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Sensitivity of the Home Macular Perimeter (HMP)

Information source: Notal Vision Ltd
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age Related Macular Degeneration; Choroidal Neovascularization

Phase: N/A

Status: Completed

Sponsored by: Notal Vision Ltd

Official(s) and/or principal investigator(s):
Neil Bressler, Prof., Principal Investigator, Affiliation: JHMC

Summary

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

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

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

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

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.

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).

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

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Central Florida Retina Institute, Lakeland, Florida 33805, United States

Retina care specialists, Palm Beach Gardens, Florida 33410, United States

International Eye Center, Tampa, Florida 33603, United States

Center for Retina & Macular Disease, Winter Haven, Florida 33880, United States

Edina Retina Consultants, Edina, Minnesota 55435, United States

Retina Vitreous Center, New Brunswick, New Jersey 08901, United States

Foxman Foxman & Margolis, Northfield, New Jersey 08225, United States

Harkness Eye institute, W. New York, New Jersey 10032, United States

Charlotte Eye Ear Nose & Throat, Charlotte, North Carolina 28210, United States

Virginia Retina Center, Leesburg, Virginia 20176, United States

Additional Information

sponsor web site

Starting date: November 2007
Last updated: April 13, 2015

Page last updated: August 20, 2015

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