Clinical trial NCT03356847: Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Official title: Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Rotational stability of SISA monofocal implant following cataracts surgery
timeFrame: 4 Months
Secondary outcomes:
measure: Rotational stability of SISA monofocal implant following cataracts surgery
timeFrame: Day 0
measure: Rotational stability of SISA monofocal implant following cataracts surgery
timeFrame: Day 7
measure: Rotational stability of SISA monofocal implant following cataracts surgery
timeFrame: 1 Month
measure: Centering of SISA monofocal implant
timeFrame: Day 0
measure: Centering of SISA monofocal implant
timeFrame: Day 7
measure: Centering of SISA monofocal implant
timeFrame: Month 1
measure: Centering of SISA monofocal implant
timeFrame: Month 4
measure: Refractive precision
timeFrame: Day 7
measure: Refractive precision
timeFrame: Month 1
measure: Refractive precision
timeFrame: Month 4
measure: Visual acuity with and without correction
timeFrame: Day 7
measure: Visual acuity with and without correction
timeFrame: Month 1
measure: Visual acuity with and without correction
timeFrame: Month 4
measure: Perioperative complications
timeFrame: Day 0
measure: Postoperative complications
timeFrame: Day 7
measure: Occurrence of undesirable events,
timeFrame: Day 0
measure: Occurrence of undesirable events,
timeFrame: Day 7
measure: Occurrence of undesirable events,
timeFrame: Month 1
measure: Occurrence of undesirable events,
timeFrame: Month 7
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References: