Intraoperative Floppy Iris SyndromePhase 2NCT03760185
Pupil Dilation for Treatment of IFIS
A Phase 2 study testing Brimonidine Tartrate in people with Intraoperative Floppy Iris Syndrome, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intraoperative Floppy Iris Syndrome
- What is being tested?
- Brimonidine Tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 25 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adults (18 years old or greater) 3. History of having taken, or currently taking any systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops themselves TID for 7 days
Who cannot join
- Subjects with untreated hypertension or baseline BP >160
- Subjects with Thyrotoxicosis
- Pregnant women or women trying to conceive
- Prisoners
- Inability consent
- Subjects with anatomical narrow angles or who have never had a dilated eye exam
Show all 10Show fewer
- Subjects currently prescribed brimonidine tartrate for glaucoma
- Subjects who take topical or systemic alpha agonists
- Patients who take monoamine oxidase (MAO) inhibitors
- Patients with known severe cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
Read the detailed description
This study explores the effects that medication can have on increasing pupil dilation. Pupil dilation size is important for operative eye procedures. Decreased pupil size is related to increased complication risks in eye surgery. By exploring novel pupil dilation techniques, there is a potential to counteract the effects of poor pupil dilation that is caused by medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused by BPH medications. This study evaluates treatment methods targeting IFIS.
- Conditions
- Intraoperative Floppy Iris Syndrome
- Being tested
- Brimonidine Tartrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine TartrateDrug
Also called "Eye Drops"
All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine Tartrate 0.2% | Experimental | One eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment. Receives: Drug: Brimonidine Tartrate |
| Control - untreated | No intervention | The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye
Measured: 45 minutes post dilation after 7 days of treatment
Secondary outcomes (1)
Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study
Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study
Measured: 45 minutes post dilation after 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start4 Jan 2019
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristos Ifantides, MD, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760185
- Sponsor's protocol ID
- 18-1713
- Status last verified
- Mar 2022
- First submitted
- 28 Nov 2018
- Last updated
- 20 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome
- ClinicalTrials.gov ID
- NCT03760185
- Acronym / sponsor ID
- 18-1713
- Conditions
- Intraoperative Floppy Iris Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Posted 20 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
Detailed description
This study explores the effects that medication can have on increasing pupil dilation. Pupil dilation size is important for operative eye procedures. Decreased pupil size is related to increased complication risks in eye surgery. By exploring novel pupil dilation techniques, there is a potential to counteract the effects of poor pupil dilation that is caused by medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused by BPH medications. This study evaluates treatment methods targeting IFIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
| Arm | Type | Receives |
|---|---|---|
| Brimonidine Tartrate 0.2% | Experimental | Drug: Brimonidine TartrateOne eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment. |
| Control - untreated | No intervention | –The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adults (18 years old or greater) 3. History of having taken, or currently taking any systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops themselves TID for 7 days
Key exclusion criteria (10 listed)
- Subjects with untreated hypertension or baseline BP >160
- Subjects with Thyrotoxicosis
- Pregnant women or women trying to conceive
- Prisoners
- Inability consent
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 |
|---|---|---|
| Brimonidine TartrateAlso: "Eye Drops"All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation. | Drug | Brimonidine Tartrate 0.2% |
Primary outcome
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
Time frame: 45 minutes post dilation after 7 days of treatment
The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye
1 secondary outcome
Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study
Time frame: 45 minutes post dilation after 7 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Intraoperative Floppy Iris Syndrome
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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.
Cristos Ifantides, MD principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brimonidine Tartrate in people with Intraoperative Floppy Iris Syndrome, run by Denver Health and Hospital Authority at 1 site in United States.
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 10 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 Apr 2022. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye (time frame: 45 minutes post dilation after 7 days of treatment). 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 20 Apr 2022.