Clinical trial NCT05561478: Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
Official title: Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Surgery
IOL
Lead sponsor: Cutting Edge SAS
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient requiring bilateral cataract surgery

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.


Eligibility 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

Primary outcomes:
measure: DCIVA at 66 cm
timeFrame: 1 month
Secondary outcomes:
measure: Monocular UDVA
timeFrame: 1 month
measure: Monocular BCDVA
timeFrame: 1 month
measure: Monocular UIVA
timeFrame: 1 month
measure: Monocular DCIVA
timeFrame: 1 month
measure: Refraction
timeFrame: 1 month
measure: Potential complications
timeFrame: 1 month
measure: Rotational stability
timeFrame: Peroperatively, day 0, Month 1
measure: Subjective quality of vision
timeFrame: 1 month
Other outcomes:
Locations:
city: Perpignan
country: France
facility: VISIS
Study officials:
affiliation: Visis
name: Boris Dethinne, MD
role: PRINCIPAL_INVESTIGATOR
References: