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

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ClinicalTrials.gov Identifier: NCT02740010
Recruitment Status : Enrolling by invitation
First Posted : April 15, 2016
Last Update Posted : March 12, 2019
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 : 97 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
Study Start Date : March 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

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

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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


Locations
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Italy
SIFI MedTech Srl
Catania, Italy
Sponsors and Collaborators
SIFI SpA
Opera CRO, a TIGERMED Group Company
Investigators
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Study Director: Anna Scuderi, MD SIFI MedTech Srl, Catania (Italy)

Publications:
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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02740010     History of Changes
Other Study ID Numbers: PSM8
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
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