Comparison of the Visual Performance After Implantation of Multifocal Lens

Sponsor
Aier School of Ophthalmology, Central South University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03586271
Collaborator
(none)
60
1
6
10

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: trifocal lens
  • Procedure: bifocal lens 1
  • Procedure: bifocal lens 2
  • Procedure: bifocal lens 3

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Anticipated Study Start Date :
Aug 2, 2018
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm 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: trifocal lens
phacoemusification + trifocal lens(AT Lisa tri 839MP) 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 2

bifocal lens implantation(ReSTOR +3.0D)

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

Procedure: bifocal lens 1
phacoemusification +bifocal lens(Diff-aay) implantation

Procedure: bifocal lens 3
phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 3

bifocal lens implantation(ReSTOR +2.5D)

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

Procedure: bifocal lens 1
phacoemusification +bifocal lens(Diff-aay) implantation

Procedure: bifocal lens 2
phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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).

  3. 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).

Other Outcome Measures

  1. Quality of vision [3 months after surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wensheng Li Shanghai China 200000

Sponsors and Collaborators

  • Aier School of Ophthalmology, Central South University

Investigators

  • Study Director: Wensheng Li, Shanghai Aier Eye Hosptial

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aier School of Ophthalmology, Central South University
ClinicalTrials.gov Identifier:
NCT03586271
Other Study ID Numbers:
  • SHIRB2018016
First Posted:
Jul 13, 2018
Last Update Posted:
Jul 13, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 13, 2018