Comparison of Outcomes With Multifocal Intraocular Lenses

Cataract Clinical Trial

— COMIL  

Official title:

Comparison of Outcomes With Multifocal Intraocular Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678962
• Other study ID #: MIOLs2016
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Wenzhou Medical University
• Contact: AYong Yu, MD. PhD.
• Phone: +86-0577-88068880
• Email: yaybetter[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• SN6AD1
Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
• SBL-3
Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
• LS-313 MF30
Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
• AT LISA tri 839 MP
Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
• ART
Bilateral cataract surgery with implantation of ART toric multifocal IOLs
• LS-313 MF30T
Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs

Locations

Country	Name	City	State
China	The Eye Hispital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Visual Acuity (UCVA) at Distance, Near		3 months after surgery
Primary	Best distance corrected Visual Acuity at Distance, Near		3 months after surgery
Primary	Defocus curve	measured with distance correction for unilateral and bilateral	3 months after surgery
Primary	Contrast sensitivity	measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)	3 months after surgery
Primary	Ocular aberration	measured with a custom-built aberrometer	3 months after surgery
Primary	Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II		3 months after surgery
Primary	Modulation Transfer Function (MTF) cut-off measured by OQAS II		3 months after surgery
Primary	Strehl Ratio measured by OQAS II		3 months after surgery
Primary	Quality of Vision (QoV) Questionnaire score		3 months after surgery
Primary	Catquest- 9SF Questionnaire score		3 months after surgery
Secondary	Refractive error after surgery		3 months after surgery
Secondary	Rate of Posterior Capsule Opacification		6 months after surgery
Secondary	Rate of Nd:YAG Laser Posterior Capsulotomy		6 months after surgery
Secondary	Rate of Spectacle Independence		6 months after surgery