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  • Status : Approved
    • First Submitted Date : 2019/03/20
    • Registered Date : 2019/05/15
    • Last Updated Date : 2019/05/14
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1. Background

Background Information
CRIS
Registration Number
KCT0003922 
Unique Protocol ID 2018AS0150 
Public/Brief Title Comparison study on the effect of capsular tension ring according to the number of intraocular lens haptics 
Scientific Title Prospective randomized clinical study on the effect of different number of intraocular lens haptics with or without a capsular tension ring on clinical outcomes after cataract surgery  
Acronym ARTIS CTR 
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 2018AS0150 
Approval Date 2018-11-13 
Institutional Review Board  
Name Korea University Ansan Hospital Institutional Review Board 
Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do 
Telephone 031-412-6514 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Youngsub Eom 
Title Pf 
Telephone +82-31-412-4267 
Affiliation Korea University Ansan Hospital 
Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do 
Contact Person for Public Queries
Name Youngsub Eom 
Title Pf 
Telephone +82-31-412-4267 
Affiliation Korea University Ansan Hospital 
Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do 
Contact Person for Updating Information
Name Hee Young Kim 
Title Ms 
Telephone +82-31-412-4267 
Affiliation Korea University Ansan Hospital 
Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-06-07 , Anticipated
Target Number of Participant 40
Primary Completion Date 2019-07-16 , Anticipated
Study Completion Date 2019-07-16 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Korea University Ansan Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-06-07 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Seokwang medical 
Organization Type Pharmaceutical Company  
Project ID 2018-01 

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary The intraocular lens (IOL) used in cataract surgery can be classified according to the shape of the haptic. The most commonly used IOLs have two C-loop haptics or four plate haptics. Recently, hydrophobic IOLs with 4 plate haptics have been used. In the case of hydrophobic IOLs, the glass transition temperature is higher than that of hydrophilic materials, so that they have harder characteristics and have excellent stability after cataract surgery.
It is known that the capsular tension ring stabilizes the lens capsule and improves the stability of the IOLs by preventing posterior capsule contracture.
In a comparative study of a hydrophilic IOL with two haptics and a hydrophilic IOL with four haptics, it has been reported that the posterior position stability of the hydrophilic IOL with four haptics is superior. Similarly, in the case of hydrophobic IOLs, posterior positional stability of the IOLs with four haptics is considered to be superior to that of the IOLs with two haptics. Thus, this study purposed to evaluate the effect of different number of intraocular lens haptics with or without a capsular tension ring on clinical outcomes after cataract surgery.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Medical Device  
Intervention Description Patients who voluntarily agreed to participate in the study are randomly assigned to one of two groups accoding to random number 1 or 2 using the Excel program. In case 1, the Artis intraocular lens and capsular tension ring are inserted into one eye and the Artis IOL alone is inserted in the other eye. In case 2, the Tecnis intraocular lens and capsular tension ring are inserted into one eye, and the Tecnis IOL alone is inserted into the other eye.  
Number of Arms
Arm 1 Arm Label Artis group 
Target Number of Participant 20 
Arm Type Experimental 
Arm Description In the Artis group, the Artis intraocular lens and capsular tension ring are inserted into one eye and the Artis IOL alone is inserted in the other eye during cataract surgery. 
Arm 2 Arm Label Tecnis group 
Target Number of Participant 20 
Arm Type Active comparator 
Arm Description In the Tecnis group, the Tecnis intraocular lens and capsular tension ring are inserted into one eye, and the Tecnis IOL alone is inserted into the other eye during cataract surgery. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the eye and adnexa
 Cataract
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 21 Year ~ No Limit
Description -Subjects who voluntarily agreed to participate in the study after reading the clinical trial explanations and agreements, listening to the explanations for the study
-Subjects who visit Korea University Ansan Hospital between the IRB approval and June 30, 2019 and plan to undergo bilateral cataract surgery for cataract.
-Subjects who are 21 years of age or older
-Subjects who wish to undergo second cataract surgery between 1 and 4 weeks after the first cataract surgery
-Subjects who expected to have a best corrected visual acuity of 20/40 or better in the operated eye
-Subjects who have examinmation of biometry before cataract surgery using IOL Master®
-Subjects who have no opacity of the ocular medium except cataract.  
Exclusion Criteria - Subjects who have a disease that can affect vision
- Subjects who have amblyopia or strabismus
- Subjects who have an abnormality that can cause decentraion of the intraocular lens after cataract surgery
- Subjects who have corneal disease such as keratoconus and corneal dystrophy
- Subjects who have previous history of ocular trauma or refractive surgery
- Subjects who are using general medicine or eye drops that can affect vision.
- Subjects who are currently participating in other clinical studies or have participated in other clinical studies within 30 days of the strat day the study  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome clinical-equivalence 
Primary Outcome(s) 1 
Outcome Predicted refractive error 
Timepoint Postoperative 1 and 3 months 
Primary Outcome(s) 2 
Outcome Intraocular lens position and tilt 
Timepoint Postoperative 1 and 3 months 
Secondary Outcome(s) 1 
Outcome The area of continuous curvilinear capsulorhexis 
Timepoint Postoperative 1 and 3 months 
Secondary Outcome(s) 2 
Outcome Uncorrected and corrected visual acuity 
Timepoint Postoperative 1 and 3 months 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

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

Sharing of Study Data Information
Sharing Statement No 
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