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

Study Overview
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Brief Summary
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A good efficacy as well as good rotary stability is expected with the ocular implant.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Fitting of ocular implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SISA implant<br> | Device: Fitting of ocular implant<br>* Removal of natural lens and replacement with a SISA monofocal intraocular implant<br>|

What is the study measuring?
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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 |