Cataract
Conditions
Brief summary
A good efficacy as well as good rotary stability is expected with the ocular implant.
Interventions
DEVICEFitting of ocular implant
Removal of natural lens and replacement with a SISA monofocal intraocular implant
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient must be available for 6 months follow-up * The patient it aged at least 18 years * Patient requires surgery for cataracts with removal of the opacified natural lens and replacement with the SISA implant, according to standard procedure * The surgery is elective * The patient has clear and non-pathological corneas * The patient needs an implant strength (LIO) between +10D and +30D * Corneal astigmatism less than or equal to 1.50D in the eye to be operated (or cataract eye
Exclusion criteria
* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The patient is under safeguard of justice or state guardianship * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is pregnant or breastfeeding * The patient has other ocular comorbidities with poor visual acuity prognosis postoperatively * Previous ocular trauma or surgery * Dilation of the pupil \<7mm with mydriatic drugs * Implantation with a rhexis that does not cover the optic of the implant by more than 1 cadranel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotational stability of SISA monofocal implant following cataracts surgery | 4 Months | rotation in degrees measured by Labview software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rotational stability of SISA monofocal implant following cataracts surgery | Day 0 | rotation in degrees measured by Labview software |
| Centering of SISA monofocal implant | Day 0 | Distance in mm between centers of the coreal and optic ellipses |
| Visual acuity with and without correction | Day 7 | Early Treatment Diabetic Retinopathy Study scale, logMAR |
| Refractive precision | Day 7 | Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters |
| Postoperative complications | Day 7 | Yes/no |
| Occurrence of undesirable events, | Day 0 | Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted, |
| Perioperative complications | Day 0 | Yes/no |
Countries
France
Outcome results
None listed