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Comparison of Outcomes With Multifocal Intraocular Lenses (COMIL)

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ClinicalTrials.gov Identifier: NCT02678962
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Cataract Device: SN6AD1 Device: SBL-3 Device: LS-313 MF30 Device: AT LISA tri 839 MP Device: ART Device: LS-313 MF30T Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Outcomes With Multifocal Intraocular Lenses
Study Start Date : February 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: SN6AD1 group
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
Device: SN6AD1
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs

Active Comparator: SBL-3 group
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
Device: SBL-3
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs

Active Comparator: LS-313 MF30 group
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
Device: LS-313 MF30
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs

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

Active Comparator: ART group
Bilateral cataract surgery with implantation of ART toric multifocal IOLs
Device: ART
Bilateral cataract surgery with implantation of ART toric multifocal IOLs

Active Comparator: LS-313 MF30T group
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
Device: LS-313 MF30T
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678962


Contacts
Contact: AYong Yu, MD. PhD. +86-0577-88068880 yaybetter@hotmail.com

Locations
China, Zhejiang
The Eye Hispital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Anpeng Pan, MD.OD.    +86-577-88068809    pananpeng@126.com   
Sub-Investigator: Shuangqian Zhu, MD.         
Sub-Investigator: Kaijing Zhou, MD.PhD.         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: AYong Yu, MD. PhD. Wenzhou Medical University

Responsible Party: A-Yong Yu, Clinical Professor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02678962     History of Changes
Other Study ID Numbers: MIOLs2016
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by A-Yong Yu, Wenzhou Medical University:
Multifocal Intraocular Lenses
bilateral implantation

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases