Back to resultsComparison of Outcomes With Multifocal Intraocular Lenses (COMIL)
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SN6AD1
SBL-3
LS-313 MF30
AT LISA tri 839 MP
ART
LS-313 MF30T
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Multifocal Intraocular Lenses, bilateral implantation
Eligibility 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;
Sites / Locations
- The Eye Hispital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
SN6AD1 group
SBL-3 group
LS-313 MF30 group
AT LISA tri 839 MP group
ART group
LS-313 MF30T group
Arm Description
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
Bilateral cataract surgery with implantation of ART toric multifocal IOLs
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
Outcomes
Primary Outcome Measures
Uncorrected Visual Acuity (UCVA) at Distance, Near
Best distance corrected Visual Acuity at Distance, Near
Defocus curve
measured with distance correction for unilateral and bilateral
Contrast sensitivity
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
Ocular aberration
measured with a custom-built aberrometer
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
Modulation Transfer Function (MTF) cut-off measured by OQAS II
Strehl Ratio measured by OQAS II
Quality of Vision (QoV) Questionnaire score
Catquest- 9SF Questionnaire score
Secondary Outcome Measures
Refractive error after surgery
Rate of Posterior Capsule Opacification
Rate of Nd:YAG Laser Posterior Capsulotomy
Rate of Spectacle Independence
Full Information
NCT ID
NCT02678962
First Posted
February 1, 2016
Last Updated
October 4, 2021
Sponsor
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02678962
Brief Title
Comparison of Outcomes With Multifocal Intraocular Lenses
Acronym
COMIL
Official Title
Comparison of Outcomes With Multifocal Intraocular Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Multifocal Intraocular Lenses, bilateral implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SN6AD1 group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
Arm Title
SBL-3 group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
Arm Title
LS-313 MF30 group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
Arm Title
AT LISA tri 839 MP group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
Arm Title
ART group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of ART toric multifocal IOLs
Arm Title
LS-313 MF30T group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
Intervention Type
Device
Intervention Name(s)
SN6AD1
Intervention Description
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
Intervention Type
Device
Intervention Name(s)
SBL-3
Intervention Description
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
Intervention Type
Device
Intervention Name(s)
LS-313 MF30
Intervention Description
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
Intervention Type
Device
Intervention Name(s)
AT LISA tri 839 MP
Intervention Description
Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
Intervention Type
Device
Intervention Name(s)
ART
Intervention Description
Bilateral cataract surgery with implantation of ART toric multifocal IOLs
Intervention Type
Device
Intervention Name(s)
LS-313 MF30T
Intervention Description
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity (UCVA) at Distance, Near
Time Frame
3 months after surgery
Title
Best distance corrected Visual Acuity at Distance, Near
Time Frame
3 months after surgery
Title
Defocus curve
Description
measured with distance correction for unilateral and bilateral
Time Frame
3 months after surgery
Title
Contrast sensitivity
Description
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
Time Frame
3 months after surgery
Title
Ocular aberration
Description
measured with a custom-built aberrometer
Time Frame
3 months after surgery
Title
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
Time Frame
3 months after surgery
Title
Modulation Transfer Function (MTF) cut-off measured by OQAS II
Time Frame
3 months after surgery
Title
Strehl Ratio measured by OQAS II
Time Frame
3 months after surgery
Title
Quality of Vision (QoV) Questionnaire score
Time Frame
3 months after surgery
Title
Catquest- 9SF Questionnaire score
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Refractive error after surgery
Time Frame
3 months after surgery
Title
Rate of Posterior Capsule Opacification
Time Frame
6 months after surgery
Title
Rate of Nd:YAG Laser Posterior Capsulotomy
Time Frame
6 months after surgery
Title
Rate of Spectacle Independence
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AYong Yu, MD. PhD.
Phone
+86-0577-88068880
Email
yaybetter@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYong Yu, MD. PhD.
Organizational Affiliation
Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eye Hispital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anpeng Pan, MD.OD.
Phone
+86-577-88068809
Email
pananpeng@126.com
First Name & Middle Initial & Last Name & Degree
Shuangqian Zhu, MD.
First Name & Middle Initial & Last Name & Degree
Kaijing Zhou, MD.PhD.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Outcomes With Multifocal Intraocular Lenses
We'll reach out to this number within 24 hrs