Lidocaine Usage for Pupil Dilatation (Mydriasis)
|ClinicalTrials.gov Identifier: NCT01170130|
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment|
|Cataract||Drug: Lidocaine 1% (sterile)|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|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 :||December 2009|
|Primary Completion Date :||October 2012|
|Study Completion Date :||October 2012|
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
- Pupil size after mydriatics [ Time Frame: 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%
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170130
|Principal Investigator:||Orna Geyer, Professor||Carmel Medical Center|