NCT01381783

Brief Summary

The purpose of this study is to determine if topical anesthesia is safe for phacoemulsification in eyes with comorbidities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

June 27, 2011

Status Verified

March 1, 2011

Enrollment Period

5.2 years

First QC Date

April 7, 2011

Last Update Submit

June 24, 2011

Conditions

Phacoemulsification

Keywords

topical anaesthesiaPhacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Number of Postoperative events

    To describe any postoperatives events in a phacoemulsification surgery under topical anesthesia

    12 months

Study Arms (1)

Topical anesthesia

OTHER
Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

Phacoemulsification under topical anesthesia

Topical anesthesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cataract with a visual acuity less than 0.8

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2011

First Posted

June 27, 2011

Study Start

January 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-03