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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01264653
First received: December 20, 2010
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Cataract
 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01264653

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

No publications provided

Responsible Party: A-Yong Yu, Wenzhou Medical College
ClinicalTrials.gov 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 College:
cataract

Additional relevant MeSH terms:
Mydriasis
Cataract
Pupil Disorders
Eye Diseases
Lens Diseases
Epinephrine
Mydriatics
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
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013