Age-Related Macular Degeneration (AMD) - Usability Study

Age Related Macular Degeneration Clinical Trial

— AMD  

Official title:

Age-Related Macular Degeneration (AMD) - Usability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963339
• Other study ID #: US02
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: September 22, 2010
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

Description:

The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion criteria

• Subjects diagnosed as intermediate AMD in at least one eye

• Visual Acuity (VA) with habitual correction <20/60 in the study eye

• Qualified in the clinic to use the device

• Ability to speak, read and understand instructions in English

• Subjects with ability to comprehend and sign the informed consent/authorization

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
Home Monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful unpacking and installation		3 months	No
Primary	Successful self tutorial performance		3 months	No
Primary	Ability of the subjects to operate the device as define by a successful test completion		3 months	No
Secondary	Evaluate the success rate of the interactive tutorial as defined by a reliable test result.		3 month	No