Clinical Outcomes With an Extended Range of Vision Intraocular Lens
| Registry | NCT04913792 |
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| Status | Unknown |
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| Study type | Observational |
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| Enrollment | 30 (Estimated) |
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| Sponsor | Wenzhou Medical University (Other) |
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| Conditions | IOL, Cataract |
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| Interventions | ZXR00 (Device) |
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| Dates | start 2016-11-01, primary completion 2021-07-07 (estimated), completion 2021-12-01 (estimated), first posted 2021-06-04, last updated 2021-06-04 |
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| Locations | 1 site in China |
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Related Papers Related Patents Related Grants Related Experts
All trials for IOL All trials for Cataract All trials of ZXR00
-Summary
To evaluate the clinical outcomes with an extended range of vision (ERV) IOL based on achromatic diffractive technology.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| ZXR00 | | Device: ZXR00 | The ZXR00 group included 30 patients bilaterally implanted with the Tecnis Symfony IOL (Abbott Medical Optics, Inc.) |
- ZXR00 (Device): This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)
+Outcome measures
Primary outcomes
- Uncorrected distance VA（5m，66cm，40cm） [After operation （Month 3）]: logarithmic visual acuity chart
Secondary outcomes
- Questionnaire concerning halo and visual function [After operation （Month 3）]: 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).
- abberation and kappa angle [After operation （Month 3）]: iTrace visual function analyzer
- MTF cut-of and OSI [After operation （Month 3）]: MTF cut-of and OSI values measured by optical quality analysis system \[OQAS\]
+Eligibility
Sex: All, ages: 20 Years to 85 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Ophthalmology and Optometry Hospital | Wenzhou, Zhejiang | China | |
+Publications
- Results publication: 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 28966865
- Results publication: 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 27385257
- Results publication: 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 26469074
- Results publication: 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 28991333
- Results publication: 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 27113882
- Results publication: 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 26796451
+Investigators
- yune zhao, MD, Study chair, Wenzhou Medical University