间窗: Postop day 1, 7 and 30

次要结局

  • comparison of best corrected visual acuity (BCVA) and postoperative residual astigmatism.(Postop day 1, 7 and 30)

研究者

发起方
Dr Arya S S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Arya S S

Base Hospital, Delhi Cantt

研究点 (1)

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