Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
SISALens
1 other identifier
interventional
20
1 country
1
Brief Summary
A good efficacy as well as good rotary stability is expected with the ocular implant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedFirst Posted
Study publicly available on registry
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2018
CompletedAugust 2, 2018
November 1, 2017
10 months
September 29, 2017
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rotational stability of SISA monofocal implant following cataracts surgery
rotation in degrees measured by Labview software
4 Months
Secondary Outcomes (19)
Rotational stability of SISA monofocal implant following cataracts surgery
Day 0
Rotational stability of SISA monofocal implant following cataracts surgery
Day 7
Rotational stability of SISA monofocal implant following cataracts surgery
1 Month
Centering of SISA monofocal implant
Day 0
Centering of SISA monofocal implant
Day 7
- +14 more secondary outcomes
Study Arms (1)
SISA implant
EXPERIMENTALInterventions
Removal of natural lens and replacement with a SISA monofocal intraocular implant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Nimes
Nîmes, 30029, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2017
First Posted
November 29, 2017
Study Start
September 29, 2017
Primary Completion
July 11, 2018
Study Completion
July 11, 2018
Last Updated
August 2, 2018
Record last verified: 2017-11