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

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT04019691
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2019-04-07
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-15
• Status Verified: 2020-04
• Study Completion: 2020-06-26
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative contrast sensitivity in the three groups.	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
Postoperative uncorrected near, intermediate, and far visual acuity.	At 1month and 3months after surgery	logMAR
Postoperative satisfaction questionnaire.	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 Outcome Measures

Name	Time	Method
Postoperative refractive outcome	Postoperative 3 months	Diopter

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of