Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens (PSM15)

An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

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

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: IOL MINI WELL READY

Detailed Description

To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • Prof.Dr. Gerd U. Auffarth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm receiving Mini WELL Ready IOL; IOL implantation for cataract	Device: IOL MINI WELL READY; IOL MINI WELL READY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDVA (Uncorrected Distance Visual Acuity)	Visual acuity mesurement	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).	Safety assessment	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity Evaluation	Corrected Distance Visual Acuity (CDVA)	4 months
Visual Acuity Evaluation	Uncorrected Near Visual Acuity (UNVA)	4 months
Visual Acuity Evaluation	Distance-Corrected Near Visual Acuity (DCNVA)	4 months
Visual Acuity Evaluation	Corrected Near Visual Acuity (CNVA)	4 months
Visual Acuity Evaluation	Uncorrected Intermediate Visual Acuity (UIVA)	4 months
Visual Acuity Evaluation	Distance-Corrected Intermediate Visual Acuity (DCIVA)	4 months
Halos and Glare evaluation	Onset of halos Onset of glare during night vision	4 months
Contrast sensitivity	Contrast sensitivity, at 3 meters, under photopic conditions and with the correction for distance, using YANG SMART (SIFI Medtech), with sine wave gradings (''vistech")	4 months
Reading Performance	Reading Performance tested with Radner Reading Chart - Precision Vision: The test will be performed from the largest to the smallest size of letters in two sessions: Binocular, without the correction for distance, at 40 cm; Binocular, with the correction for distance, at 40 cm	4 months
Defocus Curve	Binocular defocus curves with step of 0.5 D (from +2.0 to -5.0 D) under photopic conditions.	4 months

Collaborators and Investigators

• Sponsor: SIFI SpA
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Principal Investigator: GERD U. AUFFARTH, Prof. Dr., RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Refractive lens exchange (RLE) or cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: PSM15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No