Comparing the Visual Outcome, Visual Quality, and Satisfaction Among Three Types of Multi-focal Intraocular Lenses

NCT ID: NCT04019691

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-06-26

Brief Summary

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

Detailed Description

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Going to analyze the clinical results of 60 patients who underwent bilateral cataract surgery and multifocal IOL implantation. The patients were divided into the following three groups: Mix-and-Match, EDOF, and Trifocal. The clinical assessments included uncorrected near, intermediate, distance and best corrected distance visual acuity, defocus curves, contrast sensitivity, and reading speed. Patient satisfaction was evaluated by questionnaire. All outcomes were compared among the three groups.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mix-and-Match group

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.

Group Type ACTIVE_COMPARATOR

Mix-and-Match

Intervention Type DEVICE

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.

EDOF group

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

Group Type ACTIVE_COMPARATOR

EDOF

Intervention Type DEVICE

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

Trifocal group

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

Group Type ACTIVE_COMPARATOR

Trifocal

Intervention Type DEVICE

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

Interventions

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Mix-and-Match

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.

Intervention Type DEVICE

EDOF

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

Intervention Type DEVICE

Trifocal

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32908159 (View on PubMed)

Other Identifiers

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SMC 2019-06-017-001

Identifier Type: -

Identifier Source: org_study_id

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