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
  Purpose

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 Intervention
Cataract
Drug: Lidocaine 1% (sterile)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficiency and Safety of Lidocaine Usage for Pupil Dilatation (Mydriasis) During Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • 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%


Estimated Enrollment: 100
Study Start Date: December 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Lidocaine 1% (sterile)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170130

Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Orna Geyer, Professor Carmel Medical Center
  More Information

No publications provided

Responsible Party: Orna Geyer, professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01170130     History of Changes
Other Study ID Numbers: CMC-09-0017-CTIL
Study First Received: July 13, 2010
Last Updated: January 2, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Cataract
Mydriasis
Lidocaine

Additional relevant MeSH terms:
Dilatation, Pathologic
Mydriasis
Cataract
Pathological Conditions, Anatomical
Pupil Disorders
Eye Diseases
Lens Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014