NCT05561478

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 11, 2025

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

September 27, 2022

Last Update Submit

February 10, 2025

Conditions

CataractSurgeryIOL

Outcome Measures

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

    1 month

Secondary Outcomes (8)

  • Monocular UDVA

    1 month

  • Monocular BCDVA

    1 month

  • Monocular UIVA

    1 month

  • Monocular DCIVA

    1 month

  • Refraction

    1 month

  • +3 more secondary outcomes

Study Arms (2)

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

Implantation of Synthesis Plus IOL (control device)DEVICE

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

Control device (Synthesis Plus)
Implantation of Synthesis Plus Toric IOL (investigational device)DEVICE

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

Test device (Synthesis Plus Toric)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient requiring bilateral cataract surgery

You may qualify if:

  • 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
  • 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.
  • +9 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VISIS

Perpignan, 66000, France

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Boris Dethinne, MD

    Visis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Line Bettinelli, OD

CONTACT

0619530701line.bettinelli@cutting-edge.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

October 10, 2022

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

February 11, 2025

Record last verified: 2024-09

Locations

FR(1)