NCT00596388

Brief Summary

Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 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

January 7, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

4.8 years

First QC Date

January 7, 2008

Last Update Submit

May 14, 2013

Conditions

Age Related Macular Degeneration

Keywords

HMP, AMD, CNV, PHP, HPHP

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who manage to use the device as in a daily testing

    6 month

Study Arms (1)

1

Subjects diagnosed as intermediate AMD

Eligibility Criteria

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

• Subjects diagnosed as intermediate AMD

You may qualify if:

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed as intermediate AMD in at least one eye
  • Age \>50 years
  • VA with habitual correction \>20/60 in the study eye
  • Ability to speak, read and understand instructions in Hebrew
  • Familiar with computer usage

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, CFP.
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  • Patients diagnosed with geographic atrophy (GA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical center

Afula, Israel

Location

Related Links

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yaron Mr Lang, MD

    Haemek 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

January 7, 2008

First Posted

January 17, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

IL(1)