Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01010997
First received: November 8, 2009
Last updated: July 30, 2012
Last verified: July 2012

November 8, 2009
July 30, 2012
December 2009
January 2012   (final data collection date for primary outcome measure)
To investigate the FORESEE HOME ability to diagnose AMD in different stages [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010997 on ClinicalTrials.gov Archive Site
To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

AMD subjects

Age Related Macular Degeneration
Device: Foresee Home
using the Foresee home device
  • Dry AMD
    Intermediate AMD subjects
    Intervention: Device: Foresee Home
  • Wet - treated AMD
    AMD subjects under treatments
    Intervention: Device: Foresee Home
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
  • Did not perform more then 10 anti- VEGF injections
  • Age >50 years
  • VA with habitual correction >6/45 in the study eye
  • Computer users

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,
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01010997
FORESEE HOME- 02, 75909
Yes
Notal Vision Ltd
Notal Vision Ltd
Not Provided
Principal Investigator: Eliezer Kraus, MD Naharia Hospital
Notal Vision Ltd
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP