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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Fitting of ocular implant

• Registration Number: NCT03356847
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-29
• Study First Submitted: 2017-09-29
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SISA implant	Fitting of ocular implant	-

Primary Outcome Measures

Name	Time	Method
Rotational stability of SISA monofocal implant following cataracts surgery	4 Months	rotation in degrees measured by Labview software

Secondary Outcome Measures

Name	Time	Method
Rotational stability of SISA monofocal implant following cataracts surgery	1 Month	rotation in degrees measured by Labview software
Perioperative complications	Day 0	Yes/no
Centering of SISA monofocal implant	Month 4	Distance in mm between centers of the coreal and optic ellipses
Visual acuity with and without correction	Month 4	Early Treatment Diabetic Retinopathy Study scale, logMAR
Refractive precision	Month 4	Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
Postoperative complications	Day 7	Yes/no
Occurrence of undesirable events,	Month 7	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,

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France