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临床试验/CTRI/2024/05/067597
CTRI/2024/05/067597尚未招募Phase 3 4

Comparative study regarding the anatomical and functional recovery of eye and patient satisfaction score after small incision cataract surgery and topical phacoemulsification cataract surgery

Acharya Vinoba Bhave Rural Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年6月13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
110
试验地点
1
主要终点
1. Corneal Astigmatism

研究概览

简要总结

This study is being conducted to evaluate astigmatism through vertical and horizontal keratometry readings, Tear film function through Schirmer’s test 1 and central macular thickness through optical coherence tomography (OCT) pre- operatively & post- operatively in small incision cataract surgery & phacoemulsification under topical anaesthesia.

Following consideration of the standards for inclusion and exclusion, the subjects for the case group study will go through an ophthalmological examination that includes detailed history pertaining to symptoms was recorded–onset, duration and, any aggravating factors, a routine general physical examination, a detailed ophthalmic examination including external eye examination, Visual acuity (both distance & near vision), Slit lamp examination to visualize the eye’s anterior segment and fundus examination. The patients are categorised under 2 groups- Patients undergoing SICS and Patients undergoing Phacoemulsification under topical anaesthesia. Post operatively, patients would be given an Antibiotic, an analgesic and a proton pump inhibitor tablet for 3 days. Eye drop 0.5% Moxifloxacin + 1% Prednisolone, eye drop Nepafenac 0.1% & eye drop 2% Homatropine would be given for 15 days.  Patient follow up would be conducted on post operative day 1, day 15, day 30 & on day 60.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • Patients with uncomplicated, unilateral, or bilateral, immature senile cataracts of grade III or less Patients from whom consent has been obtained.

排除标准

  • Grade 4–5 cataracts 2.Mature, hyper-mature, complicated, genetic, and traumatic cataract 3.Patients with immature cataracts who also have other ocular comorbidities, have had eye trauma, or have undergone eye surgery.
  • 4.Patients who suffer from any systemic diseases, like diabetes mellitus and raised blood pressure 5.Those who did not give consent.

结局指标

主要结局

1. Corneal Astigmatism

时间窗: Day1, Day15, Day 30, Day 60

2. Visual Acquity

时间窗: Day1, Day15, Day 30, Day 60

3. Tear film function test

时间窗: Day1, Day15, Day 30, Day 60

4. Central Macular Thickness

时间窗: Day1, Day15, Day 30, Day 60

次要结局

  • Post Surgical Inflammation, Endophthalmitis, Pseudophakic Bullous Keratopathy and Other Complications after surgery Procedure.(At day 30 & Day 60)

研究者

发起方
Acharya Vinoba Bhave Rural Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Zoya Javed

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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