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

NCT ID: NCT03031652

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Phacoemulsification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enrolled group

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

Phacoemulsification

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

INFINITIĀ® Vision System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hong Kyun Kim, M.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hong Kyun Kim, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Department of ophthalmology, Kyungpook national university hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kyungpook national university hospital

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8784636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11408135 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21596244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20157408 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1508488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17636793 (View on PubMed)

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.

Reference Type RESULT
PMID: 16355958 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KNUH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IOP Changes Associated With SICS and Phako
NCT02642211 COMPLETED EARLY_PHASE1