The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

NCT ID: NCT02740010

Last Updated: 2021-03-23

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-02

Study Completion Date

2020-10-28

Brief Summary

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The purpose of this observational, non-controlled, multicenter trial with a retrospective design is to evaluate the visual performance of one cohort of patients who received the EDOF MINI WELL® intraocular lenses following refractive lens exchange (RLE) or cataract surgery.

Detailed Description

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The study aims at evaluating the visual performance of the EDOF MINI WELL® in qualitative and quantitative terms of the progressive vision. The cohort of subjects includes all patients submitted in the six involved Centers. for the surgical procedure for cataract extraction or Refractive Lens Exchange (RLE) using the MINI WELL® with a pre-operative visit (from the day - 60 to day -1 before surgery) and a post-operative follow-up visit performed 30-60 days after implant.

Conditions

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Cataract Presbyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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EDOF Mini WELL Ready IOL

implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any gender and age above 18 years
* Refractive lens exchange (RLE) or cataract surgery
* Symmetrical preoperative keratometric astigmatism \< 0.75 D
* Healthy corneas, not treated surgically

Exclusion Criteria

* Previous corneal surgery (i.e. pterygium, refractive surgery)
* Eye diseases with visual acuity \< 20/32
* Pseudoexfoliation
* Abnormal pupil size and position.
* Use of contact lens 30 days before the preoperative visit.
* Corneal warpage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role collaborator

SIFI SpA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Site Status

Countries

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Italy

References

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Dominguez-Vicent A, Esteve-Taboada JJ, Del Aguila-Carrasco AJ, Ferrer-Blasco T, Montes-Mico R. In vitro optical quality comparison between the Mini WELL Ready progressive multifocal and the TECNIS Symfony. Graefes Arch Clin Exp Ophthalmol. 2016 Jul;254(7):1387-97. doi: 10.1007/s00417-015-3240-7. Epub 2015 Dec 16.

Reference Type BACKGROUND
PMID: 26671689 (View on PubMed)

Dominguez-Vicent A, Esteve-Taboada JJ, Del Aguila-Carrasco AJ, Monsalvez-Romin D, Montes-Mico R. In vitro optical quality comparison of 2 trifocal intraocular lenses and 1 progressive multifocal intraocular lens. J Cataract Refract Surg. 2016 Jan;42(1):138-47. doi: 10.1016/j.jcrs.2015.06.040.

Reference Type BACKGROUND
PMID: 26948789 (View on PubMed)

Packer M, Fine IH, Hoffman RS. Aspheric intraocular lens selection: the evolution of refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):1-4. doi: 10.1097/ICU.0b013e3282f2d791. No abstract available.

Reference Type BACKGROUND
PMID: 18090888 (View on PubMed)

Kohnen T, Klaproth OK, Buhren J. Effect of intraocular lens asphericity on quality of vision after cataract removal: an intraindividual comparison. Ophthalmology. 2009 Sep;116(9):1697-706. doi: 10.1016/j.ophtha.2009.03.052. Epub 2009 Jul 29.

Reference Type BACKGROUND
PMID: 19643497 (View on PubMed)

Lehmann R, Waycaster C, Hileman K. A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039.

Reference Type BACKGROUND
PMID: 17166341 (View on PubMed)

Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. doi: 10.1016/S0161-6420(03)00722-X.

Reference Type BACKGROUND
PMID: 13129879 (View on PubMed)

Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.

Reference Type BACKGROUND
PMID: 10724823 (View on PubMed)

Blaylock JF, Si Z, Vickers C. Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. J Cataract Refract Surg. 2006 Sep;32(9):1464-73. doi: 10.1016/j.jcrs.2006.04.011.

Reference Type BACKGROUND
PMID: 16931257 (View on PubMed)

Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study. J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041.

Reference Type BACKGROUND
PMID: 19969208 (View on PubMed)

Munoz G, Albarran-Diego C, Ferrer-Blasco T, Sakla HF, Garcia-Lazaro S. Visual function after bilateral implantation of a new zonal refractive aspheric multifocal intraocular lens. J Cataract Refract Surg. 2011 Nov;37(11):2043-52. doi: 10.1016/j.jcrs.2011.05.045.

Reference Type BACKGROUND
PMID: 22018366 (View on PubMed)

Pepose JS, Qazi MA, Chu R, Stahl J. A prospective randomized clinical evaluation of 3 presbyopia-correcting intraocular lenses after cataract extraction. Am J Ophthalmol. 2014 Sep;158(3):436-46.e1. doi: 10.1016/j.ajo.2014.06.003. Epub 2014 Jun 14.

Reference Type BACKGROUND
PMID: 24932989 (View on PubMed)

Jiang T, Jiang J, Zhou Y, Zhao GQ, Li H, Zhao SY. Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. Int J Ophthalmol. 2011;4(5):513-8. doi: 10.3980/j.issn.2222-3959.2011.05.11. Epub 2011 Oct 18.

Reference Type BACKGROUND
PMID: 22553713 (View on PubMed)

Other Identifiers

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PSM8

Identifier Type: -

Identifier Source: org_study_id

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