Clinical Outcome of Extended-depth-of-focus Trifocal Intr... | NCT04392024

Studies
Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation

NCT04392024

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

May 10, 2022Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Presbyopia

Interventions

Triumf

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2020Actual

Primary Completion Date

Jan 22, 2022Actual

Completion Date

Jan 26, 2022Actual

First Submitted Date

May 15, 2020

First Submission Date that Met QC Criteria

May 15, 2020

First Posted Date

May 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Triumf	Other	Subjects who have cataract surgery with Triumf IOL	Device: Triumf

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triumf	Device	Triumf is intraocular lens which offers multifocal vision by extended depth of focus and diffractive optics.	Triumf

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uncorrected distant visual acuity	Visual acuity at distant with bare eyes	3 months
Uncorrected near visual acuity	Visual acuity at near with bare eyes	3 months

Secondary Outcomes

Measure	Description	Time Frame
Contrast sensitivity	Ability to recognize figure or letter at different contrast environment	3 months
Quality of Vision	Degree of various symptoms associated with vision

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases