Comparison of the Visual Performance After Implantation of Multifocal Lens

NCT ID: NCT03586271

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-02

Study Completion Date

2019-02-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Intraocular Lens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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trifocal lens

trifocal lens implantation(AT Lisa tri 839MP)

bifocal lens 1

Intervention Type PROCEDURE

phacoemusification +bifocal lens(Diff-aay) implantation

bifocal lens 2

Intervention Type PROCEDURE

phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

bifocal lens 3

Intervention Type PROCEDURE

phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 1

bifocal lens implantation(Diff-aay)

trifocal lens

Intervention Type PROCEDURE

phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

bifocal lens 2

Intervention Type PROCEDURE

phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

bifocal lens 3

Intervention Type PROCEDURE

phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 2

bifocal lens implantation(ReSTOR +3.0D)

trifocal lens

Intervention Type PROCEDURE

phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

bifocal lens 1

Intervention Type PROCEDURE

phacoemusification +bifocal lens(Diff-aay) implantation

bifocal lens 3

Intervention Type PROCEDURE

phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 3

bifocal lens implantation(ReSTOR +2.5D)

trifocal lens

Intervention Type PROCEDURE

phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

bifocal lens 1

Intervention Type PROCEDURE

phacoemusification +bifocal lens(Diff-aay) implantation

bifocal lens 2

Intervention Type PROCEDURE

phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

Interventions

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trifocal lens

phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation

Intervention Type PROCEDURE

bifocal lens 1

phacoemusification +bifocal lens(Diff-aay) implantation

Intervention Type PROCEDURE

bifocal lens 2

phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

Intervention Type PROCEDURE

bifocal lens 3

phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wensheng Li

Role: STUDY_DIRECTOR

Shanghai Aier Eye Hosptial

Locations

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Wensheng Li

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Fan

Role: CONTACT

+8618988761617 ext. +8618988761617

Wensheng Li

Role: CONTACT

+8618650424985 ext. +8618650424985

Facility Contacts

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Hua Fan

Role: primary

+8618988761617 ext. +8618650424985

Wensheng Li

Role: backup

+8618650424985 ext. +8618650424985

References

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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.

Reference Type BACKGROUND
PMID: 29138533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27051269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29073156 (View on PubMed)

Other Identifiers

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SHIRB2018016

Identifier Type: -

Identifier Source: org_study_id

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