Cataract
Conditions
Keywords
Cataract surgery, Extended Depth-of-Focus (EDOF), Intraocular Lens (IOL), Presbyiopa correction
Brief summary
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.
Detailed description
The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)
Interventions
DEVICEMINI WELL Ready (SIFI SpA, Italy)
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.
Sponsors
Opera CRO, a TIGERMED Group Company
SIFI SpA
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VR-11R | 26 months | Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties) |
| UIVA at 60 cm | 26 months | Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast) |
| DCIVA at 60 cm | 26 months | Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast) |
| UNVA | 26 months | Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast) |
| DCNVA | 26 months | Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast) |
| Contrast Sensitivity | 26 months | Binocular Contrast Sensitivity with correction for distance |
| Reading Performance | 26 months | Binocular Reading Performance with and without correction for distance |
| Subjective Refraction | 26 months | — |
| Binocular Defocus Curve | 26 months | Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments) |
| UDVA | 26 months | Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m |
| CDVA | 26 months | Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m |
| UIVA at 100 cm | 26 months | Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast) |
| DCIVA at 100 cm | 26 months | Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Deficiencies | 26 months | Descriptive assessment |
| Photic Phenomena Assessment | 26 months | Using the Halo and Glare Simulator software |
| Postoperative Complications Rate of postoperative complication | 26 months | — |
| Subjective Posterior Capsule Opacification | 20-26 months | Subjective assessment through slit lamp |
| Posterior Capsulotomy | 26 months | — |
| Adverse Events including SSIs | 26 months | — |
Countries
Italy
Outcome results
None listed