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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorCutting Edge SAS

About this trial

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

Qualifiers

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

Disqualifiers

Complicated surgery

Inability to place the intraocular lens safely at the location planned

Subjects with zonular laxity

Postoperative endophthalmitis

Trial design

Treatments tested in this trial

  • Implantation of Synthesis Plus IOL (control device)
  • Implantation of Synthesis Plus Toric IOL (investigational device)

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators