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

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Fitting of ocular implant

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SISA implant	Device: Fitting of ocular implant; Removal of natural lens and replacement with a SISA monofocal intraocular implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational stability of SISA monofocal implant following cataracts surgery	rotation in degrees measured by Labview software	4 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2017
• Primary Completion (ACTUAL): July 11, 2018
• Study Completion (ACTUAL): July 11, 2018

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IDIL/2017/DM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No