Visual Performance of Multifocal Intraocular Lenses

Clinical Outcomes With an Extended Range of Vision Intraocular Lens

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract; IOL
• Intervention / Treatment: Device: ZXR00

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Ophthalmology and Optometry Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ZXR00; The ZXR00 group included 30 patients bilaterally implanted with the Tecnis Symfony IOL (Abbott Medical Optics, Inc.)	Device: ZXR00; This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected distance VA（5m，66cm，40cm）	logarithmic visual acuity chart	After operation （Month 3）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire concerning halo and visual function	NEI-VFQ 25 patient questionnaire score. The questionnaire consisted of 3 parts. The first part assessed patients' satisfaction with their overall vision during the day, or at night. The score ranged from 1 to 5 (1 = not at all; 2 = a little bit; 3 = moderately; 4 = quite a bit; 5 = extremely). In part 2, patients were asked to rate the extent to which they have difficulties with their overall vision during the day or at night. The score ranged from 1 to 5 (1 = none of the time; 2 = some of the time; 3 = half of the time; 4 = most of the time; 5 = all of the time). In part 3, patients were asked to rate their overall vision and their vision at near, intermediate, and distance on a scale ranging from 0 to 10 (0 = worst; 10 = best).	After operation （Month 3）
abberation and kappa angle	iTrace visual function analyzer	After operation （Month 3）
MTF cut-of and OSI	MTF cut-of and OSI values measured by optical quality analysis system [OQAS]	After operation （Month 3）

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Study Chair: yune zhao, MD, Wenzhou Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): July 7, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 30, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: multifocal IOL; ocular optical quality; abberation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: APAC-20161013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No