Actively Recruiting
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
Led by Cutting Edge SAS · Updated on 2025-02-11
72
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 50 years old
- Patient requiring bilateral cataract surgery
- Regular corneal astigmatism greater than 0.5 diopters for those implanted with SYNTHESIS PLUS TORIC or regular corneal astigmatism 0.5 diopters or less for those implanted with SYNTHESIS PLUS
- Expected postoperative astigmatism less than or equal to 0.75 diopters
- Corneal astigmatism less than or equal to 4 diopters
- IOL spherical equivalent power between 15 and 25 diopters
- Signed informed consent
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
You will not qualify if you...
- Potential postoperative visual acuity less than 5/10 due to degenerative disorders, poor retinal function, or damaged cornea
- Amblyopia with visual acuity potential less than 5/10
- IOL power needed outside 15 to 25 diopters
- Difficulty cooperating due to distance, general health, or other reasons
- Acute or chronic diseases increasing risk or confounding results (e.g., diabetes with retinopathy, immunocompromised, glaucoma)
- Irregular astigmatism
- Postoperative astigmatism expected greater than 0.75 diopters
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities affecting lens position (e.g., pseudoexfoliation syndrome, chronic uveitis, Marfan's syndrome)
- Chronic uveitis
- Abnormal pupil conditions (non-reactive, tonic, abnormal shape, or abnormal dilation)
- Narrow anterior chamber depth (less than or equal to 2.5 mm)
- Corneal pathologies affecting topography (e.g., keratoconus)
- Monophthalmos
- Phacodonesis
- Complicated surgery
- Inability to safely place the intraocular lens as planned
- Zonular laxity
- Postoperative endophthalmitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VISIS
Perpignan, France, 66000
Actively Recruiting
Research Team
L
Line Bettinelli, OD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here