CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
MINI WELL Ready (SIFI SpA, Italy)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04801992
NCT04801992N/ACompleted
CompareCT.gov

Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant

SIFI SpA·observational·Posted Mar 17, 2021·Updated Mar 22, 2021

In Brief

An observational study evaluating MINI WELL Ready (SIFI SpA, Italy) for Cataract. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesItaly
CollaboratorsOpera CRO, a TIGERMED Group Company

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 17, 2021
Enrollment StartOct 26, 2020
Primary CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 23 daysPosted 5.3 years ago

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.