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

July 4, 2012 updated by: A-Yong Yu, Wenzhou Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pupil size after intracameral adrenaline
Time Frame: 1day
We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%
1day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial cell count
Time Frame: 1month
we would like to evaluate the endothelial cell count 1 month after surgery
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Study Director: Ayong Yu, Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 4, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wenzhou Medical College

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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