Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens

SIFI SpA77 enrolled

Overview

This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cataract Presbyopia

Interventions

IOL MINI WELL READYDEVICE

IOL MINI WELL READY

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any gender and age above 18 years. * Refractive lens exchange (RLE) or cataract surgery. * Healthy corneas, not treated surgically. * Patients willing to have surgery in both eyes in a short period of time (within 2 weeks). * Patients request to receive the IOL MINI WELL READY implant Exclusion Criteria: * Previous corneal surgery (i.e. pterygium, refractive surgery). * Eye diseases determining a probable postoperative visual acuity \< 20/40. * Pseudoexfoliation. * Abnormal pupil size and position. * Use of contact lens 30 days before the preoperative visit. * Corneal warpage. * Predicted postoperative corneal astigmatism higher than 1 D.

Locations (1)

Prof.Dr. Gerd U. Auffarth

Heidelberg, Germany

Outcomes

Primary Outcomes

UDVA (Uncorrected Distance Visual Acuity)

Visual acuity mesurement

Time frame: 30 days

Secondary Outcomes

Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).

Safety assessment

Time frame: 4 months

Data from ClinicalTrials.gov

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