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Primary Open Angle Glaucoma | Advanced Glaucoma Progression Study

Primary Open Angle Glaucoma research study

What is the primary objective of this study?

Glaucoma is one of the leading causes of blindness in the world. The key to prevention of visual loss from glaucoma is early detection of the disease or its progression and timely treatment. The proposed study will investigate the role of various tests in improving detection of disease progression in advanced glaucoma. Evaluation of the peripheral field of vision (visual field examination) remains the current standard for detection of progression in glaucoma. However, there is a lot of variability or inconsistency in eyes with advanced glaucoma, which could make it difficult to detect worsening of glaucoma with visual fields. The optic nerve demonstrates significant damage in such eyes and hence oftentimes repeat imaging of the optic nerve head is not helpful for detection of change. Therefore, imaging of the central retina (the innermost sensitive tissue lining the inside of the eye), called macula, has been proposed to supplant imaging of the nerve in eyes with severe glaucoma. The macula aids in detailed central vision. Since the macular retinal neural cells are the last ones to be affected in glaucoma, measurement of macular retinal thickness could provide significant information with regard to the course of glaucoma. In the proposed study, glaucoma patients will be tested and followed with various measurements done with newer versions of optical coherence tomography (OCT) imaging and visual field machines. The patients will undergo repeat imaging and visual field testing every 6 months over the course of 5 years. Rates of change will be estimated. We will explore if changes in various outcome measures derived from imaging are correlated with the corresponding visual field changes in glaucoma, and whether the former can be used as an alternative method for detecting simultaneous or subsequent glaucoma progression. The hypothesis for this proposed research is that macular OCT parameters are valid structural measures that can be used especially in advanced disease to follow the course of glaucoma.

Who is eligible to participate?

Inclusion Criteria: - Clinical diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, and angle closure glaucoma - Visual field MD of -6dB or worse OR visual field loss involvement at at least two points within the central 10 degrees of the field Exclusion Criteria: - Patient not within the ages of 40-80 years old - Visual acuity worse than 20/50 at baseline - Spherical refraction worse than 8D and cylindrical refraction worse than 3D - Significant retinal or neurological diseases including diabetic retinopathy or age-related macular degeneration

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Primary Open Angle Glaucoma

Pseudoexfoliative Glaucoma

Chronic Angle Closure Glaucoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Advanced glaucomaPatients with MD < -6 or visual field loss within the central 10 degrees of the visual field.

Study Status

Active, not recruiting

Start Date: May 2012

Completed Date: August 2018

Phase: N/A

Type: Observational

Design:

Primary Outcome: Visual field progression

Secondary Outcome: Contrast sensitivity

Study sponsors, principal investigator, and references

Principal Investigator: Kouros Nouri-Mahdavi, MD, MSc

Lead Sponsor: University of California, Los Angeles

Collaborator: National Eye Institute (NEI)

More information:https://clinicaltrials.gov/show/NCT01742819

McKean-Cowdin R, Wang Y, Wu J, Azen SP, Varma R; Los Angeles Latino Eye Study Group. Impact of visual field loss on health-related quality of life in glaucoma: the Los Angeles Latino Eye Study. Ophthalmology. 2008 Jun;115(6):941-948.e1. Epub 2007 Nov 12.

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