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

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00776451
First received: October 20, 2008
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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.


Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients

Resource links provided by NLM:


Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • The proportion of subjects who successfully completed the test by themselves, in a home simulated environment [ Time Frame: 2 clinic visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects diagnosed with Dry AMD

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dry AMD subjects

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776451

Locations
Israel
Belinson Medical Center
Petach Tikva, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Neil Bressler, Prof. JHMC
  More Information

Additional Information:
No publications provided

Responsible Party: Osnat Ehrman, Notal Vision
ClinicalTrials.gov Identifier: NCT00776451     History of Changes
Other Study ID Numbers: PHP-US-01
Study First Received: October 20, 2008
Last Updated: June 2, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:
AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014