Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery (SISALens)

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Cataract

Treatments

Device: Fitting of ocular implant

Study type

Interventional

Funder types

Other

Identifiers

IDIL/2017/DM-01

Details and patient eligibility

About

A good efficacy as well as good rotary stability is expected with the ocular implant.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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