Status:
UNKNOWN
Assessment of Vivity With French Clinical Data Related to the Toric Model Study
Lead Sponsor:
Versailles Hospital
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Brief Summary
Presbyopia-correcting implant (PC-IOL): AcrySof IQ Vivity (Alcon) has been evaluated in 2 large pivotal trials (US and OUS trials). These tests showed that this PC-IOL restored intermediate visual acu...
Eligibility Criteria
Inclusion
- Patient presenting for a request for cataract surgery in current practice: phacoemulsification followed by classic implantation of an IOL with small incision size (\< 2.2mm)
- Calculated power of IOL is between 10.0 and 30.0 diopters (D) in 0.5D steps to target emmetropia (0.0 +/- 0.5D)
- Patients with corneal astigmatism \> 0.5D and who can receive an implant with a toricity between T2 and T6, i.e. with astigmatism between +0.5D and +2.5D.
- If both eyes have astigmatism, the eye under study will be the right eye
- Patient having been informed and not objecting to their participation.
Exclusion
- Pregnancy or breastfeeding while conducting the study
- Person under the age of 18
- History of pathologies of the anterior segment of the eye (cornea, anterior chamber, sulcus) or posterior segment of the eye (uvea, vitreous, retina) including retinal vascular occlusions, retinal detachment, peripheral retinal laser photocoagulation, AMD and glaucoma
- Any inflammation of the anterior or posterior segment, whatever its etiology or history of disease, which may lead to an inflammatory reaction
- Clinically significant corneal pathology (epithelial, stromal, or endothelial that could affect visual outcome)
- Clinically significant severe dry eye disease that may affect visual calculations and measurements
- History of refractive surgery
- Amblyopia or monofixation syndrome
- Patient at risk of zonular rupture during the phacoemulsification procedure and may affect the centering or tilt of the implant postoperatively.
- Irregular astigmatism (corneal topography)
- Any other planned eye surgery
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05416177
Start Date
September 1 2022
End Date
July 1 2023
Last Update
August 25 2022
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