Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical College Identifier:
First received: December 20, 2010
Last updated: July 4, 2012
Last verified: July 2012
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.

Condition Intervention
Drug: adrenalin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

Resource links provided by NLM:

Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • Pupil size after intracameral adrenaline [ Time Frame: 1day ] [ Designated as safety issue: No ]
    We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%

Secondary Outcome Measures:
  • endothelial cell count [ Time Frame: 1month ] [ Designated as safety issue: Yes ]
    we would like to evaluate the endothelial cell count 1 month after surgery

Enrollment: 60
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group,control group
Intraocular adrenalin,topical mydriatics, experimental group: Intervention: Procedure:refractive cataract surgery with Intraocular adrenalin, control group:refractive cataract surgery with topical mydriatics
Drug: adrenalin
adrenalin 0.01%
Other Name: adrenaline hydrochloride


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01264653

China, Zhejiang
Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Wenzhou Medical University
Study Director: Ayong Yu Wenzhou Medical University
  More Information

Responsible Party: A-Yong Yu, Wenzhou Medical College Identifier: NCT01264653     History of Changes
Other Study ID Numbers: Wenzhou Medical College 
Study First Received: December 20, 2010
Last Updated: July 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Wenzhou Medical University:

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Pupil Disorders
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on October 21, 2016