Trials / Completed
CompletedNCT04801992
Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant
Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 23 (actual)
- Sponsor
- SIFI SpA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MINI 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. |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2020-11-19
- Completion
- 2020-11-19
- First posted
- 2021-03-17
- Last updated
- 2021-03-22
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04801992. Inclusion in this directory is not an endorsement.