NCT04913792

Brief Summary

To evaluate the clinical outcomes with an extended range of vision (ERV) IOL based on achromatic diffractive technology.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 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

Study Start

First participant enrolled

November 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 4, 2021

Status Verified

May 1, 2021

Enrollment Period

4.7 years

First QC Date

November 6, 2017

Last Update Submit

May 30, 2021

Conditions

IOLCataract

Keywords

multifocal IOLocular optical qualityabberation

Outcome Measures

Primary Outcomes (1)

  • Uncorrected distance VA（5m，66cm，40cm）

    logarithmic visual acuity chart

    After operation （Month 3）

Secondary Outcomes (3)

  • Questionnaire concerning halo and visual function

    After operation （Month 3）

  • abberation and kappa angle

    After operation （Month 3）

  • MTF cut-of and OSI

    After operation （Month 3）

Study Arms (1)

ZXR00

The ZXR00 group included 30 patients bilaterally implanted with the Tecnis Symfony IOL (Abbott Medical Optics, Inc.)

Device: ZXR00

Interventions

ZXR00DEVICE

This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)

ZXR00

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients were visually significant cataract and were informed about their inclusion in the study and provided written consent.

You may qualify if:

  • visually significant cataract
  • age of 20 years or older
  • preoperative corneal astigmatism of 1.50 diopters (D) or lower.

You may not qualify if:

  • previous ocular surgery
  • active ocular pathology
  • amblyopia
  • systemic or ocular medication that could affect vision
  • subclinical or clinical corneal ectatic disease
  • pupil abnormalities
  • intraoperative complication leading to capsular or zonular abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (6)

  • Millan MS, Vega F. Extended depth of focus intraocular lens: Chromatic performance. Biomed Opt Express. 2017 Aug 31;8(9):4294-4309. doi: 10.1364/BOE.8.004294. eCollection 2017 Sep 1.

    PMID: 28966865RESULT

  • Kaymak H, Hohn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.

    PMID: 27385257RESULT

  • Esteve-Taboada JJ, Dominguez-Vicent A, Del Aguila-Carrasco AJ, Ferrer-Blasco T, Montes-Mico R. Effect of Large Apertures on the Optical Quality of Three Multifocal Lenses. J Refract Surg. 2015 Oct;31(10):666-76. doi: 10.3928/1081597X-20150928-01.

    PMID: 26469074RESULT

  • Attia MSA, Auffarth GU, Kretz FTA, Tandogan T, Rabsilber TM, Holzer MP, Khoramnia R. Clinical Evaluation of an Extended Depth of Focus Intraocular Lens With the Salzburg Reading Desk. J Refract Surg. 2017 Oct 1;33(10):664-669. doi: 10.3928/1081597X-20170621-08.

    PMID: 28991333RESULT

  • Attia MS, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP. Near and intermediate visual and reading performance of patients with a multifocal apodized diffractive intraocular lens using an electronic reading desk. J Cataract Refract Surg. 2016 Apr;42(4):582-90. doi: 10.1016/j.jcrs.2015.11.047.

    PMID: 27113882RESULT

  • Attia MS, Auffarth GU, Khoramnia R, Linz K, Kretz FT. Near and intermediate reading performance of a diffractive trifocal intraocular lens using a reading desk. J Cataract Refract Surg. 2015 Dec;41(12):2707-14. doi: 10.1016/j.jcrs.2015.06.038.

    PMID: 26796451RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • yune zhao, MD

    Wenzhou Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 6, 2017

First Posted

June 4, 2021

Study Start

November 1, 2016

Primary Completion

July 7, 2021

Study Completion

December 1, 2021

Last Updated

June 4, 2021

Record last verified: 2021-05

Locations

CN(1)