Sensitivity of the Home Macular Perimeter (HMP)
Information source: Notal Vision Ltd
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Age Related Macular Degeneration; Choroidal Neovascularization
Phase: N/A
Status: Completed
Sponsored by: Notal Vision Ltd Official(s) and/or principal investigator(s): Neil Bressler, Prof., Principal Investigator, Affiliation: JHMC
Summary
estimate the sensitivity of the HMP test in identifying visual field functional defects in
subjects with CNV secondary to AMD
Clinical Details
Official title: Sensitivity of the Home Macular Perimeter (HMP) in the Detection of Visual Field Abnormalities in Patients With Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)- PILOT Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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
Secondary outcome: 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 CNVEstimate 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 Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy 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. 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). 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
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
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Central Florida Retina Institute, Lakeland, Florida 33805, United States
Retina care specialists, 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, W. 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
Additional Information
sponsor web site
Starting date: November 2007
Last updated: April 13, 2015
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