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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
adrenalin
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract focused on measuring cataract

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wenzhou Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group,control group

Arm Description

Intraocular adrenalin,topical mydriatics, experimental group: Intervention: Procedure:refractive cataract surgery with Intraocular adrenalin, control group:refractive cataract surgery with topical mydriatics

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2010
Last Updated
July 4, 2012
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01264653
Brief Title
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery
Official Title
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group,control group
Arm Type
Experimental
Arm Description
Intraocular adrenalin,topical mydriatics, experimental group: Intervention: Procedure:refractive cataract surgery with Intraocular adrenalin, control group:refractive cataract surgery with topical mydriatics
Intervention Type
Drug
Intervention Name(s)
adrenalin
Other Intervention Name(s)
adrenaline hydrochloride
Intervention Description
adrenalin 0.01%
Primary Outcome Measure Information:
Title
Pupil size after intracameral adrenaline
Description
We would like to evaluate Pupil size dilated with intracameral adrenaline 0.01%
Time Frame
1day
Secondary Outcome Measure Information:
Title
endothelial cell count
Description
we would like to evaluate the endothelial cell count 1 month after surgery
Time Frame
1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayong Yu
Organizational Affiliation
Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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