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

NCT05561478 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2025-02-11

No results posted yet for this 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.

Conditions

  • Cataract
  • Surgery
  • IOL

Interventions

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.

DEVICE

Implantation 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.

Sponsors & Collaborators

  • Cutting Edge SAS

    lead INDUSTRY

Principal Investigators

  • Boris Dethinne, MD · Visis

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561478 on ClinicalTrials.gov