An interventional study of MINI WELL READY ® and FINE VISION® in Cataract and Presbyopia, sponsored by SIFI SpA. Terminated at 2 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by SIFI SpA · Not applicable, Interventional, and Other
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
Device: MINI WELL READY ®
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
Device: FINE VISION®
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
Defocus curve - binocular
Defocus curve assessment
Time frame: 6 months
Refraction
Ocular refraction evaluation
Time frame: 6 months
Visual Acuity Evaluation
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 6 months
Visual Acuity Evaluation
Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 6 months
Visual Acuity Evaluation
Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 6 months
Visual Acuity Evaluation
Uncorrected Near Visual Acuity (UNVA)
Time frame: 6 months
Visual Acuity Evaluation
Distance Corrected Near Visual Acuity (DCNVA)
Time frame: 6 months
Reading speed
Reading speed performance
Time frame: 6 months
Halometry
Halos evaluation
Time frame: 6 months
Contrast sensitivity
Contrast sensitivity evaluation
Time frame: 6 months
Subject satisfaction questionnaire - VF-11R
Subject satisfaction questionnaire - VF-11R "revised version": Annex A: Subject's glasses independence and light dependence Annex B: Quality of Vision (QoV) questionnaire
Time frame: 6 months
Operative Complications / Postoperative Complications / Adverse Event Assessment
Assessment of Operative Complications, Postoperative Complications, Adverse Events
Time frame: 6 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SIFI SpA