Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

Age Related Macular Degeneration Clinical Trial

— Foresee Home  

Official title:

Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010997
• Other study ID #: FORESEE HOME- 02
• Secondary ID: 75909
• Status: Completed
• Phase: N/A
• First received: November 8, 2009
• Last updated: July 30, 2012
• Start date: December 2009
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• Foresee Home
using the Foresee home device

Locations

Country	Name	City	State
Israel	Naharia Hospital	Naharia

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the FORESEE HOME ability to diagnose AMD in different stages		1 year	No
Secondary	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	No