Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine Tartrate | Drug | All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 45 minutes post dilation after 7 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 45 minutes post dilation after 7 days of treatment |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cristos Ifantides, MD | Denver Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health | Denver | Colorado | 80204 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be screened at their annual eye examination at the hospital eye clinic.
| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine Tartrate 0.2% | All enrolled subjects will receive the interventional drug, Brimonidine tartrate 0.2%, to be applied to ONE eye only. |
| FG001 | Control- Untreated | All subjects enrolled will have one eye serve as a control and will not receive the Brimonidine Tartrate 0.2% treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | One participant did not show for their follow-up visit after treatment. | Posted | Mean | Standard Deviation | millimeters | 45 minutes post dilation after 7 days of treatment | eyes | eyes |
|
up to 30 days from enrollment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brimonidine Tartrate 0.2% | The eye that was treated with Brimonidine Tartrate 0.2%. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery- Cryoablation of prostate | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney & Urinary tract | Renal and urinary disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cristos Ifantides | Denver Health and Hospital Authority | 303-436-4949 | Cristos.Ifantides@dhha.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2019 | Feb 6, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2019 | Feb 6, 2022 | ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pre-Study Treatment Pupil Diameter Dilated | Mean | Standard Deviation | milimeters |
|
|
|
| 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 | 1 patient did not return for their post-treatment follow-up visit | Posted | Mean | Standard Deviation | millimeters | 45 minutes post dilation after 7 days of treatment | eyes | eyes |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 2 |
| 13 |
| EG001 | Control- Untreated | The eye that was not treated with Brimonidine Tartrate 0.2%. | 0 | 13 | 1 | 13 | 2 | 13 |
| Ophthalmology - Cataracts | Eye disorders | Systematic Assessment |
|
| Cardio - MI | Cardiac disorders | Non-systematic Assessment | Patient disclosed to study PI that he had an MI and was treated at an outside hospital with a stent surgery. |
|
Not provided
Not provided
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |