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Completed

NCT Number: NCT04019691

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mix-and-Match

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

Device

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

Trifocal

Device

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

Primary outcomes

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

    Time frame: At 1month and 3months after surgery

    logMAR

  2. Postoperative contrast sensitivity in the three groups.

    Time frame: Postoperative 3 months

    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

  3. Postoperative satisfaction questionnaire.

    Time frame: Postoperative 3 months

    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 outcomes

  1. Postoperative refractive outcome

    Time frame: Postoperative 3 months

    Diopter

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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