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

Phacoemulsification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031652
• Other study ID #: KNUH
• Status: Completed
• Phase: N/A
• First received: January 20, 2017
• Last updated: January 24, 2017
• Start date: March 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2017
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Phacoemulsification

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Daegu	Samduk-2ga, Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

Ezra DG, Allan BD. Topical anaesthesia alone versus topical anaesthesia with intracameral lidocaine for phacoemulsification. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005276. Review. — View Citation

Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg. 1996 Jun;22(5):612-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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