Clinical trial NCT04913792: Visual Performance of Multifocal Intraocular Lenses
Official title: Clinical Outcomes With an Extended Range of Vision Intraocular Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IOL
Cataract
Keywords: multifocal IOL
ocular optical quality
abberation
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uncorrected distance VA（5m，66cm，40cm）
timeFrame: After operation （Month 3）
Secondary outcomes:
measure: Questionnaire concerning halo and visual function
timeFrame: After operation （Month 3）
measure: abberation and kappa angle
timeFrame: After operation （Month 3）
measure: MTF cut-of and OSI
timeFrame: After operation （Month 3）
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: yune zhao, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
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-20170621-08.
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):582-90. doi: 10.1016/j.jcrs.2015.11.047.
citation: 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.