Age Related Macular Degeneration, Choroidal Neovascularization
Conditions
Keywords
HMP, CNV, PHP, HPHP, AMD
Brief summary
estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
Detailed description
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
Interventions
None listed
Sponsors
Notal Vision Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Capable and willing to sign a consent form and participate in the study * subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV * Age \>50 years * VA with habitual correction \>20/200 in study eye * Familiar with computer usage
Exclusion criteria
* Evidence of macular disease other than AMD or glaucoma in the study eye * Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA * Any non-macular related ocular surgery performed within 3 months prior to study entry in the targeted eye * Inability to tolerate intravenous FA * Participation in another study with the exclusion of AREDS study
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 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 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 |
| 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 |
Countries
United States
Outcome results
None listed