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NCT Number: NCT02678962

Comparison of Outcomes With Multifocal Intraocular Lenses

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Anpeng Pan, MD.OD.

CONTACT

[email protected]

+86-577-88068809

Kaijing Zhou, MD.PhD.

SUB_INVESTIGATOR

Shuangqian Zhu, MD.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

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

    Time frame: 3 months after surgery

    measured with distance correction for unilateral and bilateral

  4. Contrast sensitivity

    Time frame: 3 months after surgery

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

  5. Ocular aberration

    Time frame: 3 months after surgery

    measured with a custom-built aberrometer

  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

Study contacts

Contact information is provided by the study sponsor or research team.

AYong Yu, MD. PhD.

CONTACT

[email protected]

+86-0577-88068880

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Acronym: COMIL

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2016
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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