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

Sponsor
SIFI SpA (Industry)
Overall Status
Completed
CT.gov ID
NCT02740010
Collaborator
Opera CRO, a TIGERMED Group Company (Other)
100
Enrollment
1
Location
1.8
Actual Duration (Months)
54.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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
Actual Study Start Date :
Sep 2, 2020
Actual Primary Completion Date :
Oct 28, 2020
Actual Study Completion Date :
Oct 28, 2020

Outcome Measures

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. [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). [60 days]

Other Outcome Measures

  1. Contrast sensitivity [60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy

Sponsors and Collaborators

  • SIFI SpA
  • Opera CRO, a TIGERMED Group Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
SIFI SpA
ClinicalTrials.gov Identifier:
NCT02740010
Other Study ID Numbers:
  • PSM8
First Posted:
Apr 15, 2016
Last Update Posted:
Mar 23, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by SIFI SpA
extended depth of focus
cataract surgery
presbyopia correction
Additional relevant MeSH terms:
Cataract
Presbyopia

Study Results

No Results Posted as of Mar 23, 2021