Comparison of Outcomes With Multifocal Intraocular Lenses

NCT ID: NCT02678962

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SN6AD1 group

Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

Group Type ACTIVE_COMPARATOR

SN6AD1

Intervention Type DEVICE

Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

SBL-3 group

Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

Group Type ACTIVE_COMPARATOR

SBL-3

Intervention Type DEVICE

Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

LS-313 MF30 group

Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs

Group Type ACTIVE_COMPARATOR

LS-313 MF30

Intervention Type DEVICE

Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs

AT LISA tri 839 MP group

Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs

Group Type ACTIVE_COMPARATOR

AT LISA tri 839 MP

Intervention Type DEVICE

Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs

ART group

Bilateral cataract surgery with implantation of ART toric multifocal IOLs

Group Type ACTIVE_COMPARATOR

ART

Intervention Type DEVICE

Bilateral cataract surgery with implantation of ART toric multifocal IOLs

LS-313 MF30T group

Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs

Group Type ACTIVE_COMPARATOR

LS-313 MF30T

Intervention Type DEVICE

Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs

Interventions

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SN6AD1

Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

Intervention Type DEVICE

SBL-3

Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

Intervention Type DEVICE

LS-313 MF30

Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs

Intervention Type DEVICE

AT LISA tri 839 MP

Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs

Intervention Type DEVICE

ART

Bilateral cataract surgery with implantation of ART toric multifocal IOLs

Intervention Type DEVICE

LS-313 MF30T

Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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A-Yong Yu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYong Yu, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

Locations

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The Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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AYong Yu, MD. PhD.

Role: CONTACT

+86-0577-88068880

Facility Contacts

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Anpeng Pan, MD.OD.

Role: primary

+86-577-88068809

Other Identifiers

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MIOLs2016

Identifier Type: -

Identifier Source: org_study_id

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