Comparison of the Visual Performance After Implantation of Multifocal Lens

• Conditions: Intraocular Lens
• Interventions: Procedure: trifocal lens; Procedure: bifocal lens 2; Procedure: bifocal lens 1; Procedure: bifocal lens 3

• Registration Number: NCT03586271
• Lead Sponsor: Aier School of Ophthalmology, Central South University

Brief 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

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 Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Study First Posted: 2018-07-13
• Last Update Posted: 2018-07-13
• Study Start: 2018-08-02
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bifocal lens 1	trifocal lens	bifocal lens implantation(Diff-aay)
bifocal lens 1	bifocal lens 2	bifocal lens implantation(Diff-aay)
bifocal lens 1	bifocal lens 3	bifocal lens implantation(Diff-aay)
bifocal lens 2	trifocal lens	bifocal lens implantation(ReSTOR +3.0D)
bifocal lens 2	bifocal lens 1	bifocal lens implantation(ReSTOR +3.0D)
bifocal lens 3	bifocal lens 2	bifocal lens implantation(ReSTOR +2.5D)
trifocal lens	bifocal lens 1	trifocal lens implantation(AT Lisa tri 839MP)
trifocal lens	bifocal lens 2	trifocal lens implantation(AT Lisa tri 839MP)
trifocal lens	bifocal lens 3	trifocal lens implantation(AT Lisa tri 839MP)
bifocal lens 2	bifocal lens 3	bifocal lens implantation(ReSTOR +3.0D)
bifocal lens 3	trifocal lens	bifocal lens implantation(ReSTOR +2.5D)
bifocal lens 3	bifocal lens 1	bifocal lens implantation(ReSTOR +2.5D)

Primary Outcome Measures

Name	Time	Method
Uncorrected intermediate visual acuity	3 months after surgery	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).
Uncorrected distance visual acuity	3 months after surgery	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).
Uncorrected near visual acuity	3 months after surgery	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).

Trial Locations

Locations (1)

Wensheng Li; 🇨🇳 Shanghai, China