Clinical trial NCT00604071: Sensitivity of the Home Macular Perimeter (HMP)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Choroidal Neovascularization
Keywords: HMP, CNV, PHP, HPHP, AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 62 completed subjects with new choroidal neovascularization AMD in at least one eye

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 3 month
Secondary outcomes:
measure: 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
timeFrame: 3 month
measure: 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
timeFrame: 3 Month
measure: Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy
timeFrame: 3 month
measure: 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.
timeFrame: 3 month
measure: 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).
timeFrame: 3 month
measure: 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
timeFrame: 3 month
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: Central Florida Retina Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina care specialists
state: Florida
city: Tampa
country: United States
facility: International Eye Center
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina & Macular Disease
state: Florida
city: Edina
country: United States
facility: Edina Retina Consultants
state: Minnesota
city: New Brunswick
country: United States
facility: Retina Vitreous Center
state: New Jersey
city: Northfield
country: United States
facility: Foxman Foxman & Margolis
state: New Jersey
city: W. New York
country: United States
facility: Harkness Eye institute
state: New Jersey
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat
state: North Carolina
city: Leesburg
country: United States
facility: Virginia Retina Center
state: Virginia
Study officials:
affiliation: JHMC
name: Neil Bressler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: