Evaluation of Performance of New IFIS Sleeve

Medicel AG (Industry)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

A silicone sleeve will be used on the hydrodissection needle to avoid that the iris can prolaps through the gap between needle and incision wound.

Condition or Disease Intervention/Treatment Phase
  • Device: IFIS sleeve

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 Design

Study Type:
Anticipated Enrollment :
20 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Hydrodissection Sleeve to Aid Cataract Surgery
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: sleeve

Evaluation of IFIS sleeve performance

Device: IFIS sleeve
IFIS sleeve will be inserted to prevent iris prolapse

Outcome Measures

Primary Outcome Measures

  1. performance of IFIS sleeve to prevent iris prolapse [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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • patient with planned cataract surgery
Exclusion Criteria:
  • pregnant woman

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Medicel AG


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Medicel AG
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • IFIS2023
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023