Visual Performance of Multifocal Intraocular Lenses

Cataract Clinical Trial

Official title:

Clinical Outcomes With an Extended Range of Vision Intraocular Lens

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04913792
• Other study ID #: APAC-20161013
• Status: Enrolling by invitation
• Start date: November 1, 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2021
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• IOL

Intervention

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.)

Locations

Country	Name	City	State
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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):5 — View Citation

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-201706 — View Citation

Esteve-Taboada JJ, Domínguez-Vicent A, Del Águila-Carrasco AJ, Ferrer-Blasco T, Montés-Micó 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. — View Citation

Kaymak H, Höhn 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: 10.10 — View Citation

Millán 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected distance VA(5m,66cm,40cm)	logarithmic visual acuity chart	After operation (Month 3)
Secondary	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)
Secondary	abberation and kappa angle	iTrace visual function analyzer	After operation (Month 3)
Secondary	MTF cut-of and OSI	MTF cut-of and OSI values measured by optical quality analysis system [OQAS]	After operation (Month 3)