Lidocaine Usage for Pupil Dilatation (Mydriasis)
Information source: Carmel Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Lidocaine 1% (sterile) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Carmel Medical Center Official(s) and/or principal investigator(s): Orna Geyer, Professor, Principal Investigator, Affiliation: Carmel Medical Center
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.
Clinical Details
Official title: Efficiency and Safety of Lidocaine Usage for Pupil Dilatation (Mydriasis) During Cataract Surgery
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Pupil size after mydriatics
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
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2009
Last updated: February 23, 2015
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