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

March 22, 2021 updated by: SIFI SpA

Retrospective Observational Trial on the Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergone cataract or RLE surgery with the IOL MINI WELL and having a post-operative follow up visit (30-60 days) in the period from March, 1st 2014 to March,31st 2016.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
60 days

Other Outcome Measures

Outcome Measure
Time Frame
Contrast sensitivity
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SIFI SpA

Collaborators

Opera CRO, a TIGERMED Group Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

October 28, 2020

Study Completion (Actual)

October 28, 2020

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSM8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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