Sensitivity and Specificity of the Home Macular Perimeter (HMP)

Sponsor

Notal Vision Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00595998

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration

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 Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Sensitivity and Specificity of the Home Macular Perimeter

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 newly onset CNV secondary to AMD
2 Intermediate AMD

Outcome Measures

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. [1 Month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar Saba		Israel

Sponsors and Collaborators

Notal Vision Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Sponsor Site

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00595998

Other Study ID Numbers:

HMP-SS1
MMC-0206-07

First Posted:

Jan 16, 2008

Last Update Posted:

Jan 28, 2009

Last Verified:

Jan 1, 2009

Keywords provided by , ,

AMD, HMP, PHP

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Jan 28, 2009