CataractNCT06067360
Evaluation of Performance of New IFIS Sleeve
A study testing IFIS sleeve in people with Cataract, run by Medicel AG.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- IFIS sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with planned cataract surgery
Who cannot join
- pregnant woman
About this study
Official title: Hydrodissection Sleeve to Aid Cataract Surgery
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- IFIS sleeve
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFIS sleeveDevice
IFIS sleeve will be inserted to prevent iris prolapse
| Study group | Role | What they receive |
|---|---|---|
| sleeve | Experimental | Evaluation of IFIS sleeve performance Receives: Device: IFIS sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The evaluation of the device is during cataract surgery, which typically is less than 10 minutes. No additional treatments or evaluations after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study startFeb 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067360
- Sponsor's protocol ID
- IFIS2023
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrodissection Sleeve to Aid Cataract Surgery
- ClinicalTrials.gov ID
- NCT06067360
- Acronym / sponsor ID
- IFIS2023
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medicel AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sleeve | Experimental | Device: IFIS sleeveEvaluation of IFIS sleeve performance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with planned cataract surgery
Key exclusion criteria (1 listed)
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFIS sleeveIFIS sleeve will be inserted to prevent iris prolapse | Device | sleeve |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing IFIS sleeve in people with Cataract, run by Medicel AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.