Sensitivity and Specificity of the Home Macular Perimeter (HMP)

Age Related Macular Degeneration Clinical Trial

— HMP  

Official title:

Sensitivity and Specificity of the Home Macular Perimeter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595998
• Other study ID #: HMP-SS1
• Secondary ID: MMC-0206-07
• Status: Completed
• Phase: N/A
• First received: January 6, 2008
• Last updated: January 27, 2009
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 Month	No

External Links

•   Sponsor Site