Lidocaine Usage for Pupil Dilatation (Mydriasis)

Sponsor
Carmel Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01170130
Collaborator
(none)
100
1
34

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine 1% (sterile)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Efficiency and Safety of Lidocaine Usage for Pupil Dilatation (Mydriasis) During Cataract Surgery
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Pupil size after mydriatics [no longer then 1 year]

    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%

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Carmel Medical Center

Investigators

  • Principal Investigator: Orna Geyer, Professor, Carmel Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Orna Geyer, professor, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01170130
Other Study ID Numbers:
  • CMC-09-0017-CTIL
First Posted:
Jul 27, 2010
Last Update Posted:
Feb 24, 2015
Last Verified:
Feb 1, 2015
Keywords provided by Orna Geyer, professor, Carmel Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2015