Lidocaine Usage for Pupil Dilatation (Mydriasis)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine 1% (sterile)
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract focused on measuring Cataract, Mydriasis, Lidocaine
Eligibility Criteria
Inclusion Criteria:
- cataract
- men and women
- can read and sign informed consent form
Exclusion Criteria:
- sensitivity to Lidocaine
- sensitivity to Ephrine
- any other ocular surgeries
- diseases like Adie's pupil, Horner syndrome
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lidmyd
Arm Description
The same group is used for the first and the second part of the experiment. Initially the patients will be given topical cyclopentolate 1% and Phenylephrine 10% and the pupil diameter will be recorded. In the second part of the experiment lidocaine 1% will be introduced intracamerally and the pupil size will be recorded again. The 2 measurements will be statistically compared/evaluated.
Outcomes
Primary Outcome Measures
Pupil size after mydriatics
We would like to evaluate whether Pupil size dilated with Intracameral Lidocaine 1% is as effective dilator compared with Topical Cyclopentolate 1% and Phenylephrine 10%
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01170130
Brief Title
Lidocaine Usage for Pupil Dilatation (Mydriasis)
Official Title
Efficiency and Safety of Lidocaine Usage for Pupil Dilatation (Mydriasis) During Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine 1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective mydriasis during phacoemulsification surgery.
Detailed Description
Former studied done on the effect of Intracameral lidocaine 1% compared to topical mydriatic agents for achieving effective mydriasis during phacoemulsification surgery have compared 2 different groups of patients, ie; One group received topical agents and the other received intracameral lidocaine. The resultant pupil size was recorded and evaluated in the 2 groups. Our purpose is to compare the effect of these agents on the same group of people.
Patients recruited will be invited first for evaluation at least 1 week before the surgery. During this evaluation 1 dose (drop) of topical cyclopentolate 1% and Phenylephrine 10% will be instilled to the evaluated eye 3 times at 10 minutes intervals. After 1 hour from the last instillation pupil diameter will be recorded. In the second part of this study during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds. the resultant values will be evaluated/compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Mydriasis, Lidocaine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidmyd
Arm Type
Experimental
Arm Description
The same group is used for the first and the second part of the experiment. Initially the patients will be given topical cyclopentolate 1% and Phenylephrine 10% and the pupil diameter will be recorded. In the second part of the experiment lidocaine 1% will be introduced intracamerally and the pupil size will be recorded again. The 2 measurements will be statistically compared/evaluated.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1% (sterile)
Intervention Description
during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds
Primary Outcome Measure Information:
Title
Pupil size after mydriatics
Description
We would like to evaluate whether Pupil size dilated with Intracameral Lidocaine 1% is as effective dilator compared with Topical Cyclopentolate 1% and Phenylephrine 10%
Time Frame
no longer then 1 year
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:
cataract
men and women
can read and sign informed consent form
Exclusion Criteria:
sensitivity to Lidocaine
sensitivity to Ephrine
any other ocular surgeries
diseases like Adie's pupil, Horner syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orna Geyer, Professor
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Lidocaine Usage for Pupil Dilatation (Mydriasis)
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