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

N/ACompletedNCT04801992

SIFI SpA23 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cataract

Interventions

MINI WELL Ready (SIFI SpA, Italy)DEVICE

Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"

Bari, Italy

Outcomes

Primary Outcomes

Subjective Refraction

Time frame: 26 months

Binocular Defocus Curve

Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments)

Time frame: 26 months

UDVA

Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m

Time frame: 26 months

CDVA

Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m

Time frame: 26 months

UIVA at 100 cm

Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast)

Time frame: 26 months

DCIVA at 100 cm

Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast)

Time frame: 26 months

UIVA at 60 cm

Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)

Time frame: 26 months

DCIVA at 60 cm

Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)

Time frame: 26 months

UNVA

Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast)

Time frame: 26 months

Data from ClinicalTrials.gov

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Secondary Outcomes

Postoperative Complications Rate of postoperative complication

Time frame: 26 months

Subjective Posterior Capsule Opacification

Subjective assessment through slit lamp

Time frame: 20-26 months

Posterior Capsulotomy

Time frame: 26 months

Adverse Events including SSIs

Time frame: 26 months

Device Deficiencies

Descriptive assessment

Time frame: 26 months

Photic Phenomena Assessment

Using the Halo and Glare Simulator software

Time frame: 26 months