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Completed

NCT Number: NCT00604071

Sensitivity of the Home Macular Perimeter (HMP)

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

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Key information

Conditions

Age Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Florida Retina Institute, Lakeland, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study 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

Acronym: HMP

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2008
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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