NCT00926913

Brief Summary

With the aging of the population, the prevalence of age-related macular degeneration (AMD) eye disease has resulted in a large number of people suffering from central vision loss. In fact, the most prevalent cause of blindness among veterans is AMD. Since the number of elderly veterans is expected to double in the next 10 years, loss of vision due to AMD is also expected to proportionally and considerably escalate. People with impaired vision have difficulty with daily activities, such as, reading, driving, and recognizing faces. The goal of the research project is to provide information on factors that contribute to visual impairment. This knowledge is necessary for the development of innovative approaches that will optimize the benefit of vision rehabilitation techniques, aimed at improving vision, thus allowing our veterans to maintain function and productivity. The findings from the proposed research will benefit our veterans and all aging people.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
5.4 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

June 22, 2009

Last Update Submit

April 3, 2015

Conditions

Keywords

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Ocular aberrations

    One time only

Study Arms (1)

Group 1

Eligibility Criteria

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

Normal healthy subjects and patients diagnosed with age-related macular degeneration and central vision loss will participate in the study.

You may qualify if:

  • qualification for entry into the study based on clinical evaluation,
  • competence to understand and willingness to sign an informed consent form and participate in the study,
  • pupils that dilate to 5 mm or more.
  • corrected visual acuities better than 20/30,
  • intraocular pressure less than 21 mm Hg,
  • no family history of AMD,
  • no history of ophthalmic surgery or neurologic disease,
  • no history of diabetes, glaucoma, or a history of elevated intraocular pressure.
  • The recruitment will ensure that approximately 40 subjects will fall into each of the three age groups, 50 to 60 years, 61 to 70 years, and 71 years and older. One eye of each subject will be selected at random to be included in the study.

You may not qualify if:

  • Ocular opacities that preclude acquiring a clear fundus photograph or refractive errors greater than 4 diopters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Mahnaz Shahidi, PhD

    Jesse Brown VA Medical Center, Chicago, IL

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations