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Prospective Randomized, Paired-Eye, Controlled Study on Comparison of Intraoperative Patient Experience and Postoperative Clinical Outcomes after Phacoemulsification Cataract Surgery with Illuminator Chopper and Conventional Chopper with Surgical microscope light source

Status Approved

First Submitted Date

2021/03/23
Registered Date

2021/03/30
Last Updated Date

2023/02/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006042
Unique Protocol ID	NCv1.2
Public/Brief Title	Comparison of Cataract Surgery with Illuminator Chopper and Surgical microscope light source
Scientific Title	Prospective Randomized, Paired-Eye, Controlled Study on Comparison of Intraoperative Patient Experience and Postoperative Clinical Outcomes after Phacoemulsification Cataract Surgery with Illuminator Chopper and Conventional Chopper with Surgical microscope light source
Acronym	Illuminator chopper
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2021AS0063
Approval Date	2021-03-09
Institutional Review Board Name	Korea University Ansan Hospital Institutional Review Board
Institutional Review Board Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Institutional Review Board Telephone	031-412-6514
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Dongheun Nam
Title	Professor
Telephone	+82-32-460-3364
Affiliation	Gachon University Gil Medical Center
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Contact Person for Public Queries
Name	Hee Young Kim
Title	Clinical research co
Telephone	+82-31-412-5168
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Contact Person for Updating Information
Name	Young Sub Eom
Title	Professor
Telephone	+82-31-412-5168
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 4
Overall Recruitment Status	Completed
Date of First Enrollment	2021-03-23 Actual
Target Number of Participant	90
Primary Completion Date	2022-11-24 , Actual
Study Completion Date	2022-11-24 , Actual
Name of Study	Korea University Ansan Hospital
Recruitment Status	Completed
Date of First Enrollment	2021-06-09 ,
Recruitment Status by Participating Study Site 2
Name of Study	Gachon University Gil Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-03-23 ,
Recruitment Status by Participating Study Site 3
Name of Study	Inje University Ilsan Paik Hospital
Recruitment Status	Completed
Date of First Enrollment	2021-10-12 ,
Recruitment Status by Participating Study Site 4
Name of Study	Soon Chun Hyang University Hospital Seoul
Recruitment Status	Completed
Date of First Enrollment	2021-09-16 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Drug Development Fund
Organization Type	Government
Project ID	HI20C2151

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea University Ansan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this clinical study is investigate whether there is a difference in discomfort and the clinical outcomes after cataract surgery between performing cataract surgery under a surgical microscope light source traditionally used and performing cataract surgery using an illuminator chaper light source developed by Oculight.

Study Summary Information

Lay Summary

The purpose of this clinical study is investigate whether there is a difference in discomfort and the clinical outcomes after cataract surgery between performing cataract surgery under a surgical microscope light source traditionally used and performing cataract surgery using an illuminator chaper light source developed by Oculight.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Factorial
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	The order of selection of surgical methods will be randomly assigned to patients who have listened to the explanation of the clinical trial and voluntarily agreed to participate. The Excel program is used to generate random numbers 1 or 2, and in case of 1, the right eye is operated using an illuminat or chopper for cataract surgery and the left eye is operated under surgical microscope light source with conventional chopper. 1. Cataract surgery on the right with an illuminator chopper, and surgery on the left eye under microscope light source. 2. Cataract surgery on the right under microscope light source, and surgery on the left eye with an illuminator chopper.
Number of Arms	2
Arm 1	Arm Label Right eye with illuminator chopper
	Target Number of Participant 45
	Arm Type Experimental
	Arm Description Cataract surgery on the right with an illuminator chopper, and surgery on the left eye under microscope light source
Arm 2	Arm Label Left eye with illuminator chopper
	Target Number of Participant 45
	Arm Type Experimental
	Arm Description Cataract surgery on the right under microscope light source, and surgery on the left eye with an illuminator chopper

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H00-H59)Diseases of the eye and adnexa (H26.99)Cataract, unspecified, unspecified side Cataract
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~No Limit
	Description 1. Over 20 years old 2. patients diagnosed with binocular cataract 3. when both eyes are suitable for cataract surgery 4. if the best corrected visual acuity is expected to be 0.5 Snellen or higher after cataract surgery 5. patients for whom no other secondary surgery was planned during the study period 6. patients who can comply with the examination procedure during the entire study period 7. patients who provide written consent.
Exclusion Criteria	1. in the case of eye diseases other than cataracts that may cause complications or affect clinical outcomes (e.g., anterior segment pathology, corneal dystrophy, ocular inflammation, retinal disorders, or neurological disorders) 2. in case of preoperative ocular or systemic conditions and drug use that may affect the research results or cause excessive risk to the study subject, or complications may occur 3. congenital eye abnormalities 4. if subjects have a history of ophthalmic surgery that may affect the study results or pose a risk to the patient 5. when prior consent cannot be obtained.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Patient experience score during surgery
Timepoint	Immediately after surgery
Secondary Outcome(s) 1
Outcome	Capsulorrhexis area
Timepoint	6 months after surgery
Secondary Outcome(s) 2
Outcome	Anterior capsule opacity score
Timepoint	6 months after surgery
Secondary Outcome(s) 3
Outcome	Posterior capsule opacity score
Timepoint	6 months after surgery
Secondary Outcome(s) 4
Outcome	Score for evaluating the degree of cooperation of the patient during surgery
Timepoint	Immediately after surgery
Secondary Outcome(s) 5
Outcome	Operation time and ultrasound use time
Timepoint	Immediately after surgery
Secondary Outcome(s) 6
Outcome	Visual acuity
Timepoint	1 week, 1 month, 3, and 6 months after surgery
Secondary Outcome(s) 7
Outcome	Corneal thickness
Timepoint	1 week, 1 month, 3, and 6 months after surgery
Secondary Outcome(s) 8
Outcome	Macular thickness
Timepoint	1 week, 1 month, 3, and 6 months after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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