Sensitivity and Specificity of the Home Macular Perimeter (HMP)

Notal Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT00595998

HMP-SS1

MMC-0206-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

42 participants in 2 patient groups

1

Description:

newly onset CNV secondary to AMD

2

Description:

Intermediate AMD