Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients - Full Text View

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00748384

Purpose

The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Condition
Age Related Macular Degeneration

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:

Proportion of subjects who managed to set the device [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Number of device malfunctions [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Average use of the device [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Self trained subjects
2 supervised trained subjects

Detailed Description:

Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects diagnosed as Intermediate AMD

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 (in case a patient will convert during the study period he will be excluded)
- Age more than 50 years
- VA with habitual correction better than 20/60 in the study eye
- Ability to speak, read and understand instructions in English or Hebrew
- 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.
- Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
- Never been tested on the PHP device
- Participation in another study with the exclusion of AREDS study
- Patients diagnosed with geographic atrophy (GA)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748384

Contacts

Contact: Osnat Ehrman, M.Sc.

+972 3 6293763 ext 117

osnat@notalvision.com

Locations

Israel
Kaplan Medical Center
Rechovot, Israel
Meir Medical Center
Kfar Saba, Israel

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Principal Investigator:

Haya Morori Katz, M.D.

Kaplan Medical Center

More Information

sponsor site This link exits the ClinicalTrials.gov site

Responsible Party:	Notal Vision LTD ( Osnat Ehrman )
Study ID Numbers:	HMP-UU2
Study First Received:	September 4, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00748384
Health Authority:	Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:

HMP, CNV, AMD, PHP, HPHP, foresee

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009