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

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

Sponsors

Lead Sponsor: Samsung Medical Center

Source Samsung Medical Center
Brief Summary

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

Overall Status Active, not recruiting
Start Date August 1, 2017
Completion Date September 30, 2019
Primary Completion Date August 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative uncorrected near, intermediate, and far visual acuity. At 1month and 3months after surgery
Postoperative contrast sensitivity in the three groups. Postoperative 3 months
Postoperative satisfaction questionnaire. Postoperative 3 months
Secondary Outcome
Measure Time Frame
Postoperative refractive outcome Postoperative 3 months
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Mix-and-Match

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.

Arm Group Label: Mix-and-Match group

Intervention Type: Device

Intervention Name: EDOF

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

Arm Group Label: EDOF group

Intervention Type: Device

Intervention Name: Trifocal

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

Arm Group Label: Trifocal group

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

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Samsung Medical Center
Location Countries

Korea, Republic of

Verification Date

June 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Mix-and-Match group

Type: Active Comparator

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.

Label: EDOF group

Type: Active Comparator

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

Label: Trifocal group

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov