PhacoemulsificationNCT03031652
Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification
An observational study of Phacoemulsification, run by Kyungpook National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Phacoemulsification
- What is being tested?
- Phacoemulsification
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2016to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who had senile cataract and needed to receive cataract surgery (phacoemulsification) under topical anesthesia were included.
Who may be able to join
- Patients underwent phacoemulsification with topical anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook national university hospital
Daegu, Samduk-2ga, Jung-gu, 41944
About this study
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.
Read the 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.
- Conditions
- Phacoemulsification
- Being tested
- Phacoemulsification
- Keywords
- pain, axial length, anterior chamber depth, intraocular pressure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationDevice
Also called INFINITI® Vision System
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
| Study group | Role | What they receive |
|---|---|---|
| Enrolled group | Patients who had senile cataract and underwent phacoemulsification with topical anesthesia. Receives: Device: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Mar 2016
- Primary completion31 Aug 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PhacoemulsificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Kyun Kim, M.D, Kyungpook National University Hospital
- Investigators
- Hong Kyun Kim, M.D.,Ph.D., Study director, Department of ophthalmology, Kyungpook national university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031652
- Sponsor's protocol ID
- KNUH
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 8784636O'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.
PubMed 11408135Ursea 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.
PubMed 21596244Cho 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.
PubMed 20157408Zauberman H. Extreme deepening of the anterior chamber during phacoemulsification. Ophthalmic Surg. 1992 Aug;23(8):555-6.
PubMed 1508488Ezra 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.
PubMed 17636793Nahra 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.
PubMed 16355958
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification
- ClinicalTrials.gov ID
- NCT03031652
- Acronym / sponsor ID
- KNUH
- Conditions
- Phacoemulsification
- Keywords
- pain, axial length, anterior chamber depth, intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled group | – | Device: PhacoemulsificationPatients who had senile cataract and underwent phacoemulsification with topical anesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had senile cataract and needed to receive cataract surgery (phacoemulsification) under topical anesthesia were included.
Key inclusion criteria (1 listed)
- Patients underwent phacoemulsification with topical anesthesia
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhacoemulsificationAlso: INFINITI® Vision SystemThe 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 | Device | Enrolled group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Background: PubMed 8784636Fichman 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.
- Background: PubMed 11408135O'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.
- Background: PubMed 21596244Ursea 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.
- Background: PubMed 20157408Cho 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.
- Background: PubMed 1508488Zauberman H. Extreme deepening of the anterior chamber during phacoemulsification. Ophthalmic Surg. 1992 Aug;23(8):555-6.
- Background: PubMed 17636793Ezra 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.
- Results publication: PubMed 16355958Nahra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Kyun Kim, M.D.,Ph.D. study director
Department of ophthalmology, Kyungpook national university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phacoemulsification, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score assessed with Visual Analogue Scale (VAS) (time frame: 1 hour after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031652, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.