Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens (PSM15)

SIFI

Status: Completed

Conditions: Cataract; Presbyopia

Treatments: Device: IOL MINI WELL READY

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02838004

PSM15

Details and patient eligibility

About

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

Full 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

Enrollment: 77 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.
• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Single arm receiving Mini WELL Ready IOL

Experimental group

Description:

IOL implantation for cataract

Treatment:

Device: IOL MINI WELL READY