Primary Open Angle GlaucomaAGPSNCT01742819
Advanced Glaucoma Progression Study
An observational study of Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Chronic Angle Closure Glaucoma
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced glaucoma patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
About this study
Official title: Detection of Glaucoma Progression Study With Macular OCT Imaging
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.
Read the detailed description
Glaucoma is a major public health issue worldwide and manifests clinically as a chronic progressive optic neuropathy with concomitant visual field (VF) loss. Glaucoma can cause significant visual disability and decreased quality of life (1). Based on WHO's report in 2002, glaucoma is the second cause of blindness. The key to prevention of visual loss from glaucoma is early detection of the disease or its progression and timely treatment. Glaucoma can be quite advanced at the time of initial detection. The prevalence of advanced glaucoma at the time of diagnosis varies but can be quite high. For example, the average VF mean deviation (MD) in patients diagnosed with glaucoma in the Los Angeles Latino Eye Study was -9.6 dB (2), which represents moderately advanced to severe glaucoma. Detection of progression in advanced stages of glaucoma continues to be challenging. Visual field examination remains the gold standard for detection of progression in advanced glaucoma. However, long-term VF variability or noise in such eyes is significant, which could confound detection of change. The optic nerve head and peripapillary retinal nerve fiber layer (RNFL) demonstrate significant damage in such eyes and hence are not helpful for detection of change. About 50% of retinal ganglion cells (RGCs) are located within 4-5 mm of the macular center (3). Since the macular RGCs are the last ones to be affected in glaucoma, measurement of macular retinal thickness or retinal sublayers could provide significant information with regard to the course of advanced glaucoma.
The macular retinal sublayers can now be measured with reasonable accuracy with SD- OCTs. There is some evidence that measurement of the macular ganglion cell complex (GCC, combined thickness of RNFL, RGC and inner plexiform layer or IPL), or macular retinal thickness or volume may detect early glaucoma with a performance that approximates that of circumpapillary RNFL thickness measurements (4,5). In addition, such macular measurements have proved to be very reproducible (4,6). Given this excellent reproducibility, macular outcome measures would be the main candidates for following glaucoma eyes with advanced damage, in which the macular region is essentially the only retinal area with residual RGCs.
- Keywords
- Glaucoma, Optical Coherence Tomography, Progression
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced glaucoma | Patients with MD < -6 or visual field loss within the central 10 degrees of the visual field. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field progression
Worsening of the MD and/or increased visual field loss within the central 10 degrees of the field.
Measured: 5 years
Worsening of OCT measurements
Worsening of macular and retinal nerve fiber layer (RNFL) OCT measurements.
Measured: 5 Years
Secondary outcomes (1)
Contrast sensitivity
Looking at any changes in contrast sensitivity using the Vector Vision CSV-1000 eye chart.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Kouros Nouri-Mahdavi, University of California, Los Angeles
- Investigators
- Kouros Nouri-Mahdavi, MD, MSc, Principal investigator, Jules Stein Eye Institute, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742819
- Sponsor's protocol ID
- IRB# 11-003602
- Other IDs
- 1K23EY022659-01
- Acronym
- AGPS
- Status last verified
- Apr 2025
- First submitted
- 3 Dec 2012
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17997485Varma 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.
PubMed 15288969Curcio 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.
PubMed 2229487Tan 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.
PubMed 19744726Mori 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.
PubMed 20164794Mwanza 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.
PubMed 21917932Lee 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.
PubMed 28077369
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Glaucoma Progression Study With Macular OCT Imaging
- ClinicalTrials.gov ID
- NCT01742819
- Acronym / sponsor ID
- AGPS / IRB# 11-003602
- Keywords
- Glaucoma, Optical Coherence Tomography, Progression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- May 2012 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glaucoma is a major public health issue worldwide and manifests clinically as a chronic progressive optic neuropathy with concomitant visual field (VF) loss. Glaucoma can cause significant visual disability and decreased quality of life (1). Based on WHO's report in 2002, glaucoma is the second cause of blindness. The key to prevention of visual loss from glaucoma is early detection of the disease or its progression and timely treatment. Glaucoma can be quite advanced at the time of initial detection. The prevalence of advanced glaucoma at the time of diagnosis varies but can be quite high. For example, the average VF mean deviation (MD) in patients diagnosed with glaucoma in the Los Angeles Latino Eye Study was -9.6 dB (2), which represents moderately advanced to severe glaucoma. Detection of progression in advanced stages of glaucoma continues to be challenging. Visual field examination remains the gold standard for detection of progression in advanced glaucoma. However, long-term VF variability or noise in such eyes is significant, which could confound detection of change. The optic nerve head and peripapillary retinal nerve fiber layer (RNFL) demonstrate significant damage in such eyes and hence are not helpful for detection of change. About 50% of retinal ganglion cells (RGCs) are located within 4-5 mm of the macular center (3). Since the macular RGCs are the last ones to be affected in glaucoma, measurement of macular retinal thickness or retinal sublayers could provide significant information with regard to the course of advanced glaucoma.
The macular retinal sublayers can now be measured with reasonable accuracy with SD- OCTs. There is some evidence that measurement of the macular ganglion cell complex (GCC, combined thickness of RNFL, RGC and inner plexiform layer or IPL), or macular retinal thickness or volume may detect early glaucoma with a performance that approximates that of circumpapillary RNFL thickness measurements (4,5). In addition, such macular measurements have proved to be very reproducible (4,6). Given this excellent reproducibility, macular outcome measures would be the main candidates for following glaucoma eyes with advanced damage, in which the macular region is essentially the only retinal area with residual RGCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced glaucoma | – | –Patients with MD < -6 or visual field loss within the central 10 degrees of the visual field. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced glaucoma patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual field progression
Time frame: 5 years
Worsening of the MD and/or increased visual field loss within the central 10 degrees of the field.
Worsening of OCT measurements
Time frame: 5 Years
Worsening of macular and retinal nerve fiber layer (RNFL) OCT measurements.
1 secondary outcome
Contrast sensitivity
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 17997485McKean-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.
- Background: PubMed 15288969Varma 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.
- Background: PubMed 2229487Curcio 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.
- Background: PubMed 19744726Tan 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.
- Background: PubMed 20164794Mori 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.
- Background: PubMed 21917932Mwanza 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.
- Derived from this study: PubMed 28077369Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kouros Nouri-Mahdavi, MD, MSc principal investigator
Jules Stein Eye Institute, UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field progression (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742819, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.