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OpenTrials
Completed

NCT Number: NCT00776451

Usability of the PreView PHP for Home Use in Intermediate AMD Patients

To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

Completed

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Belinson Medical Center

Petah Tikva, Israel

About this study

The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.

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 diagnosed as intermediate AMD in at least one eye
  • Age ≥65 years
  • VA with habitual correction better than 20/60 in the study eye
  • Ability to speak, read and understand instructions in English or Hebrew
  • Qualified to use the device by health care professional

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.
  • Any non-macular related ocular surgery or macular surgery performed within 3 months prior to study entry in the target eye
  • Participation in another study with the exclusion of AREDS study
  • Patients diagnosed with geographic atrophy (GA)

Treatment and study plan

Primary outcomes

  1. The proportion of subjects who successfully completed the test by themselves, in a home simulated environment

    Time frame: 2 clinic visits

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study title

Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2008
Registry last updated
Jun 3, 2009

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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