- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067360
Evaluation of Performance of New IFIS Sleeve
Hydrodissection Sleeve to Aid Cataract Surgery
Study Overview
Detailed Description
Cataract surgey is a common operation approximately 25 million pocedures per year worldwide. An essential step of the procedure is hydrodissection where fluid is forced into the eye through a cannula to free the cataract from its capsule. A serious and potential sight threatening complication of hydrodissection is iris prolapse, where the iris comes out of the wound. The overall incidence of iris prolapse during cataract surgery is 0.9% and higher in patients with intraoperative floppy iris syndrome (IFIS) at 11.9% , small pupils and small eyes. Patients on Tamsulosin medication with a Full Set of Project Data IRAS Version 6.3.3 5 DRAFT pupil less than 7.5mm have a 79% risk of prolapse Iris prolapse most often occurs during hydrodissection because the hydrodissection cannula is smaller (approx.1mm) than the wound (2.2-2.7mm) it is introduced through. Therefore the iris can be forced out / prolapse through this gap by the forced injection of fluid.
Traditional methods such as phenylephrine injection into the eye have varying effects can be unlicensed and possibly increase the prolapse risk. Mechanical pupil stretching can permanently damage the iris with complications.
Phacosleeve hydrodissection where the wound is sealed by a phacosleeve and the hydrodissecting irrigation cannula introduced through the sleeve or from side port /incison. The phacosleeve is not designed for this. This study is to use a purpose made tapered sleeve by Medicel in the same fashion as the current phacosleeve.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patient with planned cataract surgery
Exclusion Criteria:
- pregnant woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sleeve
Evaluation of IFIS sleeve performance
|
IFIS sleeve will be inserted to prevent iris prolapse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
performance of IFIS sleeve to prevent iris prolapse
Time Frame: The evaluation of the device is during cataract surgery, which typically is less than 10 minutes. No additional treatments or evaluations after the surgery.
|
performance of the IFIS sleeve to successfully prevent from iris prolapse: Iris prolaps is a distinct complication that can occurr during cataract surgery.
For each treatment, the surgeon will protocol, whether a prolaps occurred during the surgical procedure.
The primary outcome is the number of prolaps cases over all surgeries.
|
The evaluation of the device is during cataract surgery, which typically is less than 10 minutes. No additional treatments or evaluations after the surgery.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFIS2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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