Intraoperative Floppy Iris SyndromePhase 4NCT06266962
Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome
A Phase 4 study testing 1% Atropine drops and Epinephrine in people with Intraoperative Floppy Iris Syndrome and Cataract, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract
- What is being tested?
- 1% Atropine drops and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2020to 30 Sep 2022
- Phase
- Phase 4
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age-related cataract
- age over 18 years
- men with diagnosed benign prostatic hyperplasia
- history of having taken, or currently taking any systemic α1-adrenergic receptor antagonists for low urinary tract symptoms
- performing of pre-operative examination before cataract surgery
- signed informed consent
Who cannot join
- presence of any pupil deformity due to e.g. post-traumatic condition
- iris defect of any aetiology
- status post anterior uveitis
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Ophthalmology, University Hospital Olomouc
Olomouc
About this study
Official title: Comparing the Efficiency of Two Prophylactic Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine.
Read the detailed description
Intraoperative Floppy Iris Syndrome (IFIS) is a complication that may develop during cataract surgery. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. It is characterised by an unstable iris whose increased elasticity may lead to a number of complications during cataract extraction with a negative impact on vision outcomes. Basic features of IFIS are a 'floppy' iris that 'ripples' in irrigation, insufficiently inducible mydriasis with progressive intraoperative miosis (despite repeated application of mydriatics) and the tendency of the iris to prolapse into the phacoemulsification probe.
IFIS is a complication that makes surgery more difficult for the eye surgeon. There is a risk of intraoperative conditions such as rupture of the posterior capsule with lens masses luxation into the vitreous body, damage to the iris by surgical instruments, damage to the endothelium with washout of endothelial cells, hyphaema, or prolapse of the vitreous body into the anterior chamber.
There are several surgical approaches to prevent the development of IFIS and facilitate easier management of the entire cataract extraction in unstable iris. The investigators recommend patients apply 1% atropine drops twice a day for one week during the pre-operative period. A more elegant method is the administration of epinephrine into the anterior chamber at the beginning of the cataract surgery. The aim of this study is to evaluate the effectiveness of two mydriatic agents - the administration of atropine drops and the instillation of epinephrine into the anterior chamber and to compare their effectiveness in preventing IFIS.
- Conditions
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Adrenergic Receptor Antagonist Adverse Reaction
- Being tested
- 1% Atropine drops, Epinephrine
- Keywords
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Atropine, Epinephrine, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Alpha1-adrenergic receptor antagonists, Tamsulosin
- Medical subject headings
- Cataract, Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Atropine dropsDrug
Patients administered 1% Atropine drops twice a day for a week before the cataract surgery.
EpinephrineDrug
Patients underwent the instillation of epinephrine into the anterior chamber at the beginning of the cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1% Atropine drops | Active comparator | Not described Receives: Drug: 1% Atropine drops |
| Epinephrine | Active comparator | Not described Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of IFIS
Development of IFIS - yes/no.
Measured: intraoperative
Severity of IFIS
Determination of severity of IFIS - mild/moderate/severe.
Measured: intraoperative
Incidence of intraoperative complications
To find out if there are any intraoperative complications in either group (%) and what the complications are (rupture of the posterior capsule of the lens, intraoperative hypotonia, iris defect atc.)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jul 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative Floppy Iris SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Zuzana Schreiberova, University Hospital Olomouc
- Investigators
- Miroslava Maluskova, MD, FEBO, Principal investigator, University Hospital Olomouc and Palacky University Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266962
- Sponsor's protocol ID
- 3/24
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maluskova M, Maresova K, Schreiberova Z, Paskova B, Karhanova M. Comparing the efficiency of two prophylactic approaches in patients at risk of developing Intraoperative Floppy Iris Syndrome. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2025 Sep 19. doi: 10.5507/bp.2025.025. Online ahead of print.
PubMed 40977319
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficiency of Two Prophylactic Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome
- ClinicalTrials.gov ID
- NCT06266962
- Acronym / sponsor ID
- 3/24
- Conditions
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Adrenergic Receptor Antagonist Adverse Reaction
- Keywords
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Atropine, Epinephrine, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Alpha1-adrenergic receptor antagonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 20 Feb 2024 (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.
Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine.
Detailed description
Intraoperative Floppy Iris Syndrome (IFIS) is a complication that may develop during cataract surgery. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. It is characterised by an unstable iris whose increased elasticity may lead to a number of complications during cataract extraction with a negative impact on vision outcomes. Basic features of IFIS are a 'floppy' iris that 'ripples' in irrigation, insufficiently inducible mydriasis with progressive intraoperative miosis (despite repeated application of mydriatics) and the tendency of the iris to prolapse into the phacoemulsification probe.
IFIS is a complication that makes surgery more difficult for the eye surgeon. There is a risk of intraoperative conditions such as rupture of the posterior capsule with lens masses luxation into the vitreous body, damage to the iris by surgical instruments, damage to the endothelium with washout of endothelial cells, hyphaema, or prolapse of the vitreous body into the anterior chamber.
There are several surgical approaches to prevent the development of IFIS and facilitate easier management of the entire cataract extraction in unstable iris. The investigators recommend patients apply 1% atropine drops twice a day for one week during the pre-operative period. A more elegant method is the administration of epinephrine into the anterior chamber at the beginning of the cataract surgery. The aim of this study is to evaluate the effectiveness of two mydriatic agents - the administration of atropine drops and the instillation of epinephrine into the anterior chamber and to compare their effectiveness in preventing IFIS.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% Atropine drops | Active comparator | Drug: 1% Atropine drops |
| Epinephrine | Active comparator | Drug: Epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age-related cataract
- age over 18 years
- men with diagnosed benign prostatic hyperplasia
- history of having taken, or currently taking any systemic α1-adrenergic receptor antagonists for low urinary tract symptoms
- performing of pre-operative examination before cataract surgery
Key exclusion criteria (3 listed)
- presence of any pupil deformity due to e.g. post-traumatic condition
- iris defect of any aetiology
- status post anterior uveitis
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 |
|---|---|---|
| 1% Atropine dropsPatients administered 1% Atropine drops twice a day for a week before the cataract surgery. | Drug | 1% Atropine drops |
| EpinephrinePatients underwent the instillation of epinephrine into the anterior chamber at the beginning of the cataract surgery. | Drug | Epinephrine |
Primary outcome
Development of IFIS
Time frame: intraoperative
Development of IFIS - yes/no.
Severity of IFIS
Time frame: intraoperative
Determination of severity of IFIS - mild/moderate/severe.
Incidence of intraoperative complications
Time frame: intraoperative
To find out if there are any intraoperative complications in either group (%) and what the complications are (rupture of the posterior capsule of the lens, intraoperative hypotonia, iris defect atc.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40977319Maluskova M, Maresova K, Schreiberova Z, Paskova B, Karhanova M. Comparing the efficiency of two prophylactic approaches in patients at risk of developing Intraoperative Floppy Iris Syndrome. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2025 Sep 19. doi: 10.5507/bp.2025.025. Online ahead of print.
Related trials for Intraoperative Floppy Iris Syndrome
Not yet recruitingPhase 4
Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
Benign Prostatic Hyperplasia, Tamsulosin
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.
Miroslava Maluskova, MD, FEBO principal investigator
University Hospital Olomouc and Palacky University Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% Atropine drops and Epinephrine in people with Intraoperative Floppy Iris Syndrome and Cataract, run by University Hospital Olomouc at 1 site in Czechia.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of IFIS (time frame: intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266962, which also lists 1 linked publication.
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 20 Feb 2024.