Status:
COMPLETED
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A good efficacy as well as good rotary stability is expected with the ocular implant.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03356847
Start Date
September 29 2017
End Date
July 11 2018
Last Update
August 2 2018
Active Locations (1)
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1
CHU Nimes
Nîmes, France, 30029