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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SN6AD1 group | Active Comparator | Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs |
|
| SBL-3 group | Active Comparator | Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs |
|
| LS-313 MF30 group | Active Comparator | Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs |
|
| AT LISA tri 839 MP group | Active Comparator | Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs |
|
| ART group | Active Comparator | Bilateral cataract surgery with implantation of ART toric multifocal IOLs |
|
| LS-313 MF30T group | Active Comparator | Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SN6AD1 | Device | Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | measured with distance correction for unilateral and bilateral | 3 months after surgery |
| Contrast sensitivity | measured with CSV-1000HGT(VECTOR VISION, Greenville, OH) | 3 months after surgery |
| Ocular aberration | measured with a custom-built aberrometer | 3 months after surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive error after surgery | 3 months after surgery | |
| Rate of Posterior Capsule Opacification | 6 months after surgery | |
| Rate of Nd:YAG Laser Posterior Capsulotomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AYong Yu, MD. PhD. | Contact | +86-0577-88068880 | yaybetter@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| AYong Yu, MD. PhD. | Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Hispital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| 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 |
|
| 3 months after surgery |
| 6 months after surgery |
| Rate of Spectacle Independence | 6 months after surgery |