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

SIFI

Status: Completed

Conditions: Cataract; Presbyopia

Treatments: Device: EDOF Mini WELL Ready IOL

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02740010

PSM8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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