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

Completed

• Conditions: Presbyopia; Cataract

• Registration Number: NCT02740010
• Lead Sponsor: SIFI SpA

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.

Study Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Study Start: 2020-09-02
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).	60 days

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, Italy