Clinical trial NCT02740010: The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Official title: Retrospective Observational Trial on the Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia
Keywords: extended depth of focus
cataract surgery
presbyopia correction
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2016-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergone cataract or RLE surgery with the IOL MINI WELL and having a post-operative follow up visit (30-60 days) in the period from March, 1st 2014 to March,31st 2016.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Refraction; UDVA (Uncorrected Distance Visual Acuity); CDVA (Corrected Distance Visual Acuity); DCNVA (Distance Corrected Near Visual Acuity); Defocus curve; Reading speed; Halometry.
timeFrame: 60 days
Secondary outcomes:
measure: Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).
timeFrame: 60 days
Other outcomes:
measure: Contrast sensitivity
timeFrame: 60 days
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Study officials:
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.