NCT03586271

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 13, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

June 15, 2018

Last Update Submit

July 2, 2018

Conditions

Intraocular Lens

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Quality of vision

    3 months after surgery

Study Arms (4)

trifocal lens

trifocal lens implantation(AT Lisa tri 839MP)

Procedure: bifocal lens 1Procedure: bifocal lens 2Procedure: bifocal lens 3

bifocal lens 1

bifocal lens implantation(Diff-aay)

Procedure: trifocal lensProcedure: bifocal lens 2Procedure: bifocal lens 3

bifocal lens 2

bifocal lens implantation(ReSTOR +3.0D)

Procedure: trifocal lensProcedure: bifocal lens 1Procedure: bifocal lens 3

bifocal lens 3

bifocal lens implantation(ReSTOR +2.5D)

Procedure: trifocal lensProcedure: bifocal lens 1Procedure: bifocal lens 2

Interventions

trifocal lensPROCEDURE

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

bifocal lens 1bifocal lens 2bifocal lens 3
bifocal lens 1PROCEDURE

phacoemusification +bifocal lens(Diff-aay) implantation

bifocal lens 2bifocal lens 3trifocal lens
bifocal lens 2PROCEDURE

phacoemusification +bifocal lens (ReSTOR +3.0D) implantation

bifocal lens 1bifocal lens 3trifocal lens
bifocal lens 3PROCEDURE

phacoemusification +bifocal lens (ReSTOR +2.5D) implantation

bifocal lens 1bifocal lens 2trifocal lens

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cataract patients

You may qualify if:

  • cataract

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wensheng Li

Shanghai, 200000, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29138533BACKGROUND

  • 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.

    PMID: 27051269BACKGROUND

  • 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.

    PMID: 29073156BACKGROUND

Study Officials

  • Wensheng Li

    Shanghai Aier Eye Hosptial

    STUDY DIRECTOR

Central Study Contacts

Hua Fan

CONTACT

+8618988761617fanhua1116@163.com

Wensheng Li

CONTACT

+8618650424985drlws@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 13, 2018

Study Start

August 2, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

July 13, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

all IPD that underlie results

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After this study is finished the data will become available for 1year.
Access Criteria
The analytical data will be accessed in published articles.

Locations

CN(1)