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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02740010
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Opera CRO, a TIGERMED Group Company
Information provided by (Responsible Party):
SIFI SpA

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.

Condition or disease Intervention/treatment
Cataract Presbyopia Device: EDOF Mini WELL Ready IOL

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. The period of observation is from March 2014 to March 2016, while the expected Data Collection period is from April 2016 to April 2019.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Observational Trial on the Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract


Intervention Details:
  • Device: EDOF Mini WELL Ready IOL
    implant


Primary Outcome Measures :
  1. Refraction; UDVA (Uncorrected Distance Visual Acuity); CDVA (Corrected Distance Visual Acuity); DCNVA (Distance Corrected Near Visual Acuity); Defocus curve; Reading speed; Halometry. [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE). [ Time Frame: 60 days ]

Other Outcome Measures:
  1. Contrast sensitivity [ Time Frame: 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients submitted in the involved Centers for surgery for cataract or REL using the IOL MINI WELL and a post-operative follow up visit in the period from March, 1st 2014 to March,31st 2016 and found eligible for inclusion in the study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740010


Contacts
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Contact: Rosu Serban, MD 040722313224 serban.rosu@operacro.com
Contact: Barattini Dionisio, MD 0393355437574 barattini@operacro.com

Locations
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Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Recruiting
Bari, Italy
Contact: Pr. Giovanni Alessio, MD         
Principal Investigator: Giovanni Alessio, MD - Bari         
Principal Investigator: Giacomo Savini, MD - Rome         
Principal Investigator: Scipione Rossi, MD - Rome         
Principal Investigator: Claudio Carbonara, MD - Rome         
Sponsors and Collaborators
SIFI SpA
Opera CRO, a TIGERMED Group Company
Investigators
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Study Director: Gianluca Stivale, Pharm D SIFI SpA
Publications:

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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02740010    
Other Study ID Numbers: PSM8
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by SIFI SpA:
MIOL
extended depth of focus
cataract
visual acuity
halos
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors