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

NCT02740010 | Completed DMC

• 1 other identifier: PSM8
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia

Keywords

extended depth of focus; cataract surgery; presbyopia correction

Outcome Measures

Primary Outcomes (1)

• Refraction; UDVA (Uncorrected Distance Visual Acuity); CDVA (Corrected Distance Visual Acuity); DCNVA (Distance Corrected Near Visual Acuity); Defocus curve; Reading speed; Halometry.

  60 days

Secondary Outcomes (1)

• Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).

  60 days

Other Outcomes (1)

• Contrast sensitivity

  60 days

Interventions

EDOF Mini WELL Ready IOL DEVICE

implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SIFI SpA: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Location

Related Publications (12)

• 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.

  PMID: 26671689 BACKGROUND

• 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.

  PMID: 26948789 BACKGROUND

• 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.

  PMID: 18090888 BACKGROUND

• 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.

  PMID: 19643497 BACKGROUND

• 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.

  PMID: 17166341 BACKGROUND

• 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.

  PMID: 13129879 BACKGROUND

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

  PMID: 10724823 BACKGROUND

• 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.

  PMID: 16931257 BACKGROUND

• 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.

  PMID: 19969208 BACKGROUND

• 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.

  PMID: 22018366 BACKGROUND

• 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.

  PMID: 24932989 BACKGROUND

• 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.

  PMID: 22553713 BACKGROUND

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 15, 2016
• Study Start: September 2, 2020
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

IT (1)