Lidocaine Usage for Pupil Dilatation (Mydriasis)

Israel Healthcare Foundation

Status: Completed

Conditions: Cataract

Treatments: Drug: Lidocaine 1% (sterile)

Study type: Interventional

Funder types: Other

Identifiers

NCT01170130

CMC-09-0017-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Lidmyd

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine 1% (sterile)