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

Last updated: February 10, 2025
Sponsor: Cutting Edge SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Eye Disorders/infections

Vision Loss

Treatment

Implantation of Synthesis Plus Toric IOL (investigational device)

Implantation of Synthesis Plus IOL (control device)

Clinical Study ID

NCT05561478
2021-A02415-36
  • Ages > 50
  • All Genders

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.

Eligibility Criteria

Inclusion

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 regularitydetermined by the topography) for patients implanted with SYNTHESIS PLUS TORIC orRegular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimKkeratometry and regularity determined by the topography) for patients implanted withSYNTHESIS 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 withexamination procedures

Non inclusion Criteria:

  • Patients with a potential postoperative visual acuity of less than 5/10, inparticular due to degenerative visual disorders, poor retinal function or a damagedcornea.

  • 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 studyresults (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucomaetc...)

  • 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 ofthe lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)

  • Patients with chronic uveitis

  • Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupilsthat do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mmin photopic conditions))

  • Narrow anterior chambers (ACD ≤ 2.5 mm)

  • Any corneal pathology potentially affecting the topography (eg. Keratoconus),

  • Monophthalma patients

  • Phacodonesis

Exclusion

Exclusion criteria:

  • Complicated surgery

  • Inability to place the intraocular lens safely at the location planned

  • Subjects with zonular laxity

  • Postoperative endophthalmitis

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Implantation of Synthesis Plus Toric IOL (investigational device)
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • VISIS

    Perpignan, 66000
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.