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NCT Number: NCT05561478

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VISIS

Perpignan, 66000, France

Location status: Recruiting

Location contact

Boris DETHINNE, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. DCIVA at 66 cm

    Time frame: 1 month

    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

Secondary outcomes

  1. Monocular UDVA

    Time frame: 1 month

    distance

  2. Monocular BCDVA

    Time frame: 1 month

    distance

  3. Monocular UIVA

    Time frame: 1 month

    66 cm

  4. Monocular DCIVA

    Time frame: 1 month

    66 cm

  5. Refraction

    Time frame: 1 month

    subjective

  6. Potential complications

    Time frame: 1 month

    postoperative

  7. Rotational stability

    Time frame: Peroperatively, day 0, Month 1

    in degrees

  8. Subjective quality of vision

    Time frame: 1 month

    PROM

Study contacts

Contact information is provided by the study sponsor or research team.

Line Bettinelli, OD

CONTACT

[email protected]

0619530701

Sponsors and collaborators

Lead sponsor

Cutting Edge SAS

Industry

Registry information

Acronym: DETPLUST

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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