Sensitivity and Specificity of the Home Macular Perimeter (HMP)

NCT ID: NCT00595998

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-11-30

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.

Conditions

Age Related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

newly onset CNV secondary to AMD

No interventions assigned to this group

2

Intermediate AMD

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Notal Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Meir Medical center

Principal Investigators

Josef Mr Ferenzc, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Related Links

http://www.notalvision.com

Sponsor Site

Other Identifiers

MMC-0206-07

Identifier Type: -

Identifier Source: secondary_id

HMP-SS1

Identifier Type: -

Identifier Source: org_study_id