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

Sponsor
Wenzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT01264653
Collaborator
(none)
60
1
1
12
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
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
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • adrenaline hydrochloride
  • Outcome Measures

    Primary Outcome Measures

    1. Pupil size after intracameral adrenaline [1day]

      We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%

    Secondary Outcome Measures

    1. endothelial cell count [1month]

      we would like to evaluate the endothelial cell count 1 month after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Wenzhou Medical College Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    • Study Director: Ayong Yu, Wenzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A-Yong Yu, A-Yong Yu, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT01264653
    Other Study ID Numbers:
    • Wenzhou Medical College
    First Posted:
    Dec 22, 2010
    Last Update Posted:
    Jul 6, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by A-Yong Yu, A-Yong Yu, Wenzhou Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2012