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

January 27, 2009 updated by: Notal Vision Ltd.

Sensitivity and Specificity of the Home Macular Perimeter

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Investigators

  • Principal Investigator: Josef Mr Ferenzc, MD, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

January 6, 2008

First Submitted That Met QC Criteria

January 6, 2008

First Posted (ESTIMATE)

January 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMP-SS1
  • MMC-0206-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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