NCT01170130

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

July 13, 2010

Last Update Submit

February 23, 2015

Conditions

Cataract

Keywords

CataractMydriasisLidocaine

Outcome Measures

Primary Outcomes (1)

  • Pupil size after mydriatics

    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%

    no longer then 1 year

Study Arms (1)

Lidmyd

EXPERIMENTAL

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)

Interventions

Lidocaine 1% (sterile)DRUG

during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds

Lidmyd

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cataract
  • men and women
  • can read and sign informed consent form

You may not qualify if:

  • sensitivity to Lidocaine
  • sensitivity to Ephrine
  • any other ocular surgeries
  • diseases like Adie's pupil, Horner syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractMydriasis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPupil Disorders

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Orna Geyer, Professor

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 27, 2010

Study Start

December 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 24, 2015

Record last verified: 2015-02