Comparative study regarding the anatomical and functional recovery of eye and patient satisfaction score after small incision cataract surgery and topical phacoemulsification cataract surgery
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
Dr Zoya Javed
Datta Meghe Institute of Higher Education and Research
