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

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Mix-and-Match; Device: EDOF; Device: Trifocal

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Active Comparator: EDOF group; Cataract surgery and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.	Device: EDOF; Phacoemulsification and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.
Active Comparator: Trifocal group; Cataract surgery and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.	Device: Trifocal; Phacoemulsification and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative refractive outcome	Diopter	Postoperative 3 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 7, 2019
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: multifocal intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SMC 2019-06-017-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No