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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 : Completed
First Posted : April 15, 2016
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
SIFI MedTech Srl

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 multifocal intraocular lenses (MIOL) MINI WELL® following refractive lens exchange (RLE) or cataract surgery. Primary outcome were: Uncorrected Distance Visual Acuity, Best Corrected Visual Acuity, Best Corrected Near Visual Acuity, onset of halos and glare (during night vision). It was also evaluated: Distance-Corrected Contrast sensitivity without glare, reading speed with the best correction for distance, and Defocus Curve under photopic conditions. ADE/SADE/USADE and AE/SAE were secondary outcomes.

Condition or disease Intervention/treatment
Vision Disorders Device: MIOL MINI WELL

Detailed Description:
In order to obtain a presbyopia-correcting IOL with a continuous range of vision, SIFI MedTech (Catania, Italy) recently developed Mini WELL®, a preloaded progressive multifocal aspheric IOL, which optical design increases the depth of focus to generate continuum foci. The in vitro optical quality of this lens has been assessed showing larger defocus tolerance at near distance vision (in comparison with diffractive lens) and a better optical quality at far vision with 4.5 mm aperture against both diffractive, and trifocal lens. Mini WELL® has been granted a CE-mark for use only in March 2014, but it has quickly gained pleasing evaluations in ophthalmology congress. On June 2015, verified that no publication on Mini WELL® clinical performance was yet available, four Italian Investigators have decided to collaborate in a retrospectively study. The collected sample is fully representative of Italian population, considering the total number of MINI WELL® delivered in Italy (150 lens on August 2015) and the range of involved sides (University Department, Ophthalmology Research Institute, Public Hospital and Private Clinics). The primary objective of the trial is to evaluate retrospectively the visual performance of the MINI WELL® in qualitative and quantitative terms of the progressive vision. The collected variables are: Uncorrected distance Visual Acuity (UCVA), Best Corrected Visual Acuity (BCVA), Best Corrected Near Visual Acuity (BCNVA), onset of halos, and onset of glare during night vision. In addition, are also evaluated: Monocular Distance-Corrected Contrast sensitivity without glare, Monocular and binocular reading speed with the best correction for distance and Monocular Defocus Curve under photopic conditions. The secondary outcomes are: ADE/SADE/USADE and AE/SAE. The cohort of subjects includes all patients submitted in the five involved Centers for the surgical procedure for cataract extraction or Refractive Lens Exchange (RLE) using the MINI WELL® with a pre-operative visit (from day - 30 to day -2 before surgery) and a post-operative follow up visit performed 30 days after implant (with a window of - 14 and + 28 days). The period of observation is from March 1st, 2014 to March, 31st, 2016, while the Data Collection period is from April, 30th, 2016 to July, 31st, 2016

Study Type : Observational
Actual 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
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MIOL MINI WELL
    MIOL implant


Primary Outcome Measures :
  1. Uncorrected Distance Visual Acuity (UCVA), Best Corrected Visual Acuity (BCVA), Best Corrected Near Visual Acuity (BCNVA); onset of halos; onset of glare during night vision. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Serious Adverse Device Effects / Serious Adverse Events /Adverse Device Effects/ Adverse Events [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Monocular distance-corrected contrast sensitivity without glare; monocular and binocular reading speed with the best correction for distance; monocular defocus curve under photopic conditions. [ Time Frame: 30 days ]


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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
Italy
SIFI MedTech Srl
Catania, Italy
Romania
Opera Contract Research Organization Srl
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
SIFI MedTech Srl
Opera Contract Research Organization SRL
Investigators
Study Director: Anna Scuderi, MD SIFI MedTech Srl, Catania (Italy)

Publications:
Responsible Party: SIFI MedTech Srl
ClinicalTrials.gov Identifier: NCT02740010     History of Changes
Other Study ID Numbers: PSM8
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by SIFI MedTech Srl:
MIOL
extended depth of focus
cataract
visual acuity
halos

Additional relevant MeSH terms:
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms