Clinical trial NCT03031652: Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification
Official title: Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phacoemulsification
Keywords: pain
axial length
anterior chamber depth
intraocular pressure
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had senile cataract and needed to receive cataract surgery (phacoemulsification) under topical anesthesia were included.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score assessed with Visual Analogue Scale (VAS)
timeFrame: 1 hour after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
state: Samduk-2ga, Jung-gu
Study officials:
affiliation: Department of ophthalmology, Kyungpook national university hospital
name: Hong Kyun Kim, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1016/s0886-3350(00)00757-4.
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.
citation: 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.
citation: Zauberman H. Extreme deepening of the anterior chamber during phacoemulsification. Ophthalmic Surg. 1992 Aug;23(8):555-6.
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. doi: 10.1002/14651858.CD005276.pub2.
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.