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

Not Applicable

Completed

• Conditions: Cataract; Presbyopia
• Interventions: Device: IOL MINI WELL READY

• Registration Number: NCT02838004
• Lead Sponsor: SIFI SpA

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Study Start: 2016-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm receiving Mini WELL Ready IOL	IOL MINI WELL READY	IOL implantation for cataract

Primary Outcome Measures

Name	Time	Method
UDVA (Uncorrected Distance Visual Acuity)	30 days	Visual acuity mesurement

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).	4 months	Safety assessment

Trial Locations

Locations (1)

Prof.Dr. Gerd U. Auffarth; 🇩🇪 Heidelberg, Germany