Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20071801 |
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
Not provided
Not provided
Not provided
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
The HMP device is intended to aid patients in identifying their visual abnormalities and in addition to their own symptoms or Amsler grid use and aid in their prompt referral to eye care professional examination so clinical diagnosis can be made. As such the goal of the clinical plan is to demonstrate that patients who have CNV do demonstrate visual field abnormalities when tested with the HMP
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based in cases where both graders, prior to any adjudication process determined the presence of CNV | 3 month | |
| Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based on cases where both graders, prior to any adjudication process, and biomicroscopic finding determined the presence of CNV |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
62 completed subjects with new choroidal neovascularization AMD in at least one eye
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neil Bressler, Prof. | JHMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Florida Retina Institute | Lakeland | Florida | 33805 | United States | ||
| Retina care specialists |
Not provided
| Label | URL |
|---|---|
| sponsor web site | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 Month |
| Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy | 3 month |
| Estimate the sensitivity of the Amsler grid test in identifying functional changes in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and fluorescein angiograms. | 3 month |
| Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD for each of three classifications of CNV lesions (occult, minimally classic and predominantly classic). | 3 month |
| Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD which were either minimally classic or occult and where the physician elected to treatment over observation | 3 month |
| Palm Beach Gardens |
| Florida |
| 33410 |
| United States |
| International Eye Center | Tampa | Florida | 33603 | United States |
| Center for Retina & Macular Disease | Winter Haven | Florida | 33880 | United States |
| Edina Retina Consultants | Edina | Minnesota | 55435 | United States |
| Retina Vitreous Center | New Brunswick | New Jersey | 08901 | United States |
| Foxman Foxman & Margolis | Northfield | New Jersey | 08225 | United States |
| Harkness Eye institute | West New York | New Jersey | 10032 | United States |
| Charlotte Eye Ear Nose & Throat | Charlotte | North Carolina | 28210 | United States |
| Virginia Retina Center | Leesburg | Virginia | 20176 | United States |
| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |