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

Primary Purpose

Cataract, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
IOL MINI WELL READY
Sponsored by
SIFI SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract focused on measuring Refractive lens exchange (RLE) or cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prof.Dr. Gerd U. Auffarth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm receiving Mini WELL Ready IOL

Arm Description

IOL implantation for cataract

Outcomes

Primary Outcome Measures

UDVA (Uncorrected Distance Visual Acuity)
Visual acuity mesurement

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2016
Last Updated
January 13, 2020
Sponsor
SIFI SpA
Collaborators
Opera CRO, a TIGERMED Group Company
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1. Study Identification

Unique Protocol Identification Number
NCT02838004
Brief Title
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
Acronym
PSM15
Official Title
An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SIFI SpA
Collaborators
Opera CRO, a TIGERMED Group Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia
Keywords
Refractive lens exchange (RLE) or cataract surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm receiving Mini WELL Ready IOL
Arm Type
Experimental
Arm Description
IOL implantation for cataract
Intervention Type
Device
Intervention Name(s)
IOL MINI WELL READY
Intervention Description
IOL MINI WELL READY
Primary Outcome Measure Information:
Title
UDVA (Uncorrected Distance Visual Acuity)
Description
Visual acuity mesurement
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).
Description
Safety assessment
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Visual Acuity Evaluation
Description
Corrected Distance Visual Acuity (CDVA)
Time Frame
4 months
Title
Visual Acuity Evaluation
Description
Uncorrected Near Visual Acuity (UNVA)
Time Frame
4 months
Title
Visual Acuity Evaluation
Description
Distance-Corrected Near Visual Acuity (DCNVA)
Time Frame
4 months
Title
Visual Acuity Evaluation
Description
Corrected Near Visual Acuity (CNVA)
Time Frame
4 months
Title
Visual Acuity Evaluation
Description
Uncorrected Intermediate Visual Acuity (UIVA)
Time Frame
4 months
Title
Visual Acuity Evaluation
Description
Distance-Corrected Intermediate Visual Acuity (DCIVA)
Time Frame
4 months
Title
Halos and Glare evaluation
Description
Onset of halos Onset of glare during night vision
Time Frame
4 months
Title
Contrast sensitivity
Description
Contrast sensitivity, at 3 meters, under photopic conditions and with the correction for distance, using YANG SMART (SIFI Medtech), with sine wave gradings (''vistech")
Time Frame
4 months
Title
Reading Performance
Description
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
Time Frame
4 months
Title
Defocus Curve
Description
Binocular defocus curves with step of 0.5 D (from +2.0 to -5.0 D) under photopic conditions.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GERD U. AUFFARTH, Prof. Dr.
Organizational Affiliation
RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof.Dr. Gerd U. Auffarth
City
Heidelberg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22553713
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.
Results Reference
background
PubMed Identifier
18090888
Citation
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.
Results Reference
background
PubMed Identifier
19643497
Citation
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.
Results Reference
background
PubMed Identifier
17166341
Citation
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.
Results Reference
background
PubMed Identifier
13129879
Citation
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.
Results Reference
background
PubMed Identifier
10724823
Citation
Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.
Results Reference
background
PubMed Identifier
22018366
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.
Results Reference
background
PubMed Identifier
18786130
Citation
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.
Results Reference
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PubMed Identifier
20506991
Citation
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.
Results Reference
background
PubMed Identifier
27113882
Citation
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.
Results Reference
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PubMed Identifier
19969208
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.
Results Reference
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Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens

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