ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensitivity of the Home Macular Perimeter (HMP) (HMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00604071
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Age Related Macular Degeneration Choroidal Neovascularization

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

Study Type : Observational
Actual Enrollment : 99 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008


Group/Cohort
1
subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT00604071     History of Changes
Other Study ID Numbers: HMP-V4
20071801
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

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