Comparison of Outcomes With Multifocal Intraocular Lenses (COMIL)

The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313 MF30T.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: SN6AD1; Device: SBL-3; Device: LS-313 MF30; Device: AT LISA tri 839 MP; Device: ART; Device: LS-313 MF30T

Detailed Description

This study is a prospective randomized controlled trial to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses, the outcome measurements include postoperative visual acuity, visual quality and complications. Patients enrolled in the study will be randomized to receive one of the Multifocal Intraocular Lenses mentioned above, and the clinical outcomes of each Multifocal Intraocular Lens will be assessed at several visits: 1 day, 1 week, 1 month, 3 months and months post-operatively.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AYong Yu, MD. PhD.; Phone Number: +86-0577-88068880; Email: yaybetter@hotmail.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The Eye Hispital of Wenzhou Medical University
      • Contact: Anpeng Pan, MD.OD.; Phone Number: +86-577-88068809; Email: pananpeng@126.com
      • Sub-Investigator: Shuangqian Zhu, MD.
      • Sub-Investigator: Kaijing Zhou, MD.PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 40 to 80 years old, either gender;
• Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
• Willing to undergo second eye surgery within 7 days after first eye surgery;
• The potential postoperative visual acuity of 20/40 or better in both eyes;
• Preoperative measurement of corneal astigmatism indicate the subjects are suitable for multifocal intraocular lenses implantation;
• Capability to understand the informed consent and willing and able to attend study

Exclusion Criteria:

• Preexisting ocular diseases or conditions other than age related cataracts, have contraindications for cataract surgery;
• Preexisting systemic diseases or conditions that may confound the results of the study;
• Previous ocular surgery history or ocular trauma that may confound the results of the study;
• Require combined surgery that may confound the results of the study;
• Previous participation in other clinical trial within 30 days of this study start;
• Systemic or ocular medications that may confound the outcome of the intervention
• Pregnant, lactating, or planning to become pregnant during the course of the trial;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SN6AD1 group; Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs	Device: SN6AD1; Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
Active Comparator: SBL-3 group; Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs	Device: SBL-3; Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
Active Comparator: LS-313 MF30 group; Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs	Device: LS-313 MF30; Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
Active Comparator: AT LISA tri 839 MP group; Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs	Device: AT LISA tri 839 MP; Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
Active Comparator: ART group; Bilateral cataract surgery with implantation of ART toric multifocal IOLs	Device: ART; Bilateral cataract surgery with implantation of ART toric multifocal IOLs
Active Comparator: LS-313 MF30T group; Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs	Device: LS-313 MF30T; Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Visual Acuity (UCVA) at Distance, Near		3 months after surgery
Best distance corrected Visual Acuity at Distance, Near		3 months after surgery
Defocus curve	measured with distance correction for unilateral and bilateral	3 months after surgery
Contrast sensitivity	measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)	3 months after surgery
Ocular aberration	measured with a custom-built aberrometer	3 months after surgery
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II		3 months after surgery
Modulation Transfer Function (MTF) cut-off measured by OQAS II		3 months after surgery
Strehl Ratio measured by OQAS II		3 months after surgery
Quality of Vision (QoV) Questionnaire score		3 months after surgery
Catquest- 9SF Questionnaire score		3 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Refractive error after surgery	3 months after surgery
Rate of Posterior Capsule Opacification	6 months after surgery
Rate of Nd:YAG Laser Posterior Capsulotomy	6 months after surgery
Rate of Spectacle Independence	6 months after surgery

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: AYong Yu, MD. PhD., Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 7, 2016
• First Posted (Estimated): February 10, 2016

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Multifocal Intraocular Lenses; bilateral implantation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MIOLs2016

Plan for Individual participant data (IPD)

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