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Status unknownNCT05561478DETPLUSTUpdated Feb 11, 2025

Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

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

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
72
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cataract
  • Surgery
  • IOL

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03

In context

Cataract

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Inclusion criteria

  • Patient older than 50 years old
  • Patient requiring bilateral cataract surgery
  • Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
  • Expected postoperative astigmatism ≤ 0.75D diopter
  • Corneal astigmatism ≤4D
  • IOL spherical equivalent power requested between 15D and 25D
  • Signed informed consent
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Non inclusion Criteria:

  • Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.
  • Amblyopia with a visual acuity potential of less than 5/10
  • IOL power needed outside the spherical equivalent diopter range: 15 to 25D
  • Difficulty for cooperation (distance from their home, general health condition)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
  • Irregular astigmatism
  • Subject with postoperative astigmatism, expected > 0.75 D.
  • Any ocular comorbidity
  • History of ocular trauma or prior ocular surgery including refractive procedures
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
  • Patients with chronic uveitis
  • Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or \<2.5 mm in photopic conditions))
  • Narrow anterior chambers (ACD ≤ 2.5 mm)
  • Any corneal pathology potentially affecting the topography (eg. Keratoconus),
  • Monophthalma patients
  • Phacodonesis

Exclusion criteria

Exclusion criteria:

  • Complicated surgery
  • Inability to place the intraocular lens safely at the location planned
  • Subjects with zonular laxity
  • Postoperative endophthalmitis
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
72 participants (estimated)
Patient registry
No

Groups and cohorts

  • Test device (Synthesis Plus Toric)

    Requiring bilateral cataract surgery with pre-existing astigmatism

    Device: Implantation of Synthesis Plus Toric IOL (investigational device)

  • Control device (Synthesis Plus)

    Requiring bilateral cataract surgery

    Device: Implantation of Synthesis Plus IOL (control device)

Interventions

  • DeviceImplantation of Synthesis Plus IOL (control device)

    Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.

  • DeviceImplantation of Synthesis Plus Toric IOL (investigational device)

    Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Monocular UDVA

    distance

    Time frame: 1 month

  2. Monocular BCDVA

    distance

    Time frame: 1 month

  3. Monocular UIVA

    66 cm

    Time frame: 1 month

  4. Monocular DCIVA

    66 cm

    Time frame: 1 month

  5. Refraction

    subjective

    Time frame: 1 month

  6. Potential complications

    postoperative

    Time frame: 1 month

  7. Rotational stability

    in degrees

    Time frame: Peroperatively, day 0, Month 1

  8. Subjective quality of vision

    PROM

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • VISIS
    Perpignan, 66000, France
    • Boris DETHINNE, MD · Contact
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Sep 27, 2022
First posted
Sep 30, 2022
StartActual
Oct 10, 2022
Primary completionEst.
Aug 2025
CompletionEst.
Oct 2025
Last update
Feb 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05561478
Lead sponsor
Cutting Edge SAS
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Oct 10, 2022
Primary completion
Aug 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Feb 11, 2025

Study contacts

Line Bettinelli, OD
Contact
line.bettinelli@cutting-edge.fr
0619530701
Boris Dethinne, MD
principal investigator · Visis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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