NCT02678962

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2016Jun 2026

First Submitted

Initial submission to the registry

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

10.3 years

First QC Date

February 1, 2016

Last Update Submit

July 22, 2024

Conditions

Cataract

Keywords

Multifocal Intraocular Lensesbilateral implantation

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (4)

  • 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

Study Arms (6)

SN6AD1 group

ACTIVE COMPARATOR

Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

Device: SN6AD1

SBL-3 group

ACTIVE COMPARATOR

Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

Device: SBL-3

LS-313 MF30 group

ACTIVE COMPARATOR

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

Device: LS-313 MF30

AT LISA tri 839 MP group

ACTIVE COMPARATOR

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

Device: AT LISA tri 839 MP

ART group

ACTIVE COMPARATOR

Bilateral cataract surgery with implantation of ART toric multifocal IOLs

Device: ART

LS-313 MF30T group

ACTIVE COMPARATOR

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

Device: LS-313 MF30T

Interventions

SN6AD1DEVICE

Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

SN6AD1 group
SBL-3DEVICE

Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

SBL-3 group
LS-313 MF30DEVICE

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

LS-313 MF30 group
AT LISA tri 839 MPDEVICE

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

AT LISA tri 839 MP group
ARTDEVICE

Bilateral cataract surgery with implantation of ART toric multifocal IOLs

ART group
LS-313 MF30TDEVICE

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

LS-313 MF30T group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • AYong Yu, MD. PhD.

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AYong Yu, MD. PhD.

CONTACT

+86-0577-88068880yaybetter@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 10, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)