SISALens: Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Study Details
Study Description
Brief Summary
A good efficacy as well as good rotary stability is expected with the ocular implant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SISA implant
|
Device: Fitting of ocular implant
Removal of natural lens and replacement with a SISA monofocal intraocular implant
|
Outcome Measures
Primary Outcome Measures
- Rotational stability of SISA monofocal implant following cataracts surgery [4 Months]
rotation in degrees measured by Labview software
Secondary Outcome Measures
- Rotational stability of SISA monofocal implant following cataracts surgery [Day 0]
rotation in degrees measured by Labview software
- Rotational stability of SISA monofocal implant following cataracts surgery [Day 7]
rotation in degrees measured by Labview software
- Rotational stability of SISA monofocal implant following cataracts surgery [1 Month]
rotation in degrees measured by Labview software
- Centering of SISA monofocal implant [Day 0]
Distance in mm between centers of the coreal and optic ellipses
- Centering of SISA monofocal implant [Day 7]
Distance in mm between centers of the coreal and optic ellipses
- Centering of SISA monofocal implant [Month 1]
Distance in mm between centers of the coreal and optic ellipses
- Centering of SISA monofocal implant [Month 4]
Distance in mm between centers of the coreal and optic ellipses
- Refractive precision [Day 7]
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
- Refractive precision [Month 1]
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters;
- Refractive precision [Month 4]
Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters
- Visual acuity with and without correction [Day 7]
Early Treatment Diabetic Retinopathy Study scale, logMAR
- Visual acuity with and without correction [Month 1]
Early Treatment Diabetic Retinopathy Study scale, logMAR
- Visual acuity with and without correction [Month 4]
Early Treatment Diabetic Retinopathy Study scale, logMAR
- Perioperative complications [Day 0]
Yes/no
- Postoperative complications [Day 7]
Yes/no
- Occurrence of undesirable events, [Day 0]
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,
- Occurrence of undesirable events, [Day 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,
- Occurrence of undesirable events, [Month 1]
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,
- 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,
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Nimes | Nîmes | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IDIL/2017/DM-01