Sensitivity of the Home Macular Perimeter (HMP)

NCT ID: NCT00604071

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Age Related Macular Degeneration Choroidal Neovascularization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Notal Vision Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Bressler, Prof.

Role: PRINCIPAL_INVESTIGATOR

JHMC

Locations

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Central Florida Retina Institute

Lakeland, Florida, United States

Site Status

Retina care specialists

Palm Beach Gardens, Florida, United States

Site Status

International Eye Center

Tampa, Florida, United States

Site Status

Center for Retina & Macular Disease

Winter Haven, Florida, United States

Site Status

Edina Retina Consultants

Edina, Minnesota, United States

Site Status

Retina Vitreous Center

New Brunswick, New Jersey, United States

Site Status

Foxman Foxman & Margolis

Northfield, New Jersey, United States

Site Status

Harkness Eye institute

West New York, New Jersey, United States

Site Status

Charlotte Eye Ear Nose & Throat

Charlotte, North Carolina, United States

Site Status

Virginia Retina Center

Leesburg, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20071801

Identifier Type: -

Identifier Source: secondary_id

HMP-V4

Identifier Type: -

Identifier Source: org_study_id

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