Advanced Glaucoma Progression Study

NCT01742819 | Active Not Recruiting

• 2 other identifiers: IRB# 11-0036021K23EY022659-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma; Chronic Angle Closure Glaucoma

Keywords

Glaucoma, Optical Coherence Tomography, Progression

Outcome Measures

Primary Outcomes (2)

• Visual field progression

  Worsening of the MD and/or increased visual field loss within the central 10 degrees of the field.

  5 years

• Worsening of OCT measurements

  Worsening of macular and retinal nerve fiber layer (RNFL) OCT measurements.

  5 Years

Secondary Outcomes (1)

• Contrast sensitivity

  5 years

Study Arms (1)

Advanced glaucoma

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced glaucoma patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

UCLA Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Related Publications (7)

• 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. doi: 10.1016/j.ophtha.2007.08.037. Epub 2007 Nov 12.

  PMID: 17997485 BACKGROUND

• Varma R, Ying-Lai M, Francis BA, Nguyen BB, Deneen J, Wilson MR, Azen SP; Los Angeles Latino Eye Study Group. Prevalence of open-angle glaucoma and ocular hypertension in Latinos: the Los Angeles Latino Eye Study. Ophthalmology. 2004 Aug;111(8):1439-48. doi: 10.1016/j.ophtha.2004.01.025.

  PMID: 15288969 BACKGROUND

• Curcio CA, Allen KA. Topography of ganglion cells in human retina. J Comp Neurol. 1990 Oct 1;300(1):5-25. doi: 10.1002/cne.903000103.

  PMID: 2229487 BACKGROUND

• Tan O, Chopra V, Lu AT, Schuman JS, Ishikawa H, Wollstein G, Varma R, Huang D. Detection of macular ganglion cell loss in glaucoma by Fourier-domain optical coherence tomography. Ophthalmology. 2009 Dec;116(12):2305-14.e1-2. doi: 10.1016/j.ophtha.2009.05.025. Epub 2009 Sep 10.

  PMID: 19744726 BACKGROUND

• Mori S, Hangai M, Sakamoto A, Yoshimura N. Spectral-domain optical coherence tomography measurement of macular volume for diagnosing glaucoma. J Glaucoma. 2010 Oct-Nov;19(8):528-34. doi: 10.1097/IJG.0b013e3181ca7acf.

  PMID: 20164794 BACKGROUND

• Mwanza JC, Oakley JD, Budenz DL, Chang RT, Knight OJ, Feuer WJ. Macular ganglion cell-inner plexiform layer: automated detection and thickness reproducibility with spectral domain-optical coherence tomography in glaucoma. Invest Ophthalmol Vis Sci. 2011 Oct 21;52(11):8323-9. doi: 10.1167/iovs.11-7962.

  PMID: 21917932 BACKGROUND

• Lee JW, Morales E, Sharifipour F, Amini N, Yu F, Afifi AA, Coleman AL, Caprioli J, Nouri-Mahdavi K. The relationship between central visual field sensitivity and macular ganglion cell/inner plexiform layer thickness in glaucoma. Br J Ophthalmol. 2017 Aug;101(8):1052-1058. doi: 10.1136/bjophthalmol-2016-309208. Epub 2017 Jan 11.

  PMID: 28077369 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma; Disease Progression

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kouros Nouri-Mahdavi, MD, MSc

  Jules Stein Eye Institute, UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

US (1)