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

Cataract Clinical Trial

— SISALens  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356847
• Other study ID #: IDIL/2017/DM-01
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: July 11, 2018

Study information

• Verified date: November 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Fitting of ocular implant
Removal of natural lens and replacement with a SISA monofocal intraocular implant

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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