Sensitivity of the Home Macular Perimeter (HMP)

Age Related Macular Degeneration Clinical Trial

— HMP  

Official title:

Sensitivity of the Home Macular Perimeter (HMP) in the Detection of Visual Field Abnormalities in Patients With Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)- PILOT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604071
• Other study ID #: HMP-V4
• Secondary ID: 20071801
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: April 13, 2015
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2015
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• 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

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Locations

Country	Name	City	State
United States	Charlotte Eye Ear Nose & Throat	Charlotte	North Carolina
United States	Edina Retina Consultants	Edina	Minnesota
United States	Central Florida Retina Institute	Lakeland	Florida
United States	Virginia Retina Center	Leesburg	Virginia
United States	Retina Vitreous Center	New Brunswick	New Jersey
United States	Foxman Foxman & Margolis	Northfield	New Jersey
United States	Retina care specialists	Palm Beach Gardens	Florida
United States	International Eye Center	Tampa	Florida
United States	Harkness Eye institute	W. New York	New Jersey
United States	Center for Retina & Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

United States, 

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 based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram		3 month	No
Secondary	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		3 month	No
Secondary	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		3 Month	No
Secondary	Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy		3 month	No
Secondary	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.		3 month	No
Secondary	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).		3 month	No
Secondary	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		3 month	No

External Links

•   sponsor web site