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
  Purpose

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.


Condition Intervention
Age Related Macular Degeneration
Device: Foresee Home

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • To investigate the FORESEE HOME ability to diagnose AMD in different stages [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dry AMD
Intermediate AMD subjects
Device: Foresee Home
using the Foresee home device
Wet - treated AMD
AMD subjects under treatments
Device: Foresee Home
using the Foresee home device

Detailed Description:

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.

  Eligibility

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

AMD subjects

Criteria

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
  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: NCT01010997

Locations
Israel
Naharia Hospital
Naharia, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Eliezer Kraus, MD Naharia Hospital
  More Information

No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01010997     History of Changes
Other Study ID Numbers: FORESEE HOME- 02, 75909
Study First Received: November 8, 2009
Last Updated: July 30, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:
AMD, CNV

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

ClinicalTrials.gov processed this record on July 29, 2014