Intraoperative Floppy Iris Syndrome
Conditions
Brief summary
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.
Interventions
All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
Sponsors
Denver Health and Hospital Authority
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
1. Subjects with untreated hypertension or baseline BP \>160 2. Subjects with Thyrotoxicosis 3. Pregnant women or women trying to conceive 4. Prisoners 5. Inability consent 6. Subjects with anatomical narrow angles or who have never had a dilated eye exam 7. Subjects currently prescribed brimonidine tartrate for glaucoma 8. Subjects who take topical or systemic alpha agonists 9. Patients who take monoamine oxidase (MAO) inhibitors 10. Patients with known severe cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 45 minutes post dilation after 7 days of treatment | 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 |
Countries
United States
Participant flow
Recruitment details
Patients will be screened at their annual eye examination at the hospital eye clinic.
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients in this arm will receive eye drops to be applied to one eye only. The alternative eye will not receive any eye drops and as such will serve as the control.
Brimonidine Tartrate: All subjects will apply brimonidine tartrate to one eye only for the duration of study participation. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | All Patients | — |
|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 10.1 | — |
| Pre-Study Treatment Pupil Diameter Dilated | 6.50 milimeters STANDARD_DEVIATION 1.28 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 2 / 13 | 2 / 13 |
| serious Total, serious adverse events | 1 / 13 | 1 / 13 |
Outcome results
Primary
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
Time frame: 45 minutes post dilation after 7 days of treatment
Population: One participant did not show for their follow-up visit after treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brimonidine Tartrate 0.2% | Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye | 6.76 millimeters | Standard Deviation 2.57 |
| Control - Untreated | Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye | 7.17 millimeters | Standard Deviation 1.2 |
Secondary
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
Time frame: 45 minutes post dilation after 7 days of treatment
Population: 1 patient did not return for their post-treatment follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brimonidine Tartrate 0.2% | 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 | 0.39 millimeters | Standard Deviation 2.2 |
| Control - Untreated | 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 | 0.91 millimeters | Standard Deviation 1.53 |