Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

Cataract Clinical Trial

Official title:

Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264653
• Other study ID #: Wenzhou Medical College
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: July 4, 2012
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• male and female

• can read and sign informed consent form;

• Clinical diagnosis of cataract

• Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

• sensitivity to adrenalin;

• sensitivity to topical mydriatics;

• any other ocular surgeries;

• iris abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cataract
• Mydriasis

Intervention

Drug:
• adrenalin
adrenalin 0.01%

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil size after intracameral adrenaline	We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%	1day	No
Secondary	endothelial cell count	we would like to evaluate the endothelial cell count 1 month after surgery	1month	Yes