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
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
Not provided
Not provided
The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye with Diagnosed Glaucoma | Experimental |
| |
| Control Eye | No Intervention | This is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. | Drug | The eye not selected as the study eye will be used for comparison so both eyes will be imaged with the study devices to assess blood flow changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve Fiber Layer Plexus Capillary Density (NFLP CD) | The primary outcome measure will be change in the overall peripapillary NFLP CD measured at 6 months and 11-12 month endpoint visits compared to baseline values. | From enrollment to end of treatment at 11-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Retinal Blood Flow (TRBF) | Secondary outcome measures will include change in the TRBF measured at 6 months or 11-12 month endpoint visits compared to baseline. | From enrollment to end of treatment at 11-12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chinmay Deshpande, MS Optom | Contact | 503-494-9628 | deshpanc@ohsu.edu | |
| Denzil Romfh, OD | Contact | 503-494-4351 | romfhd@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Huang, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casey Eye Institute - Oregon Health & Science University | Portland | Oregon | 97239 | United States |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
The investigator will assign one eye to use the study drug, while the other eye (control) will remain on the clinically prescribed medication. The identity of the eye drop will be masked to both participants and study personnel who perform testing procedures or data analysis. The university research pharmacy will provide label masked bottles for each eye.
| Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. | Device | One OCT device is FDA-cleared while the other is still experimental. Both devices assess blood flow in different ways. |
|
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |