Cataract
Conditions
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 acuity (IVA) and near visual acuity (NV A) superior to that of the reference monofocal AcrySof implant. In these tests, it was demonstrated that distance visual acuity (DVA) was non-inferior. However, the intermediate visual acuity for this implant in its toric version has not been evaluated.
Interventions
None listed
Sponsors
Versailles Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance corrected intermediate monocular visual acuity | month 3 | Intermediate monocular visual acuity (at 66 cm) corrected for distance vision (DCIVA) for the eye under study in photopic condition (normal lighting) 3 months after implantation of the 2nd eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| residual astigmatism | months 1 and 3 | measure of total residual astigmatism including corneal and internal astigmatism in dioptries |
| monocular distance visual acuity | months 1 and 3 | Corrected (BCDVA) and uncorrected monocular distance visual acuity (UCDVA) for the study eye (at 4 m) |
| monocular near visual acuity | months 1 and 3 | Corrected (DCNVA) and uncorrected monocular (UCNVA) near visual acuity for the study eye (at 40 cm) |
| monocular uncorrected intermediate visual acuity | months 1 and 3 | Uncorrected intermediate visual acuity monocular (UCIVA) for the eye under study (at 66 cm) |
| rotational stability | month 3 | Rotational stability of the IOL in the eye under study expressed in degree of rotation at 3 months compared with that collected just after surgery in the operating room |
| SIA | month 3 | Surgically induced astigmatism (SIA) and comparison between the 2 hospitals participating in the study |
| questionnaire IOLSAT | month 3 | questionnaire for addiction to glasses for intermediate vision and near vision (IOLSAT) : minimum 0% (no glasses needed, best outcome), to maximum 100% (glasses needed, worse outcome) |
| McAlinden questionnaire | month 3 | questionnaire for the evaluation of visual disturbances (McAlinden): minimum 0/90 and maximum 90/90 (worse outcome) |
| binocular uncorrected visual acuity | months 1 and 3 | Binocular uncorrected visual acuity (UCVA) from far to 4 m, intermediate at 66 cm, near at 40 cm. |
Outcome results
None listed