Sensitivity of the Home Macular Perimeter (HMP)
- Conditions
- Age Related Macular DegenerationChoroidal Neovascularization
- Registration Number
- NCT00604071
- Lead Sponsor
- Notal Vision Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (10)
Charlotte Eye Ear Nose & Throat
🇺🇸Charlotte, North Carolina, United States
Virginia Retina Center
🇺🇸Leesburg, Virginia, United States
Edina Retina Consultants
🇺🇸Edina, Minnesota, United States
International Eye Center
🇺🇸Tampa, Florida, United States
Retina Vitreous Center
🇺🇸New Brunswick, New Jersey, United States
Central Florida Retina Institute
🇺🇸Lakeland, Florida, United States
Center for Retina & Macular Disease
🇺🇸Winter Haven, Florida, United States
Foxman Foxman & Margolis
🇺🇸Northfield, New Jersey, United States
Retina care specialists
🇺🇸Palm Beach Gardens, Florida, United States
Harkness Eye institute
🇺🇸W. New York, New Jersey, United States