Comparison of the Visual Performance After Implantation of Multifocal Lens

Intraocular Lens Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586271
• Other study ID #: SHIRB2018016
• Status: Recruiting
• Start date: August 2, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: May 2018
• Source: Aier School of Ophthalmology, Central South University
• Contact: Hua Fan
• Phone: +8618988761617
• Email: fanhua1116[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Lens

Intervention

Procedure:
• trifocal lens
phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation
• bifocal lens 1
phacoemusification +bifocal lens(Diff-aay) implantation
• bifocal lens 2
phacoemusification +bifocal lens (ReSTOR +3.0D) implantation
• bifocal lens 3
phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

Locations

Country	Name	City	State
China	Wensheng Li	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

de Medeiros AL, de Araújo 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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