Sensitivity and Specificity of the Home Macular Perimeter (HMP) - Tabular View

Tracking Information

First Received Date ^ICMJE

January 6, 2008

Last Updated Date

January 27, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00595998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Sensitivity and Specificity of the Home Macular Perimeter (HMP)

Official Title ^ICMJE

Sensitivity and Specificity of the Home Macular Perimeter

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Retrospective

Condition ^ICMJE

Age Related Macular Degeneration

Intervention ^ICMJE

Study Arms / Comparison Groups

newly onset CNV secondary to AMD
Intermediate AMD

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00595998

Responsible Party

Dr. Josef Ferenzc, Meir Medical center

Study ID Numbers ^ICMJE

HMP-SS1, MMC-0206-07

Study Sponsor ^ICMJE

Notal Vision Ltd

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Josef Mr Ferenzc, MD

Meir Medical Center

Information Provided By

Notal Vision Ltd

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP