An observational study in Cataract, Surgery and IOL, sponsored by Cutting Edge SAS. Status unknown at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Cutting Edge SAS · Observational
Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 72 is below the median of 82 across 491 observational studies indexed under Cataract.
Browse Cataract studies →Cutting Edge SAS is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient requiring bilateral cataract surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non inclusion Criteria:
Exclusion criteria:
Requiring bilateral cataract surgery with pre-existing astigmatism
Device: Implantation of Synthesis Plus Toric IOL (investigational device)
Requiring bilateral cataract surgery
Device: Implantation of Synthesis Plus IOL (control device)
Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.
Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.
DCIVA at 66 cm
The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS
Time frame: 1 month
Monocular UDVA
distance
Time frame: 1 month
Monocular BCDVA
distance
Time frame: 1 month
Monocular UIVA
66 cm
Time frame: 1 month
Monocular DCIVA
66 cm
Time frame: 1 month
Refraction
subjective
Time frame: 1 month
Potential complications
postoperative
Time frame: 1 month
Rotational stability
in degrees
Time frame: Peroperatively, day 0, Month 1
Subjective quality of vision
PROM
Time frame: 1 month
Started Oct 2022 (actual). Primary completion is estimated for Aug 2025, 34 months after the start.
Of 63 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 34 months is above that.
Counting every sponsor, half of 245 studies reached it within 18 months; a quarter within 9 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. 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.
Cutting Edge SAS