Comparing visual outcomes of two types of intraocular lenses for cataract surgery
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
This study is testing whether a special type of lens for cataract surgery works just as well as a standard lens for people over 50 with certain vision needs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Cutting Edge SAS Industry-sponsored |
| Locations | 1 site (Perpignan) |
| Trial ID | NCT05561478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the non-inferiority of distance-corrected intermediate visual acuity at 66 cm between two types of intraocular lenses (IOLs): the Synthesis Plus Toric and the Synthesis Plus. It involves patients over 50 years old who require bilateral cataract surgery and have specific corneal astigmatism measurements. The study will compare the visual outcomes after the implantation of these two IOLs to determine if the Toric lens performs similarly to the standard lens. The research is being conducted at a single center in Perpignan.
Who should consider this trial
Good fit: Ideal candidates are patients over 50 years old requiring bilateral cataract surgery with specific corneal astigmatism measurements.
Not a fit: Patients with degenerative visual disorders or those who are unlikely to achieve a postoperative visual acuity of at least 5/10 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of the Synthesis Plus Toric IOL for patients with astigmatism undergoing cataract surgery.
How similar studies have performed: Previous studies have shown promising results with similar intraocular lens comparisons, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Perpignan
- Visis — Perpignan, France (Recruiting)
Study contacts
- Principal investigator: Boris Dethinne, MD — Visis
- Study coordinator: Line Bettinelli, OD
- Email: line.bettinelli@cutting-edge.fr
- Phone: 0619530701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.