Comparison of the Visual Performance After Implantation of Multifocal Lens

Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens(AT Lisa Tri 839MP) and Two Bifocal Intraocular Lenses(ReSTOR +2.5/+ 3.0D and Diff-aay)

This is a prospective, consecutive, nonrandomized,comparative study. Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens and Two Bifocal Intraocular Lenses

Study Overview

• Status: Unknown
• Conditions: Intraocular Lens
• Intervention / Treatment: Procedure: bifocal lens 1; Procedure: bifocal lens 2; Procedure: bifocal lens 3; Procedure: trifocal lens

Detailed Description

Multifocal intraocular lenses were introduced in the 1980s and have the benefit of promoting near and far vision simultaneous. However, these multifocal lenses have the disadvantages, including lower contrast sensitivity(CS) and visual discomfort, such as halos, glares and starburst, et al. Therefore, careful patient selection is crucial to achieve good postoperative results. The purpose of this study was to compare the visual outcomes and subjective visual quality between bifocal intraocular Lens(ReSTOR +2.5/+ 3.0D and Diff-aay) and trifocal intraocular Lens(AT Lisa tri 839MP). This prospective, nonrandomized, consecutive, comparative study included the assessment of 60 patients implanted with multifocal intraocular lens. visual acuity was tested in all cases. Ophthalmological evaluation included the measurement of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected near visual acuity (UNVA), and uncorrected intermediate visual acuity (UIVA), the analysis of contrast sensitivity (CS), visual defocus curve, spectacle independence, patient satisfaction, residual sphere, spherical equivalent (SE), cylinder and complications.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Wensheng Li
    • Contact: Hua Fan; Phone Number: +8618650424985 +8618988761617; Email: fanhua1116@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

cataract patients

Description

Inclusion Criteria:

• cataract

Exclusion Criteria:

• existence of any corneal disease;
• previous eye surgery;
• illiteracy;
• previous refractive surgery;
• expected postoperative corneal astigmatism more than 1.00D;
• higer-order aberration more than 0.3;
• spherical aberration more than 0.3μm;
• intraoperative or postoperative complications.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trifocal lens; trifocal lens implantation(AT Lisa tri 839MP)	Procedure: bifocal lens 1; phacoemusification +bifocal lens(Diff-aay) implantation; Procedure: bifocal lens 2; phacoemusification +bifocal lens (ReSTOR +3.0D) implantation; Procedure: bifocal lens 3; phacoemusification +bifocal lens (ReSTOR +2.5D) implantation
bifocal lens 1; bifocal lens implantation(Diff-aay)	Procedure: bifocal lens 2; phacoemusification +bifocal lens (ReSTOR +3.0D) implantation; Procedure: bifocal lens 3; phacoemusification +bifocal lens (ReSTOR +2.5D) implantation; Procedure: trifocal lens; phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation
bifocal lens 2; bifocal lens implantation(ReSTOR +3.0D)	Procedure: bifocal lens 1; phacoemusification +bifocal lens(Diff-aay) implantation; Procedure: bifocal lens 3; phacoemusification +bifocal lens (ReSTOR +2.5D) implantation; Procedure: trifocal lens; phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation
bifocal lens 3; bifocal lens implantation(ReSTOR +2.5D)	Procedure: bifocal lens 1; phacoemusification +bifocal lens(Diff-aay) implantation; Procedure: bifocal lens 2; phacoemusification +bifocal lens (ReSTOR +3.0D) implantation; Procedure: trifocal lens; phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected distance visual acuity	Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).	3 months after surgery
Uncorrected near visual acuity	Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).	3 months after surgery
Uncorrected intermediate visual acuity	Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).	3 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of vision	Quality of vision was measured using the National Eye Institute Visual Function Questionnaire (NEI VFQ)-25. The NEI-VFQ was developed at the RAND under the sponsorship of the NEI; it provides a self-reported measure of visual function.	3 months after surgery

Collaborators and Investigators

• Sponsor: Aier School of Ophthalmology, Central South University
• Investigators: Study Director: Wensheng Li, Shanghai Aier Eye Hosptial

Publications and helpful links

General Publications

• de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
• Gundersen KG, Potvin R. Comparison of visual outcomes after implantation of diffractive trifocal toric intraocular lens and a diffractive apodized bifocal toric intraocular lens. Clin Ophthalmol. 2016 Mar 17;10:455-61. doi: 10.2147/OPTH.S103375. eCollection 2016.
• Xu Z, Cao D, Chen X, Wu S, Wang X, Wu Q. Comparison of clinical performance between trifocal and bifocal intraocular lenses: A meta-analysis. PLoS One. 2017 Oct 26;12(10):e0186522. doi: 10.1371/journal.pone.0186522. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 2, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SHIRB2018016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results
• IPD Sharing Time Frame: After this study is finished the data will become available for 1year.
• IPD Sharing Access Criteria: The analytical data will be accessed in published articles.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No