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

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ClinicalTrials.gov Identifier: NCT00595998
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:
Notal Vision Inc.

Brief Summary:
The primary objective of this study is to estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD, and differentiate them from intermediate AMD subjects.

Condition or disease
Age Related Macular Degeneration

Detailed Description:
It is a one encounter visit in which patients are enrolled and complete the study on the same day. This will allow recruiting and testing of patients with CNV which is a dynamic disease that is most often treated on that same day. Following enrollment, patients will go through an examiner supervised tutorial followed by a self-performed HMP examination. In addition patient will undergo an Amsler grid examination, biomicroscopy, color fundus photography and fluorescein angiography. The HMP output shall be a test result that can be within or outside normal limits. Inherent to the test are reliability criteria which help to determine if the patient performed the test reliably. These consist of false positive and false negative errors. All criteria for normal limits and reliable performance are set prior to study initiation. The outcome measures for the study are the sensitivity in identifying visual functional defects in patients with CNV.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sensitivity and Specificity of the Home Macular Perimeter
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
1
newly onset CNV secondary to AMD
2
Intermediate AMD



Primary Outcome Measures :
  1. estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD and differentiate them from intermediate AMD subjects. [ Time Frame: 1 Month ]


Information from the National Library of Medicine

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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
The study population will include 30 subjects suspected to have newly onset CNV secondary to AMD in at least one eye, or Intermediate AMD in at least one eye, and who consent to participate in the study.
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 or Intermediate AMD patients (defined as the presence of at least one large drusen or more than 20 medium size drusen)
  • 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
  • GA in the study eye
  • 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): NCT00595998


Locations
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Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Notal Vision Ltd.
Investigators
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Principal Investigator: Josef Mr Ferenzc, MD Meir Medical Center
Additional Information:
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Responsible Party: Dr. Josef Ferenzc, Meir Medical center
ClinicalTrials.gov Identifier: NCT00595998    
Other Study ID Numbers: HMP-SS1
MMC-0206-07
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009
Keywords provided by Notal Vision Inc.:
AMD, HMP, PHP
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases