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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing visual outcomes after implanting two types of intraocular lenses (IOLs) called Synthesis Plus and Synthesis Plus Toric in adults aged 50 and older undergoing cataract surgery. This study aims to determine if the distance-corrected intermediate visual acuity at 66 cm with the Synthesis Plus Toric is not worse than with the Synthesis Plus lens. The study focuses on patients with cataracts who may or may not have pre-existing astigmatism. Participants receive either the Synthesis Plus Toric IOL, designed for patients with pre-existing astigmatism, or the Synthesis Plus IOL for those with little or no astigmatism. Both lenses are implanted during bilateral cataract surgery. The study includes follow-up assessments at one month after surgery to evaluate vision and lens performance. During the study, participants will undergo various eye exams including measurements of visual acuity at different distances, refraction tests, and assessments of lens rotation and complications. Researchers also collect subjective feedback on the quality of vision. The main outcome measured is the intermediate visual acuity at 66 cm one month after surgery. The study is conducted at a single center and is sponsored by Cutting Edge SAS.
CONDITIONS
Brief 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
- Requires bilateral cataract surgery
- For Synthesis Plus Toric group: regular corneal astigmatism greater than 0.5 diopters measured by MS-39
- For Synthesis Plus group: regular corneal astigmatism less than or equal to 0.5 diopters measured by MS-39
- Expected postoperative astigmatism less than or equal to 0.75 diopters
- Corneal astigmatism less than or equal to 4 diopters
- Intraocular lens spherical equivalent power between 15 and 25 diopters
- Signed informed consent
- Willingness and ability to comply with examination procedures
You will not qualify if you...
- Potential postoperative visual acuity less than 5/10 due to degenerative eye disorders, poor retinal function, or damaged cornea
- Amblyopia with visual acuity potential less than 5/10
- Need for intraocular lens power outside 15 to 25 diopters
- Difficulty cooperating due to distance, health condition, or other reasons
- Acute or chronic diseases increasing risk or affecting results, such as diabetes with retinopathy, immunocompromised status, glaucoma
- Irregular astigmatism
- Expected postoperative astigmatism greater than 0.75 diopters
- Any ocular comorbidity
- History of ocular trauma or prior eye surgery including refractive procedures
- Capsule or zonular abnormalities affecting lens positioning
- Chronic uveitis
- Abnormal pupil conditions
- Narrow anterior chamber (depth less than or equal to 2.5 mm)
- Corneal pathologies affecting topography such as keratoconus
- Monophthalmia
- Phacodonesis
- Complicated surgery
- Inability to place intraocular lens safely
- Zonular laxity
- Postoperative endophthalmitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo implantation of either the Synthesis Plus or Synthesis Plus Toric intraocular lens as part of their cataract surgery.
1 visit (surgery day)
Duration - 1 month
Participants are monitored for visual outcomes, potential complications, and lens stability after the implantation.
Visits on day 0 (perioperatively) and at 1 month
Trial Site Locations
Total: 1 location
1
VISIS
Perpignan, France, 66000
Actively Recruiting
Research Team
L
Line Bettinelli, OD
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
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