STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk

Completed

Conditions studied: Primary Open Angle Glaucoma

In brief

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 and to identify possible genetic factors and biomarkers associated with the disease.

Key facts

Study ID

NCT01442896

Run by

University of California, San Diego

People needed

133

Starts

2011-09-01

Expected to finish

2015-12-18

Last updated by the study team

2024-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hamilton Glaucoma Center, UCSD — La Jolla, California, United States

Full record on ClinicalTrials.gov

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