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Recruiting NCT05561478

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

— Observational Cataract Surgery IOL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantation of Synthesis Plus IOL (control device), Implantation of Synthesis Plus Toric IOL (investigational device).
Who it may be relevant to
Registry conditions: Cataract, Surgery, IOL. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • DCIVA at 66 cm [Time frame: 1 month]
Secondary outcome measures (8)
  • Monocular UDVA [Time frame: 1 month]
  • Monocular BCDVA [Time frame: 1 month]
  • Monocular UIVA [Time frame: 1 month]
  • Monocular DCIVA [Time frame: 1 month]
  • Refraction [Time frame: 1 month]
  • Potential complications [Time frame: 1 month]
  • Rotational stability [Time frame: Peroperatively, day 0, Month 1]
  • Subjective quality of vision [Time frame: 1 month]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • VISIS — Perpignan

Identifiers

NCT: NCT05561478 · 2021-A02415-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗