Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification

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.

Study Overview

• Status: Completed
• Conditions: Phacoemulsification
• Intervention / Treatment: Device: Phacoemulsification

Detailed Description

Patients scheduled for elective phacoemulsification and intraocular lens implantation with the Infiniti Vision System (Alcon, Fort Worth, USA) were included. All operations were performed in Kyungpook National University Hospital by the same surgeon between March and August 2016.

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Korea, Republic of
  • Samduk-2ga, Jung-gu
    • Daegu, Samduk-2ga, Jung-gu, Korea, Republic of, 41944
      • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Patients underwent phacoemulsification with topical anesthesia

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrolled group; Patients who had senile cataract and underwent phacoemulsification with topical anesthesia.	Device: Phacoemulsification; 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; Other Names: INFINITI® Vision System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Study Director: Hong Kyun Kim, M.D.,Ph.D., Department of ophthalmology, Kyungpook national university hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: pain; intraocular pressure; axial length; anterior chamber depth
• Other Study ID Numbers: KNUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No