跳至主要内容
临床试验/CTRI/2024/07/069852
CTRI/2024/07/069852招募中4 期

COMPARATIVE STUDY TO SEE THE EFFECT OF INTRACAMERAL MYDRIATICS VERSUS TOPICAL MYDRIATICS IN PUPIL DILATATION FOR PHACOEMULSIFICATION CATARACT SURGERY

Shivi Srivastava1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Pupil size in front of the slit lamp and by surgical callipers 3 times during the procedure

研究概览

简要总结

Traditional methods of achieving optimal pupil dilatation during phacoemulsification rely on topical mydriatics, such as tropicamide 0.8% and phenylephrine 5%. However, the emergence of intracameral mydriatics, specifically a fixed-dose combination (FDC) comprising tropicamide 0.2%, phenylephrine 2%, and preservative-free lidocaine 1%, presents a promising alternative. The existing literature acknowledges the advantages of intracameral mydriatics, including potentially faster onset, prolonged duration of action, and reduced dependence on patient compliance. However, the majority of studies and safety data primarily pertain to populations outside the Indian subcontinent. Given the unique characteristics of the Indian demographic, such as varied genetic predispositions and environmental factors, there is a compelling need to assess the safety and efficacy of intracameral mydriatics specifically within this population. This study aims to address this critical gap in knowledge by conducting a comprehensive comparative analysis of the effects of intracameral mydriatics versus topical mydriatics in achieving pupil dilatation for phacoemulsification cataract surgery. By meticulously evaluating parameters such as speed, extent, and sustainability of pupil dilation, as well as monitoring potential adverse events, the study seeks to provide valuable insights into the appropriateness of intracameral mydriatics within the Indian context. Ultimately, the findings are expected to inform clinical practice, optimize surgical outcomes, and contribute to the ongoing refinement of cataract surgery protocols in the pursuit of enhanced patient care.

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
35.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Ability to give informed consent Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.) No history of previous intraocular surgery in the eye of interest.

排除标准

  • Previous or concurrent use of alpha-antagonist medication Progressive corneal pathology affecting pupil magnification or measurement Uncontrolled hypertension Allergy to the drug used Complicated cataract Pseudoexfoliation and exfoliation syndromes History of ocular trauma or inflammation in the previous 3 months.

结局指标

主要结局

Pupil size in front of the slit lamp and by surgical callipers 3 times during the procedure

时间窗: Baseline on Pre-operative evaluation day, | On the operating table after betadine wash, | Before initiating capsulorhexis, | At the end of the surgery

次要结局

  • 1. Blood pressure(2. Pulse rate)

研究者

发起方
Shivi Srivastava
申办方类型
Other [(self)]
责任方
Principal Investigator
主要研究者

Dr Shivi Srivastava

Lala Lajpat Rai Memorial Medical College Meerut

研究点 (1)

Loading locations...

相似试验