Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric (DETPLUST)

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Surgery; IOL
• Intervention / Treatment: Device: Implantation of Synthesis Plus Toric IOL (investigational device); Device: Implantation of Synthesis Plus IOL (control device)

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Line Bettinelli, OD; Phone Number: 0619530701; Email: line.bettinelli@cutting-edge.fr

Study Locations

• France
  • Perpignan, France, 66000
    • Recruiting
    • VISIS
    • Contact: Boris DETHINNE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient requiring bilateral cataract surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test device (Synthesis Plus Toric); Requiring bilateral cataract surgery with pre-existing astigmatism	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.
Control device (Synthesis Plus); Requiring bilateral cataract surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCIVA at 66 cm	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular UDVA	distance	1 month
Monocular BCDVA	distance	1 month
Monocular UIVA	66 cm	1 month
Monocular DCIVA	66 cm	1 month
Refraction	subjective	1 month
Potential complications	postoperative	1 month
Rotational stability	in degrees	Peroperatively, day 0, Month 1
Subjective quality of vision	PROM	1 month

Collaborators and Investigators

• Sponsor: Cutting Edge SAS
• Investigators: Principal Investigator: Boris Dethinne, MD, VISIS

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2021-A02415-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No