NCT03031652

Brief Summary

Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h after surgery was assessed and compared using a visual analog scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 20, 2017

Last Update Submit

January 24, 2017

Conditions

Phacoemulsification

Keywords

painaxial lengthanterior chamber depthintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Pain score assessed with Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. A third person assessed subjective pain using a pain visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable) after surgery.

    1 hour after the end of surgery

Study Arms (1)

Enrolled group

Patients who had senile cataract and underwent phacoemulsification with topical anesthesia.

Device: Phacoemulsification

Interventions

PhacoemulsificationDEVICE

The device device used to provide and perform small profile entry for cataract extraction with or without option of insertion of a specified intraocular lens implant

Also known as: INFINITI® Vision System
Enrolled group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had senile cataract and needed to receive cataract surgery (phacoemulsification) under topical anesthesia were included.

You may qualify if:

  • Patients underwent phacoemulsification with topical anesthesia

You may not qualify if:

  • Patients who needed general anesthesia or were taking medications capable of affecting perceived pain
  • Patients who had traumatic cataract and/or conditions likely to require vitrectomy and trans-scleral fixation of posterior chamber intraocular lens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university hospital

Daegu, Samduk-2ga, Jung-gu, 41944, South Korea

Location

Related Publications (7)

  • Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4. doi: 10.1016/s0886-3350(96)80019-8.

    PMID: 8784636BACKGROUND

  • O'Brien PD, Fulcher T, Wallace D, Power W. Patient pain during different stages of phacoemulsification using topical anesthesia. J Cataract Refract Surg. 2001 Jun;27(6):880-3. doi: 10.1016/s0886-3350(00)00757-4.

    PMID: 11408135BACKGROUND

  • Ursea R, Feng MT, Zhou M, Lien V, Loeb R. Pain perception in sequential cataract surgery: comparison of first and second procedures. J Cataract Refract Surg. 2011 Jun;37(6):1009-14. doi: 10.1016/j.jcrs.2011.01.020.

    PMID: 21596244BACKGROUND

  • Cho YK, Chang HS, Kim MS. Risk factors for endothelial cell loss after phacoemulsification: comparison in different anterior chamber depth groups. Korean J Ophthalmol. 2010 Feb;24(1):10-5. doi: 10.3341/kjo.2010.24.1.10. Epub 2010 Feb 5.

    PMID: 20157408BACKGROUND

  • Zauberman H. Extreme deepening of the anterior chamber during phacoemulsification. Ophthalmic Surg. 1992 Aug;23(8):555-6.

    PMID: 1508488BACKGROUND

  • Ezra DG, Allan BD. Topical anaesthesia alone versus topical anaesthesia with intracameral lidocaine for phacoemulsification. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005276. doi: 10.1002/14651858.CD005276.pub2.

    PMID: 17636793BACKGROUND

  • Nahra Saad D, Castilla Cespedes M, Martinez Palmer A, Pazos Lopez M. Phacoemulsification and lens-iris diaphragm retropulsion syndrome. Ophthalmic Surg Lasers Imaging. 2005 Nov-Dec;36(6):512-3.

    PMID: 16355958RESULT

MeSH Terms

Conditions

Pain

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Hong Kyun Kim, M.D.,Ph.D.

    Department of ophthalmology, Kyungpook national university hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 25, 2017

Study Start

March 1, 2016

Primary Completion

August 31, 2016

Study Completion

December 31, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)