Sensitivity and Specificity of the Home Macular Perimeter (HMP)

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00595998
First received: January 6, 2008
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sensitivity and Specificity of the Home Macular Perimeter

Resource links provided by NLM:


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 and differentiate them from intermediate AMD subjects. [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
newly onset CNV secondary to AMD
2
Intermediate AMD

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595998

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Josef Mr Ferenzc, MD Meir Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Josef Ferenzc, Meir Medical center
ClinicalTrials.gov Identifier: NCT00595998     History of Changes
Other Study ID Numbers: HMP-SS1, MMC-0206-07
Study First Received: January 6, 2008
Last Updated: January 27, 2009
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014