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
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
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

No publications provided

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:
Pupil Disorders
Eye Diseases
Lens Diseases
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Vasoconstrictor Agents
Cardiovascular Agents processed this record on April 17, 2014