Comparison of Outcomes With Multifocal Intraocular Lenses

Not Applicable

Recruiting

• Conditions: Cataract
• Interventions: Device: ART; Device: SN6AD1; Device: SBL-3; Device: LS-313 MF30T; Device: LS-313 MF30; Device: AT LISA tri 839 MP

• Registration Number: NCT02678962
• Lead Sponsor: Wenzhou Medical University

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-07
• Study First Posted: 2016-02-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ART group	ART	Bilateral cataract surgery with implantation of ART toric multifocal IOLs
SN6AD1 group	SN6AD1	Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
SBL-3 group	SBL-3	Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
LS-313 MF30T group	LS-313 MF30T	Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
LS-313 MF30 group	LS-313 MF30	Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
AT LISA tri 839 MP group	AT LISA tri 839 MP	Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs

Primary Outcome Measures

Name	Time	Method
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
Uncorrected Visual Acuity (UCVA) at Distance, Near	3 months after surgery
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
Contrast sensitivity	3 months after surgery	measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
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

Name	Time	Method
Rate of Spectacle Independence	6 months after surgery
Rate of Posterior Capsule Opacification	6 months after surgery
Refractive error after surgery	3 months after surgery
Rate of Nd:YAG Laser Posterior Capsulotomy	6 months after surgery

Trial Locations

Locations (1)

The Eye Hispital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China