Health TrialsbyHealthPanel

Comparison of Outcomes With Multifocal Intraocular Lenses

ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorWenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SN6AD1

    Device

    Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

  • SBL-3

    Device

    Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

  • LS-313 MF30

    Device

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

  • AT LISA tri 839 MP

    Device

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

  • ART

    Device

    Bilateral cataract surgery with implantation of ART toric multifocal IOLs

  • LS-313 MF30T

    Device

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

Treatment groups

90 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: SN6AD1 groupActive comparator 1 intervention
Group B: SBL-3 groupActive comparator 1 intervention
Group C: LS-313 MF30 groupActive comparator 1 intervention
Group D: AT LISA tri 839 MP groupActive comparator 1 intervention
Group E: ART groupActive comparator 1 intervention
Group F: LS-313 MF30T groupActive comparator 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
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