COMIL: Comparison of Outcomes With Multifocal Intraocular Lenses
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Uncorrected Visual Acuity (UCVA) at Distance, Near [3 months after surgery]
- Best distance corrected Visual Acuity at Distance, Near [3 months after surgery]
- Defocus curve [3 months after surgery]
measured with distance correction for unilateral and bilateral
- Contrast sensitivity [3 months after surgery]
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
- Ocular aberration [3 months after surgery]
measured with a custom-built aberrometer
- Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II [3 months after surgery]
- Modulation Transfer Function (MTF) cut-off measured by OQAS II [3 months after surgery]
- Strehl Ratio measured by OQAS II [3 months after surgery]
- Quality of Vision (QoV) Questionnaire score [3 months after surgery]
- Catquest- 9SF Questionnaire score [3 months after surgery]
Secondary Outcome Measures
- Refractive error after surgery [3 months after surgery]
- Rate of Posterior Capsule Opacification [6 months after surgery]
- Rate of Nd:YAG Laser Posterior Capsulotomy [6 months after surgery]
- Rate of Spectacle Independence [6 months after surgery]
Eligibility Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Eye Hispital of Wenzhou Medical University | Wenzhou | Zhejiang | China | 325000 |
Sponsors and Collaborators
- Wenzhou Medical University
Investigators
- Principal Investigator: AYong Yu, MD. PhD., Wenzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIOLs2016