NCT06067360

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

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 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

September 21, 2023

Last Update Submit

September 28, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • performance of IFIS sleeve to prevent iris prolapse

    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.

Study Arms (1)

sleeve

EXPERIMENTAL

Evaluation of IFIS sleeve performance

Device: IFIS sleeve

Interventions

IFIS sleeveDEVICE

IFIS sleeve will be inserted to prevent iris prolapse

sleeve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with planned cataract surgery

You may not qualify if:

  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 4, 2023

Study Start

February 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share