NCT04392024

Brief Summary

Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 15, 2020

Last Update Submit

May 9, 2022

Conditions

Presbyopia

Keywords

Depth and focus

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Contrast sensitivity

    3 months

  • Quality of Vision

    3 months

Study Arms (1)

Triumf

OTHER

Subjects who have cataract surgery with Triumf IOL

Device: Triumf

Interventions

TriumfDEVICE

Triumf is intraocular lens which offers multifocal vision by extended depth of focus and diffractive optics.

Triumf

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Tae-Young Chung, PhD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 18, 2020

Study Start

January 29, 2020

Primary Completion

January 22, 2022

Study Completion

January 26, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

KR(1)