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RecruitingNCT02678962COMILUpdated Jul 23, 2024

Comparison of Outcomes With Multifocal Intraocular Lenses

An interventional study of SN6AD1 and SBL-3 in Cataract, sponsored by Wenzhou Medical University. Recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract

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Keywords

  • Multifocal Intraocular Lenses
  • bilateral implantation
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 90 is above the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and willing and able to attend study

Exclusion criteria

Exclusion Criteria:

  • Preexisting ocular diseases or conditions other than age related cataracts, have 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;
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    SN6AD1 group

    Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

    Device: SN6AD1

  • Active comparator
    SBL-3 group

    Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

    Device: SBL-3

  • Active comparator
    LS-313 MF30 group

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

    Device: LS-313 MF30

  • 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

  • Active comparator
    ART group

    Bilateral cataract surgery with implantation of ART toric multifocal IOLs

    Device: ART

  • Active comparator
    LS-313 MF30T group

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

    Device: LS-313 MF30T

Interventions

  • DeviceSN6AD1

    Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

  • DeviceSBL-3

    Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

  • DeviceLS-313 MF30

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

  • DeviceAT LISA tri 839 MP

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

  • DeviceART

    Bilateral cataract surgery with implantation of ART toric multifocal IOLs

  • DeviceLS-313 MF30T

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

06

What researchers measure

Primary outcomes

  1. Uncorrected Visual Acuity (UCVA) at Distance, Near

    Time frame: 3 months after surgery

  2. Best distance corrected Visual Acuity at Distance, Near

    Time frame: 3 months after surgery

  3. Defocus curve

    measured with distance correction for unilateral and bilateral

    Time frame: 3 months after surgery

  4. Contrast sensitivity

    measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)

    Time frame: 3 months after surgery

  5. Ocular aberration

    measured with a custom-built aberrometer

    Time frame: 3 months after surgery

  6. Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II

    Time frame: 3 months after surgery

  7. Modulation Transfer Function (MTF) cut-off measured by OQAS II

    Time frame: 3 months after surgery

  8. Strehl Ratio measured by OQAS II

    Time frame: 3 months after surgery

  9. Quality of Vision (QoV) Questionnaire score

    Time frame: 3 months after surgery

  10. Catquest- 9SF Questionnaire score

    Time frame: 3 months after surgery

Secondary outcomes

  1. Refractive error after surgery

    Time frame: 3 months after surgery

  2. Rate of Posterior Capsule Opacification

    Time frame: 6 months after surgery

  3. Rate of Nd:YAG Laser Posterior Capsulotomy

    Time frame: 6 months after surgery

  4. Rate of Spectacle Independence

    Time frame: 6 months after surgery

07

Study locations

1 of 1 sites recruiting
  • The Eye Hispital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
    Recruiting
    • Anpeng Pan, MD.OD. · Contactpananpeng@126.com · +86-577-88068809
    • Shuangqian Zhu, MD. · Sub investigator
    • Kaijing Zhou, MD.PhD. · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2016, a primary completion of Jun 2026 and a completion of Jun 2026. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2016
First posted
Feb 10, 2016
Start
Feb 2016
Primary completionEst.
Jun 2026
CompletionEst.
Jun 2026
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02678962
Lead sponsor
Wenzhou Medical University
Responsible party
A-Yong Yu (Clinical Professor, Wenzhou Medical University) — Principal investigator
First posted
Feb 10, 2016
Start date
Feb 2016
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jul 23, 2024

Study contacts

AYong Yu, MD. PhD.
Contact
yaybetter@hotmail.com
+86-0577-88068880
AYong Yu, MD. PhD.
principal investigator · Wenzhou Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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