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

N/ACompletedNCT03356847

Centre Hospitalier Universitaire de Nīmes20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

Fitting of ocular implantDEVICE

Removal of natural lens and replacement with a SISA monofocal intraocular implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Nimes

Nîmes, France

Outcomes

Primary Outcomes

Rotational stability of SISA monofocal implant following cataracts surgery

rotation in degrees measured by Labview software

Time frame: 4 Months

Secondary Outcomes

Rotational stability of SISA monofocal implant following cataracts surgery

rotation in degrees measured by Labview software

Time frame: Day 0

Rotational stability of SISA monofocal implant following cataracts surgery

rotation in degrees measured by Labview software

Time frame: Day 7

Rotational stability of SISA monofocal implant following cataracts surgery

rotation in degrees measured by Labview software

Time frame: 1 Month

Centering of SISA monofocal implant

Distance in mm between centers of the coreal and optic ellipses

Time frame: Day 0

Centering of SISA monofocal implant

Distance in mm between centers of the coreal and optic ellipses

Time frame: Day 7

Centering of SISA monofocal implant

Distance in mm between centers of the coreal and optic ellipses

Time frame: Month 1

Centering of SISA monofocal implant

Distance in mm between centers of the coreal and optic ellipses

Time frame: Month 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.