Visual Performance of Multifocal Intraocular Lenses

NCT ID: NCT04913792

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2021-12-01

Brief Summary

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

Detailed Description

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This was a prospective comparative study including 60 eyes undergoing cataract surgery with implantation of the ERV Tecnis Symfony IOL (Abbott Medical Optics, Inc.) (ERV group: 60 eyes of 30 patients). Visual, refractive, contrast sensitivity, defocus curve, ocular optical quality (Optical Quality Analysis System; iTrace), and visual function questionair(NEI-VFQ 25) outcomes were evaluated during a 3-month follow-up.

Conditions

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IOL Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ZXR00

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

ZXR00

Intervention Type DEVICE

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

Interventions

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ZXR00

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yune zhao, MD

Role: STUDY_CHAIR

Wenzhou Medical University

Locations

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Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 28966865 (View on PubMed)

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.

Reference Type RESULT
PMID: 27385257 (View on PubMed)

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.

Reference Type RESULT
PMID: 26469074 (View on PubMed)

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.

Reference Type RESULT
PMID: 28991333 (View on PubMed)

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.

Reference Type RESULT
PMID: 27113882 (View on PubMed)

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.

Reference Type RESULT
PMID: 26796451 (View on PubMed)

Other Identifiers

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APAC-20161013

Identifier Type: -

Identifier Source: org_study_id

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