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Sensitivity of the Home Macular Perimeter (HMP)

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00604071
First received: January 10, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  Purpose

estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD


Condition
Age Related Macular Degeneration
Choroidal Neovascularization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 Month ] [ Designated as safety issue: No ]
  • Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

62 completed subjects with new choroidal neovascularization AMD in at least one eye

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604071

Locations
United States, Florida
Central Florida Retina Institute
Lakeland, Florida, United States, 33805
Retina care specialists
Palm Beach Gardens, Florida, United States, 33410
International Eye Center
Tampa, Florida, United States, 33603
Center for Retina & Macular Disease
Winter Haven, Florida, United States, 33880
United States, Minnesota
Edina Retina Consultants
Edina, Minnesota, United States, 55435
United States, New Jersey
Retina Vitreous Center
New Brunswick, New Jersey, United States, 08901
Foxman Foxman & Margolis
Northfield, New Jersey, United States, 08225
Harkness Eye institute
W. New York, New Jersey, United States, 10032
United States, North Carolina
Charlotte Eye Ear Nose & Throat
Charlotte, North Carolina, United States, 28210
United States, Virginia
Virginia Retina Center
Leesburg, Virginia, United States, 20176
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Neil Bressler, Prof. JHMC
  More Information

Additional Information:
sponsor web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Osnat Ehrman, Notal Vision
ClinicalTrials.gov Identifier: NCT00604071     History of Changes
Other Study ID Numbers: HMP-V4, 20071801
Study First Received: January 10, 2008
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:
HMP, CNV, PHP, HPHP, AMD

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 23, 2013