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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

Page last updated: August 23, 2015

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