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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02740010

Enrollment

100

Registered

2016-04-15

Start date

2020-09-02

Completion date

2020-10-28

Last updated

2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Presbyopia

Keywords

extended depth of focus, cataract surgery, presbyopia correction

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.

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.

Interventions

DEVICEEDOF Mini WELL Ready IOL

implant

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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.	60 days

Secondary

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).	60 days

Other

Measure	Time frame
Contrast sensitivity	60 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026