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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264653
First Posted: December 22, 2010
Last Update Posted: July 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical College
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 A-Yong Yu, Wenzhou Medical College:

Primary Outcome Measures:
  • Pupil size after intracameral adrenaline [ Time Frame: 1day ]
    We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%


Secondary Outcome Measures:
  • endothelial cell count [ Time Frame: 1month ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264653


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

Responsible Party: A-Yong Yu, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01264653     History of Changes
Other Study ID Numbers: Wenzhou Medical College
First Submitted: December 20, 2010
First Posted: December 22, 2010
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by A-Yong Yu, Wenzhou Medical College:
cataract

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