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Glaucoma
+2

Development and Validation of a Model to Predict Fast Progression in Glaucoma

Sponsored by Duke University

About this trial

Last updated a year ago

Study ID

Pro00105990

Status

Terminated

Type

Observational

Placebo

No

Accepting

18-75 Years
40 to 90 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

1. The purpose of this study is to obtain genetic data on a well-defined population of patients with glaucoma that had accurate measurements of rates of structural and functional change over time. 2. The investigators aim to recruit 5,000 patients for Phase I and 100 patients for Phase II over a period of 2 years for obtaining blood samples which will be processed for extraction of DNA and genotyping. Phase II also includes eye examination. Patients will be selected from the Duke Glaucoma Registry (DGR) database and will be contacted by phone, mail or email using a standardized script and procedure. 3. Data analysis, based on patient-blind (no personal health information) data will take place at Duke and Genentech. No protected health information (PHI) will leave Duke. Standard statistical methods will be used to analyze the collected data and to develop predictive statistical models for fast progression in glaucoma. Risks from participating in the study are low and include loss of confidentiality and inherent issues related to drawing blood.

What are the Participation Requirements?

Phase I:

Inclusion Criteria:

1. Subjects will be identified from a previous database search (PRO00103899) with
glaucoma or suspicion of glaucoma based on International Classification of Diseases
(ICD) codes at baseline.

Phase II:

Inclusion criteria:

1. Subjects must be between the ages of 40 and 90 years old;

2. Both males and females will be included.

3. Be able and willing to provide signed informed consent and follow study instructions

Exclusion criteria:

1. Subjects will be excluded if they present with any systemic or ocular conditions
that in the opinion of the Principal Investigator may prevent them from completing
the tests (e.g. history of seizures or pathologies affecting the vestibular system
or lower limbs).

2. Women of child-bearing potential will be excluded from tests that require pupil
dilation, unless they have already received dilating drops as part of their standard
of care.

Locations

Location

Status