NCT04019691

Brief Summary

The investigators are going to Investigate the comparative efficacy of the patients who underwent cataract surgery with three different multifocal IOLs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

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

August 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

May 13, 2022

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

July 10, 2019

Last Update Submit

May 9, 2022

Conditions

Cataract

Keywords

multifocal intraocular lens

Outcome Measures

Primary Outcomes (3)

  • Postoperative uncorrected near, intermediate, and far visual acuity.

    logMAR

    At 1month and 3months after surgery

  • Postoperative contrast sensitivity in the three groups.

    3, 6, 12, and 18 cycles per degree using a CSV-1000 chart (Vector Vision, reenville, OH) under photopic (85 cd/m2), mesopic (\~3 cd/m2), and mesopic with glare conditions

    Postoperative 3 months

  • Postoperative satisfaction questionnaire.

    patients were shown images and asked to rate the frequency, degree, and discomfort related to the visual artifacts as none, minimal, moderate, or severe (0, 1, 2, or 3 points for the respective levels). The mean score was calculated.

    Postoperative 3 months

Secondary Outcomes (1)

  • Postoperative refractive outcome

    Postoperative 3 months

Study Arms (3)

Mix-and-Match group

ACTIVE COMPARATOR

Cataract surgery and implantation of a Tecnis ZKB00 multifocal IOL with +2.75 D add power (Abbott Medical Optic Inc., Santa Ana, CA) in the dominant eye, and a Tecnis ZLB00 multifocal IOL with +3.25 D add power (Abbott Medical Optics Inc.) in the non-dominant eye.

Device: Mix-and-Match

EDOF group

ACTIVE COMPARATOR

Cataract surgery and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.

Device: EDOF

Trifocal group

ACTIVE COMPARATOR

Cataract surgery and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.

Device: Trifocal

Interventions

Mix-and-MatchDEVICE

Phacoemulsification and implantation of Tecnis ZKB00 multifocal IOL with +2.75 D add power (Abbott Medical Optic Inc., Santa Ana, CA) in the dominant eye, and a Tecnis ZLB00 multifocal IOL with +3.25 D add power (Abbott Medical Optics Inc.) in the non-dominant eye.

Mix-and-Match group
EDOFDEVICE

Phacoemulsification and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.

EDOF group
TrifocalDEVICE

Phacoemulsification and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.

Trifocal group

Eligibility Criteria

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

You may qualify if:

  • Patients with bilateral senile cataracts and the desire to be spectacle-free for all distances

You may not qualify if:

  • Patients younger than 21 years, had corneal astigmatism \>1.00 D, previous ocular surgery or trauma, or ocular disease other than cataracts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Paik DW, Park JS, Yang CM, Lim DH, Chung TY. Comparing the visual outcome, visual quality, and satisfaction among three types of multi-focal intraocular lenses. Sci Rep. 2020 Sep 9;10(1):14832. doi: 10.1038/s41598-020-69318-y.

    PMID: 32908159DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 15, 2019

Study Start

August 1, 2017

Primary Completion

April 7, 2019

Study Completion

June 26, 2020

Last Updated

May 13, 2022

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)