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

Recruiting

• Conditions: Cataract; Surgery; IOL

• Registration Number: NCT05561478
• Lead Sponsor: Cutting Edge SAS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2022-10-10
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DCIVA at 66 cm	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 Outcome Measures

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

Trial Locations

Locations (1)

VISIS; 🇫🇷 Perpignan, France