Comparison of Outcomes With Multifocal Intraocular Lenses (COMIL)

Wenzhou Medical University

Status: Enrolling

Conditions: Cataract

Treatments: Device: LS-313 MF30T; Device: ART; Device: SBL-3; Device: LS-313 MF30; Device: AT LISA tri 839 MP; Device: SN6AD1

Study type: Interventional

Funder types: Other

Identifiers

NCT02678962

MIOLs2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 6 patient groups

SN6AD1 group

Active Comparator group

Description:

Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

Treatment:

Device: SN6AD1

SBL-3 group

Active Comparator group

Description:

Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

Treatment:

Device: SBL-3

LS-313 MF30 group

Active Comparator group

Description:

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

Treatment:

Device: LS-313 MF30

AT LISA tri 839 MP group

Active Comparator group

Description:

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

Treatment:

Device: AT LISA tri 839 MP

ART group

Active Comparator group

Description:

Bilateral cataract surgery with implantation of ART toric multifocal IOLs

Treatment:

Device: ART

LS-313 MF30T group

Active Comparator group

Description:

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

Treatment:

Device: LS-313 MF30T