Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant

SIFI

Status: Completed

Conditions: Cataract

Treatments: Device: MINI WELL Ready (SIFI SpA, Italy)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04801992

PSM8 Sub-study

Details and patient eligibility

About

The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo & Glare Simulator.

Full description

The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:

• Any gender and age above 18 years.
• Cataract or Refractive Lens Exchange (RLE) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position.
• Symmetrical preoperative keratometric astigmatism < 1.00 D.
• Healthy corneas, not surgically treated

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.

Trial design

23 participants in 1 patient group

MINI WELL Ready (SIFI SpA, Italy)

Description:

Extended depth of focus intraocular lens implantation

Treatment:

Device: MINI WELL Ready (SIFI SpA, Italy)