Comparison of Outcomes With Multifocal Intraocular Lenses (COMIL)

July 22, 2024 updated by: A-Yong Yu, Wenzhou Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The Eye Hispital of Wenzhou Medical University
        • Contact:
        • Sub-Investigator:
          • Shuangqian Zhu, MD.
        • Sub-Investigator:
          • Kaijing Zhou, MD.PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity (UCVA) at Distance, Near
Time Frame: 3 months after surgery
3 months after surgery
Best distance corrected Visual Acuity at Distance, Near
Time Frame: 3 months after surgery
3 months after surgery
Defocus curve
Time Frame: 3 months after surgery
measured with distance correction for unilateral and bilateral
3 months after surgery
Contrast sensitivity
Time Frame: 3 months after surgery
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
3 months after surgery
Ocular aberration
Time Frame: 3 months after surgery
measured with a custom-built aberrometer
3 months after surgery
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
Time Frame: 3 months after surgery
3 months after surgery
Modulation Transfer Function (MTF) cut-off measured by OQAS II
Time Frame: 3 months after surgery
3 months after surgery
Strehl Ratio measured by OQAS II
Time Frame: 3 months after surgery
3 months after surgery
Quality of Vision (QoV) Questionnaire score
Time Frame: 3 months after surgery
3 months after surgery
Catquest- 9SF Questionnaire score
Time Frame: 3 months after surgery
3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Refractive error after surgery
Time Frame: 3 months after surgery
3 months after surgery
Rate of Posterior Capsule Opacification
Time Frame: 6 months after surgery
6 months after surgery
Rate of Nd:YAG Laser Posterior Capsulotomy
Time Frame: 6 months after surgery
6 months after surgery
Rate of Spectacle Independence
Time Frame: 6 months after surgery
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wenzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: AYong Yu, MD. PhD., Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIOLs2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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