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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031652
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hong Kyun Kim, M.D, Kyungpook National University Hospital

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.

Condition or disease Intervention/treatment
Phacoemulsification 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.

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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : December 31, 2016

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 Name: INFINITI® Vision System




Primary Outcome Measures :
  1. Pain score assessed with Visual Analogue Scale (VAS) [ Time Frame: 1 hour after the end of surgery ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who had senile cataract and needed to receive cataract surgery (phacoemulsification) under topical anesthesia were included.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031652


Locations
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Korea, Republic of
Kyungpook national university hospital
Daegu, Samduk-2ga, Jung-gu, Korea, Republic of, 41944
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Study Director: Hong Kyun Kim, M.D.,Ph.D. Department of ophthalmology, Kyungpook national university hospital
Publications of Results:
Other Publications:
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Responsible Party: Hong Kyun Kim, M.D, Professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT03031652    
Other Study ID Numbers: KNUH
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Kyun Kim, M.D, Kyungpook National University Hospital:
pain
axial length
anterior chamber depth
intraocular pressure