Status:
COMPLETED
STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to perform exploratory analyses to evaluate rates of functional and structural change in glaucoma, to identify predictors of rapid progression in patients with glaucoma an...
Detailed Description
PRIMARY OBJECTIVES To identify and combine a set of predictors (i.e. by statistical modeling, machine learning classifiers or neural networks) to predict progression in glaucoma patients To determine...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Subjects will be eligible if the following criteria are met:
- Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past 3 years and high IOP (IOP above target), disc hemorrhage (within 3 years), family history of glaucoma-related vision loss or thin central cornea (\<510um),
- Progression is confirmed with repeatable abnormal standard automated perimetry (SAP) or progressive glaucomatous optic neuropathy
- For patients that have had previous glaucoma surgery, they can be included if they have had documented glaucomatous progression post-surgery
- Best corrected visual acuity of 20/40 or better at enrollment
- Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP \< 22mmHg
- o Normal appearing optic disc and no evidence of optic disc damage
- Ability to provide written informed consent for participation in this study
- EXCLUSION CRITERIA
- Subjects who meet any of the following criteria will be excluded from this study:
- Subjects with an ocular disease other than glaucoma
- Subjects participating in a long-term interventional clinical trial
- Subjects with any other medical condition which would prohibit them from making all study visits within the 24 months
- Glaucoma patients who have not demonstrated disease progression in the past 3 years
- Patients with diagnosis of pigmentary dispersion syndrome/glaucoma
- Patients that have had glaucoma surgery and have IOP ≤ 12 mm Hg
- Patients with advanced glaucoma with MD ≤ -20 dB
- Patients with a history of LASIK surgery
- Patients with myopia \> -6.0 diopters.
- Patients with hyperopia \>+6.0 diopters.
- In the investigator's opinion, any patient that cannot satisfactorily complete all of the structural and functional testing included in the protocol (investigator determined)
- Unable to perform reliable VF testing (Fixation losses 33% or less, false negative rate 33% or less and false positive rate of 15% or less) at the time of study entry
- In the investigator's opinion, any patient with an ocular disease that could impact study assessments
- Patients with cataracts in which surgery is planned or anticipated within the next 3 months.
- Patients with narrow angles in which laser iridotomy is planned or anticipated within the next 3 months.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2015
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01442896
Start Date
September 1 2011
End Date
December 18 2015
Last Update
January 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton Glaucoma Center, UCSD
La Jolla, California, United States, 92093