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OpenTrials
Completed

NCT Number: NCT02740010

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDOF Mini WELL Ready IOL

Device

implant

Primary outcomes

  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 outcomes

  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 outcomes

  1. Contrast sensitivity

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Collaborators

  • Opera CRO, a TIGERMED Group Company

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2016
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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