Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lidocaine Usage for Pupil Dilatation (Mydriasis)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01170130
First received: July 13, 2010
Last updated: January 2, 2013
Last verified: January 2013

July 13, 2010
January 2, 2013
December 2009
October 2012   (final data collection date for primary outcome measure)
Pupil size after mydriatics [ Time Frame: no longer then 1 year ] [ Designated as safety issue: No ]
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%
Same as current
Complete list of historical versions of study NCT01170130 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lidocaine Usage for Pupil Dilatation (Mydriasis)
Efficiency and Safety of Lidocaine Usage for Pupil Dilatation (Mydriasis) During Cataract Surgery

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cataract
Drug: Lidocaine 1% (sterile)
during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds
Other Name: Lidocaine 1% (sterile)
Experimental: Lidmyd
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: Drug: Lidocaine 1% (sterile)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01170130
CMC-09-0017-CTIL
No
Orna Geyer, Carmel Medical Center
Carmel Medical Center
Not Provided
Principal Investigator: Orna Geyer, Professor Carmel Medical Center
Carmel Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP