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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019691
• Other study ID #: SMC 2019-06-017-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 26, 2020

Study information

• Verified date: April 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 26, 2020
• Est. primary completion date: April 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.
• EDOF
Phacoemulsification and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.
• Trifocal
Phacoemulsification and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative uncorrected near, intermediate, and far visual acuity.	logMAR	At 1month and 3months after surgery
Primary	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
Primary	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	Postoperative refractive outcome	Diopter	Postoperative 3 months