Sensitivity of the Home Macular Perimeter (HMP)

Notal Vision Ltd.99 enrolled

Overview

estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD

The HMP device is intended to aid patients in identifying their visual abnormalities and in addition to their own symptoms or Amsler grid use and aid in their prompt referral to eye care professional examination so clinical diagnosis can be made. As such the goal of the clinical plan is to demonstrate that patients who have CNV do demonstrate visual field abnormalities when tested with the HMP

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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 * 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 * Participation in another study with the exclusion of AREDS study

Locations (10)

Central Florida Retina Institute

Lakeland, Florida, United States

Retina care specialists

Palm Beach Gardens, Florida, United States

International Eye Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram

Time frame: 3 month

Secondary Outcomes

Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based in cases where both graders, prior to any adjudication process determined the presence of CNV

Time frame: 3 month

Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based on cases where both graders, prior to any adjudication process, and biomicroscopic finding determined the presence of CNV

Time frame: 3 Month

Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy

Time frame: 3 month

Estimate the sensitivity of the Amsler grid test in identifying functional changes in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and fluorescein angiograms.

Time frame: 3 month

Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD for each of three classifications of CNV lesions (occult, minimally classic and predominantly classic).

Time frame: 3 month

Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD which were either minimally classic or occult and where the physician elected to treatment over observation

Time frame: 3 month

Data from ClinicalTrials.gov

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