Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens

NCT02838004 | Completed DMC

• 1 other identifier: PSM15
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

Conditions

Cataract; Presbyopia

Keywords

Refractive lens exchange (RLE) or cataract surgery

Outcome Measures

Primary Outcomes (1)

• UDVA (Uncorrected Distance Visual Acuity)

  Visual acuity mesurement

  30 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).

  4 months

Other Outcomes (10)

• Visual Acuity Evaluation

  4 months

• Visual Acuity Evaluation

  4 months

• Visual Acuity Evaluation

  4 months

Study Arms (1)

Single arm receiving Mini WELL Ready IOL

EXPERIMENTAL

IOL implantation for cataract

Device: IOL MINI WELL READY

Interventions

IOL MINI WELL READY DEVICE

IOL MINI WELL READY

Single arm receiving Mini WELL Ready IOL

Eligibility Criteria

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

You may qualify if:

• Any gender and age above 18 years.
• Refractive lens exchange (RLE) or cataract surgery.
• Healthy corneas, not treated surgically.
• Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
• Patients request to receive the IOL MINI WELL READY implant

You may not qualify if:

• Previous corneal surgery (i.e. pterygium, refractive surgery).
• Eye diseases determining a probable postoperative visual acuity \< 20/40.
• Pseudoexfoliation.
• Abnormal pupil size and position.
• Use of contact lens 30 days before the preoperative visit.
• Corneal warpage.
• Predicted postoperative corneal astigmatism higher than 1 D.

Sponsors & Collaborators

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

Study Sites (1)

Prof.Dr. Gerd U. Auffarth

Heidelberg, Germany

Location

Related Publications (11)

• 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

• 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

• 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

• Ucakhan OO, Ozkan M, Kanpolat A. Anterior chamber parameters measured by the Pentacam CES after uneventful phacoemulsification in normotensive eyes. Acta Ophthalmol. 2009 Aug;87(5):544-8. doi: 10.1111/j.1755-3768.2008.01305.x. Epub 2008 Sep 11.

  PMID: 18786130 BACKGROUND

• Savini G, Olsen T, Carbonara C, Pazzaglia S, Barboni P, Carbonelli M, Hoffer KJ. Anterior chamber depth measurement in pseudophakic eyes: a comparison of Pentacam and ultrasound. J Refract Surg. 2010 May;26(5):341-7. doi: 10.3928/1081597X-20090617-02. Epub 2010 May 19.

  PMID: 20506991 BACKGROUND

• 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 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

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• GERD U. AUFFARTH, Prof. Dr.

  RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 20, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)