NCT00592826

Brief Summary

The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

January 1, 2008

Last Update Submit

April 13, 2015

Conditions

Age Related Macular Degeneration

Keywords

PHPHMPHPHPAMDCNV

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects who successfully set up the device

    1 month

  • Proportion of subjects who successfully pass the training program (successful calibration module)

    1 month

Secondary Outcomes (1)

  • Proportion of subjects with reliable tests results

    1 month

Eligibility Criteria

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

Subjects will be recruited in community centers and clinics and will include up to 25 people aged \>50 years (Age-related Macular Degeneration age group). The group will be heterogeneous in terms of education, age, ethnic background, and gender. The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study

You may qualify if:

  • Age \>50 years
  • Familiar with computer usage
  • Capable and willing to sign a consent form and participate in the study
  • Ability to speak, read and understand instructions in English

You may not qualify if:

  • Subject already participating in another study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Adam Mr Weinstein, MD

    Kidney Health Center of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 14, 2008

Study Start

November 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 14, 2015

Record last verified: 2015-04