Back to resultsClinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Triumf
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Depth and focus
Eligibility Criteria
Inclusion Criteria:
- Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
- Age-related cataract
- A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
- A patient want presbyopia correction at the same time as cataract surgery
- A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- Written informed consent to surgery and participation in the study
Exclusion Criteria:
- Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
- Pregnant woman and lactating woman
- A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
- A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
- If expectations for presbyopia correction are too high
- Those who are not able to read and understand the informed consent (illiterate or foreigners)
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Triumf
Arm Description
Subjects who have cataract surgery with Triumf IOL
Outcomes
Primary Outcome Measures
Uncorrected distant visual acuity
Visual acuity at distant with bare eyes
Uncorrected near visual acuity
Visual acuity at near with bare eyes
Secondary Outcome Measures
Contrast sensitivity
Ability to recognize figure or letter at different contrast environment
Quality of Vision
Degree of various symptoms associated with vision
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04392024
Brief Title
Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
Official Title
Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
January 22, 2022 (Actual)
Study Completion Date
January 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Depth and focus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triumf
Arm Type
Other
Arm Description
Subjects who have cataract surgery with Triumf IOL
Intervention Type
Device
Intervention Name(s)
Triumf
Intervention Description
Triumf is intraocular lens which offers multifocal vision by extended depth of focus and diffractive optics.
Primary Outcome Measure Information:
Title
Uncorrected distant visual acuity
Description
Visual acuity at distant with bare eyes
Time Frame
3 months
Title
Uncorrected near visual acuity
Description
Visual acuity at near with bare eyes
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Contrast sensitivity
Description
Ability to recognize figure or letter at different contrast environment
Time Frame
3 months
Title
Quality of Vision
Description
Degree of various symptoms associated with vision
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
Age-related cataract
A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
A patient want presbyopia correction at the same time as cataract surgery
A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
Written informed consent to surgery and participation in the study
Exclusion Criteria:
Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
Pregnant woman and lactating woman
A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
If expectations for presbyopia correction are too high
Those who are not able to read and understand the informed consent (illiterate or foreigners)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Young Chung, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
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