Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery

Centre Hospitalier Universitaire de Nīmes1 site in 1 country20 target enrollmentSeptember 29, 2017

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 20
Locations: 1
Primary Endpoint: Rotational stability of SISA monofocal implant following cataracts surgery
Status: Completed
Last Updated: 7 years ago

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

Registry

clinicaltrials.gov

Start Date

September 29, 2017

End Date

July 11, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

•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

•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

Rotational stability of SISA monofocal implant following cataracts surgery

Time Frame: 4 Months

rotation in degrees measured by Labview software

Centering of SISA monofocal implant(Month 4)
Visual acuity with and without correction(Month 4)
Refractive precision(Month 4)
Postoperative complications(Day 7)
Rotational stability of SISA monofocal implant following cataracts surgery(1 Month)
Perioperative complications(Day 0)
Occurrence of undesirable events,(Month 7)