CataractCOMILNCT02678962
Comparison of Outcomes With Multifocal Intraocular Lenses
A study testing SN6AD1, SBL-3 and LS-313 MF30 in people with Cataract, run by Wenzhou Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- SN6AD1, SBL-3 and LS-313 MF30
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Anpeng Pan, MD.OD., +86-577-88068809, pananpeng@126.com
Shuangqian Zhu, MD.
About this study
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.
- Conditions
- Cataract
- Being tested
- SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART
- Keywords
- Multifocal Intraocular Lenses, bilateral implantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN6AD1Device
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
SBL-3Device
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
LS-313 MF30Device
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
AT LISA tri 839 MPDevice
Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
ARTDevice
Bilateral cataract surgery with implantation of ART toric multifocal IOLs
LS-313 MF30TDevice
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
| Study group | Role | What they receive |
|---|---|---|
| SN6AD1 group | Active comparator | Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs Receives: Device: SN6AD1 |
| SBL-3 group | Active comparator | Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs Receives: Device: SBL-3 |
| LS-313 MF30 group | Active comparator | Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs Receives: Device: LS-313 MF30 |
| AT LISA tri 839 MP group | Active comparator | Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs Receives: Device: AT LISA tri 839 MP |
| ART group | Active comparator | Bilateral cataract surgery with implantation of ART toric multifocal IOLs Receives: Device: ART |
| LS-313 MF30T group | Active comparator | Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs Receives: Device: LS-313 MF30T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity (UCVA) at Distance, Near
Measured: 3 months after surgery
Best distance corrected Visual Acuity at Distance, Near
Measured: 3 months after surgery
Defocus curve
measured with distance correction for unilateral and bilateral
Measured: 3 months after surgery
Contrast sensitivity
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
Measured: 3 months after surgery
Ocular aberration
measured with a custom-built aberrometer
Measured: 3 months after surgery
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
Measured: 3 months after surgery
Modulation Transfer Function (MTF) cut-off measured by OQAS II
Measured: 3 months after surgery
Strehl Ratio measured by OQAS II
Measured: 3 months after surgery
Quality of Vision (QoV) Questionnaire score
Measured: 3 months after surgery
Catquest- 9SF Questionnaire score
Measured: 3 months after surgery
Secondary outcomes (4)
Refractive error after surgery
Measured: 3 months after surgery
Rate of Posterior Capsule Opacification
Measured: 6 months after surgery
Rate of Nd:YAG Laser Posterior Capsulotomy
Measured: 6 months after surgery
Rate of Spectacle Independence
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A-Yong Yu, Wenzhou Medical University
- Investigators
- AYong Yu, MD. PhD., Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678962
- Sponsor's protocol ID
- MIOLs2016
- Acronym
- COMIL
- Status last verified
- Jul 2024
- First submitted
- 1 Feb 2016
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes With Multifocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT02678962
- Acronym / sponsor ID
- COMIL / MIOLs2016
- Conditions
- Cataract
- Keywords
- Multifocal Intraocular Lenses, bilateral implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SN6AD1 group | Active comparator | Device: SN6AD1Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs |
| SBL-3 group | Active comparator | Device: SBL-3Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs |
| LS-313 MF30 group | Active comparator | Device: LS-313 MF30Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs |
| AT LISA tri 839 MP group | Active comparator | Device: AT LISA tri 839 MPBilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs |
| ART group | Active comparator | Device: ARTBilateral cataract surgery with implantation of ART toric multifocal IOLs |
| LS-313 MF30T group | Active comparator | Device: LS-313 MF30TBilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SN6AD1Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs | Device | SN6AD1 group |
| SBL-3Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs | Device | SBL-3 group |
| LS-313 MF30Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs | Device | LS-313 MF30 group |
| AT LISA tri 839 MPBilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs | Device | AT LISA tri 839 MP group |
| ARTBilateral cataract surgery with implantation of ART toric multifocal IOLs | Device | ART group |
| LS-313 MF30TBilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs | Device | LS-313 MF30T group |
Primary outcome
Uncorrected Visual Acuity (UCVA) at Distance, Near
Time frame: 3 months after surgery
Best distance corrected Visual Acuity at Distance, Near
Time frame: 3 months after surgery
Defocus curve
Time frame: 3 months after surgery
measured with distance correction for unilateral and bilateral
Contrast sensitivity
Time frame: 3 months after surgery
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
Ocular aberration
Time frame: 3 months after surgery
measured with a custom-built aberrometer
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
Time frame: 3 months after surgery
Modulation Transfer Function (MTF) cut-off measured by OQAS II
Time frame: 3 months after surgery
Strehl Ratio measured by OQAS II
Time frame: 3 months after surgery
Quality of Vision (QoV) Questionnaire score
Time frame: 3 months after surgery
Catquest- 9SF Questionnaire score
Time frame: 3 months after surgery
4 secondary outcomes
Refractive error after surgery
Time frame: 3 months after surgery
Rate of Posterior Capsule Opacification
Time frame: 6 months after surgery
Rate of Nd:YAG Laser Posterior Capsulotomy
Time frame: 6 months after surgery
Rate of Spectacle Independence
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYong Yu, MD. PhD. principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SN6AD1, SBL-3 and LS-313 MF30 in people with Cataract, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AYong Yu, MD. PhD. (+86-0577-88068880, yaybetter@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuity (UCVA) at Distance, Near (time frame: 3 months after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.