Comparison of Outcomes With Multifocal Intraocular Lenses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Outcomes With Multifocal Intraocular Lenses

Conditions
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Cataract

Intervention / Treatment
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* Device: SN6AD1
* Device: SBL-3
* Device: LS-313 MF30
* Device: AT LISA tri 839 MP
* Device: ART
* Device: LS-313 MF30T


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SN6AD1 group<br>Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs | Device: SN6AD1<br>* Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs<br>|
| Active Comparator: SBL-3 group<br>Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs | Device: SBL-3<br>* Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs<br>|
| Active Comparator: LS-313 MF30 group<br>Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs | Device: LS-313 MF30<br>* Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs<br>|
| Active Comparator: AT LISA tri 839 MP group<br>Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs | Device: AT LISA tri 839 MP<br>* Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs<br>|
| Active Comparator: ART group<br>Bilateral cataract surgery with implantation of ART toric multifocal IOLs | Device: ART<br>* Bilateral cataract surgery with implantation of ART toric multifocal IOLs<br>|
| Active Comparator: LS-313 MF30T group<br>Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs | Device: LS-313 MF30T<br>* Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 6 months after surgery | 
| Rate of Spectacle Independence |  | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multifocal Intraocular Lenses, bilateral implantation