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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mix-and-Match
EDOF
Trifocal
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring multifocal intraocular lens

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Mix-and-Match group

EDOF group

Trifocal group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative refractive outcome
Diopter

Full Information

First Posted
July 10, 2019
Last Updated
May 9, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04019691
Brief Title
Comparing the Visual Outcome, Visual Quality, and Satisfaction Among Three Types of Multi-focal Intraocular Lenses
Official Title
Comparing the Visual Outcome, Visual Quality, and Satisfaction Among Three Types of Multi-focal Intraocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 7, 2019 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
multifocal intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mix-and-Match group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EDOF group
Arm Type
Active Comparator
Arm Description
Cataract surgery and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.
Arm Title
Trifocal group
Arm Type
Active Comparator
Arm Description
Cataract surgery and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.
Intervention Type
Device
Intervention Name(s)
Mix-and-Match
Intervention Description
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
Intervention Name(s)
EDOF
Intervention Description
Phacoemulsification and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.
Intervention Type
Device
Intervention Name(s)
Trifocal
Intervention Description
Phacoemulsification and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.
Primary Outcome Measure Information:
Title
Postoperative uncorrected near, intermediate, and far visual acuity.
Description
logMAR
Time Frame
At 1month and 3months after surgery
Title
Postoperative contrast sensitivity in the three groups.
Description
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
Time Frame
Postoperative 3 months
Title
Postoperative satisfaction questionnaire.
Description
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.
Time Frame
Postoperative 3 months
Secondary Outcome Measure Information:
Title
Postoperative refractive outcome
Description
Diopter
Time Frame
Postoperative 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32908159
Citation
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. Erratum In: Sci Rep. 2021 May 3;11(1):9776.
Results Reference
derived

Learn more about this trial

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

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