NCT01010997

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

2.1 years

First QC Date

November 8, 2009

Last Update Submit

July 30, 2012

Conditions

Age Related Macular Degeneration

Keywords

AMD, CNV

Outcome Measures

Primary Outcomes (1)

  • To investigate the FORESEE HOME ability to diagnose AMD in different stages

    1 year

Secondary Outcomes (1)

  • 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).

    1 year

Study Arms (2)

Dry AMD

Intermediate AMD subjects

Device: Foresee Home

Wet - treated AMD

AMD subjects under treatments

Device: Foresee Home

Interventions

Foresee HomeDEVICE

using the Foresee home device

Dry AMDWet - treated AMD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AMD subjects

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naharia Hospital

Nahariya, Israel

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eliezer Kraus, MD

    Naharia Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2009

First Posted

November 10, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

IL(1)