Sensitivity of the Home Macular Perimeter (HMP) - Full Text View

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00604071

Purpose

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

Condition
Age Related Macular Degeneration Choroidal Neovascularization

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV

Detailed 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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

62 completed subjects with new choroidal neovascularization AMD in at least one eye

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604071

Contacts

Contact: Osnat Ms Ehrman, MSc

972-3-6293763 ext 117

osnat@notalvision.com

Locations

United States, Florida
Central Florida Retina Institute	Recruiting
Lakeland, Florida, United States, 33805
Contact: Scott Friedman, MD
Principal Investigator: Scott Friedman, MD
Center for Retina & Macular Disease	Recruiting
Winter Haven, Florida, United States, 33880
Contact: Michael Tolentino, MD
Principal Investigator: Michael Tolentino, MD
Retina care specialists	Recruiting
Palm Beach Gardens, Florida, United States, 33410
Contact: Mark Michels, MD
Principal Investigator: Mark Michels, MD
International Eye Center	Not yet recruiting
Tampa, Florida, United States, 33603
Contact: Don Perez, MD
Principal Investigator: Don Perez, MD
United States, Minnesota
Edina Retina Consultants	Recruiting
Edina, Minnesota, United States, 55435
Contact: Richard Johnston, MD
Principal Investigator: Richard Johnston, MD
United States, New Jersey
Retina Vitreous Center	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Daniel Roth, MD
Principal Investigator: Daniel Roth, MD
Foxman Foxman & Margolis	Recruiting
Northfield, New Jersey, United States, 08225
Contact: Guri Bronner, MD
Principal Investigator: Guri Bronner, MD
Harkness Eye institute	Not yet recruiting
W. New York, New Jersey, United States, 10032
Contact: Howard Fine, MD
Principal Investigator: Howard Fine, MD
United States, North Carolina
Charlotte Eye Ear Nose & Throat	Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Justin Brown, MD
Principal Investigator: Justin Brown, MD
United States, Virginia
Virginia Retina Center	Recruiting
Leesburg, Virginia, United States, 20176
Contact: Sam Mansour, MD
Principal Investigator: Sam Mansour, MD

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Principal Investigator:

Neil Bressler, Prof.

JHMC

More Information

sponsor web site This link exits the ClinicalTrials.gov site

Responsible Party:	Notal Vision ( Osnat Ehrman )
Study ID Numbers:	HMP-V4, 20071801
Study First Received:	January 10, 2008
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00604071
Health Authority:	United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:

HMP, CNV, PHP, HPHP, AMD

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Neoplasm Metastasis
Retinal Degeneration
Macular Degeneration

Neovascularization, Pathologic
Congenital Abnormalities
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009