Primary Open Angle GlaucomaADAGESNCT00221923
African Descent and Glaucoma Evaluation Study
An observational study of Primary Open Angle Glaucoma, run by University of California, San Diego at 3 sites in United States.
Trial summary
According to the National Eye Institute, Glaucoma affects about three million Americans. Among Blacks in the United States, open- angle glaucoma is the leading cause of irreversible visual loss. Glaucoma is four times more likely to develop in Blacks than in Whites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 1,540 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2002to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults of African or European descent based on self-report.
Who may be able to join
- Open angles
- Best-corrected acuity of 20/40 or better
- Spherical refraction within + 5.0 D, and cylinder within + 3.0 D with plus OR minus cylinders
- ≥ 18 years old
- A family history of glaucoma is allowed
- Ability to obtain adequate or better quality stereophotographs
- Ability to do reliable standard Humphrey 30-2 or 24-2 visual fields
- Participants with glaucoma or at risk for glaucoma or healthy controls
Who cannot join
- History of intraocular surgery (except uncomplicated cataract or glaucoma surgery)
- Problems other than Glaucoma affecting color vision
- Non glaucomatous secondary causes of elevated IOP ( e.g. iridocyclitis, trauma)
- Other intraocular eye disease
- Other diseases affecting visual field (e:g pituitary lesions, demyelinating diseases, HIV+ or AIDS, or diabetic retinopathy) with medications known to affect visual field sensitivity
- Problems other than Glaucoma affecting color vision
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama-Callahan Eye Foundation, Prof. Bldg.
Birmingham, Alabama, 35233
UCSD Hamilton Glaucoma Center
La Jolla, California, 92093-0946
New York Eye & Ear Infirmary
New York, New York, 10003
About this study
Official title: African Descent and Glaucoma Evaluation Study (Formerly African Americans With Glaucoma Study)
According to the National Eye Institute, Glaucoma affects about three million Americans. Among Blacks in the United States, open- angle glaucoma is the leading cause of irreversible visual loss. Glaucoma is four times more likely to develop in Blacks than in Whites.
This is a prospective longitudinal, multi- site observational cohort study designed to obtain visual function and optic nerve structure data on eyes of Black and White Americans. The investigators will evaluate the relationship between changes in the structure of the eye and the vision loss caused by glaucoma.This is the first study where both populations are matched for quality of care and equal access to care.
Read the detailed description
The purpose of the study is:
- To further determine the nature of vision loss and optic nerve structural change associated with glaucoma. Using recently developed measures of visual function and techniques for imaging the eye, we will use a multivariate approach for analysis of the functional and structural changes associated with glaucoma to delineate further the relationship of these changes to the underlying physiological mechanisms..
- To evaluate and improve new diagnostic and monitoring techniques encompassing measures of visual function and optic nerve and retina nerve fiber layer structure and to compare the rate and patterns of progression of glaucomatous damage in Black and White eyes.
- To improve techniques for evaluation of current management and new therapies for glaucoma as they become available. We will expand our analysis using multivariate techniques incorporating visual function, optic nerve structure, and various risk factors to improve detection of true change. We will determine whether the benefits found in Whites using visual function specific perimetry and optic disc imaging for earlier detection and for monitoring progression are also found for Blacks.
- To determine the quantitative temporal relationships between recognizable optic nerve damage and measurable visual field loss and how these relationships differ among Black and White patients. Using new techniques with improved sensitivity, the detection and monitoring of early optic disc defects may provide profiles of people at risk for developing glaucomatous visual function loss thus better defining target populations for treatment.
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary open angle glaucoma, African American, Glaucoma/pathology, Glaucoma/ physiopathology, Nerve Fibers/pathology, Risk factor glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
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 |
|---|---|---|
| Healthy individuals | They will be considered if they are above 30 years old. There is no upper age limit. Subject can be either male or female, and from African or European Descent. They must speak, read, and understand English. They can be diagnosed with other health disorders. | |
| Persons at risk for or with primary open angle glaucoma | They will be considered if they are above 30 years old. There is no upper age limit. Subject can be either male or female, and from African or European Descent. They must speak, read, and understand English. They can be diagnosed with other health disorders. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionJan 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- 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
- 1,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Linda Zangwill, University of California, San Diego
- Investigators
- Linda M Zangwill, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221923
- Sponsor's protocol ID
- NEI U10 EY 14267
- Other IDs
- R01EY023704, R01EY026574
- Acronym
- ADAGES
- Status last verified
- Jul 2021
- First submitted
- 14 Sep 2005
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sample PA, Bosworth CF, Blumenthal EZ, Girkin C, Weinreb RN. Visual function-specific perimetry for indirect comparison of different ganglion cell populations in glaucoma. Invest Ophthalmol Vis Sci. 2000 Jun;41(7):1783-90.
PubMed 10845599Racette L, Boden C, Kleinhandler SL, Girkin CA, Liebmann JM, Zangwill LM, Medeiros FA, Bowd C, Weinreb RN, Wilson MR, Sample PA. Differences in visual function and optic nerve structure between healthy eyes of blacks and whites. Arch Ophthalmol. 2005 Nov;123(11):1547-53. doi: 10.1001/archopht.123.11.1547.
PubMed 16286617Bathija R, Zangwill L, Berry CC, Sample PA, Weinreb RN. Detection of early glaucomatous structural damage with confocal scanning laser tomography. J Glaucoma. 1998 Apr;7(2):121-7.
PubMed 9559499Zangwill L, Knauer S, Williams JM, Weinreb RN, Retinal fiber layer assessment by scanning laser polarimetery, optical coherence tomography and retinal nerve fiber layer photography. In: Lemij HG, Schuman JS, eds. The Shape of Glaucoma, Quantitative Neural Imaging Techniques. The Hague Kugler Publications, 2000:239-252
Wilson MR. Glaucoma in blacks: where do we go from here? JAMA. 1989 Jan 13;261(2):281-2. No abstract available.
PubMed 2909027Munoz B, West SK, Rubin GS, Schein OD, Quigley HA, Bressler SB, Bandeen-Roche K. Causes of blindness and visual impairment in a population of older Americans: The Salisbury Eye Evaluation Study. Arch Ophthalmol. 2000 Jun;118(6):819-25. doi: 10.1001/archopht.118.6.819.
PubMed 10865321Tielsch JM, Sommer A, Katz J, Royall RM, Quigley HA, Javitt J. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA. 1991 Jul 17;266(3):369-74.
PubMed 2056646Javitt JC, McBean AM, Nicholson GA, Babish JD, Warren JL, Krakauer H. Undertreatment of glaucoma among black Americans. N Engl J Med. 1991 Nov 14;325(20):1418-22. doi: 10.1056/NEJM199111143252005.
PubMed 1922253Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. doi: 10.1016/0039-6257(86)90051-2.
PubMed 3529468Sample PA, Weinreb RN. Color perimetry for assessment of primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1869-75.
PubMed 2211033Sample PA, Madrid ME, Weinreb RN. Evidence for a variety of functional defects in glaucoma-suspect eyes. J Glaucoma. 1994 Summer;3 Suppl 1:S5-18.
PubMed 19920588Sample PA, Johnson CA, Haegerstrom-Portnoy G, Adams AJ. Optimum parameters for short-wavelength automated perimetry. J Glaucoma. 1996 Dec;5(6):375-83.
PubMed 8946293Yamagishi N, Anton A, Sample PA, Zangwill L, Lopez A, Weinreb RN. Mapping structural damage of the optic disk to visual field defect in glaucoma. Am J Ophthalmol. 1997 May;123(5):667-76. doi: 10.1016/s0002-9394(14)71079-7.
PubMed 9152072Anton A, Yamagishi N, Zangwill L, Sample PA, Weinreb RN. Mapping structural to functional damage in glaucoma with standard automated perimetry and confocal scanning laser ophthalmoscopy. Am J Ophthalmol. 1998 Apr;125(4):436-46. doi: 10.1016/s0002-9394(99)80183-4.
PubMed 9559728Girkin CA, Emdadi A, Sample PA, Blumenthal EZ, Lee AC, Zangwill LM, Weinreb RN. Short-wavelength automated perimetry and standard perimetry in the detection of progressive optic disc cupping. Arch Ophthalmol. 2000 Sep;118(9):1231-6. doi: 10.1001/archopht.118.9.1231.
PubMed 10980768
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African Descent and Glaucoma Evaluation Study (Formerly African Americans With Glaucoma Study)
- ClinicalTrials.gov ID
- NCT00221923
- Acronym / sponsor ID
- ADAGES / NEI U10 EY 14267
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary open angle glaucoma, African American, Glaucoma/pathology, Glaucoma/ physiopathology, Nerve Fibers/pathology, Risk factor glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,540 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Sep 2002 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 22 Sep 2005 (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.
According to the National Eye Institute, Glaucoma affects about three million Americans. Among Blacks in the United States, open- angle glaucoma is the leading cause of irreversible visual loss. Glaucoma is four times more likely to develop in Blacks than in Whites.
This is a prospective longitudinal, multi- site observational cohort study designed to obtain visual function and optic nerve structure data on eyes of Black and White Americans. The investigators will evaluate the relationship between changes in the structure of the eye and the vision loss caused by glaucoma.This is the first study where both populations are matched for quality of care and equal access to care.
Detailed description
The purpose of the study is:
- To further determine the nature of vision loss and optic nerve structural change associated with glaucoma. Using recently developed measures of visual function and techniques for imaging the eye, we will use a multivariate approach for analysis of the functional and structural changes associated with glaucoma to delineate further the relationship of these changes to the underlying physiological mechanisms..
- To evaluate and improve new diagnostic and monitoring techniques encompassing measures of visual function and optic nerve and retina nerve fiber layer structure and to compare the rate and patterns of progression of glaucomatous damage in Black and White eyes.
- To improve techniques for evaluation of current management and new therapies for glaucoma as they become available. We will expand our analysis using multivariate techniques incorporating visual function, optic nerve structure, and various risk factors to improve detection of true change. We will determine whether the benefits found in Whites using visual function specific perimetry and optic disc imaging for earlier detection and for monitoring progression are also found for Blacks.
- To determine the quantitative temporal relationships between recognizable optic nerve damage and measurable visual field loss and how these relationships differ among Black and White patients. Using new techniques with improved sensitivity, the detection and monitoring of early optic disc defects may provide profiles of people at risk for developing glaucomatous visual function loss thus better defining target populations for treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –They will be considered if they are above 30 years old. There is no upper age limit. Subject can be either male or female, and from African or European Descent. They must speak, read, and understand English. They can be diagnosed with other health disorders. |
| Persons at risk for or with primary open angle glaucoma | – | –They will be considered if they are above 30 years old. There is no upper age limit. Subject can be either male or female, and from African or European Descent. They must speak, read, and understand English. They can be diagnosed with other health disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults of African or European descent based on self-report.
Key inclusion criteria (8 listed)
- Open angles
- Best-corrected acuity of 20/40 or better
- Spherical refraction within + 5.0 D, and cylinder within + 3.0 D with plus OR minus cylinders
- ≥ 18 years old
- A family history of glaucoma is allowed
Key exclusion criteria (6 listed)
- History of intraocular surgery (except uncomplicated cataract or glaucoma surgery)
- Problems other than Glaucoma affecting color vision
- Non glaucomatous secondary causes of elevated IOP ( e.g. iridocyclitis, trauma)
- Other intraocular eye disease
- Other diseases affecting visual field (e:g pituitary lesions, demyelinating diseases, HIV+ or AIDS, or diabetic retinopathy) with medications known to affect visual field sensitivity
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Background: PubMed 10845599Sample PA, Bosworth CF, Blumenthal EZ, Girkin C, Weinreb RN. Visual function-specific perimetry for indirect comparison of different ganglion cell populations in glaucoma. Invest Ophthalmol Vis Sci. 2000 Jun;41(7):1783-90.
- Background: PubMed 16286617Racette L, Boden C, Kleinhandler SL, Girkin CA, Liebmann JM, Zangwill LM, Medeiros FA, Bowd C, Weinreb RN, Wilson MR, Sample PA. Differences in visual function and optic nerve structure between healthy eyes of blacks and whites. Arch Ophthalmol. 2005 Nov;123(11):1547-53. doi: 10.1001/archopht.123.11.1547.
- Background: PubMed 9559499Bathija R, Zangwill L, Berry CC, Sample PA, Weinreb RN. Detection of early glaucomatous structural damage with confocal scanning laser tomography. J Glaucoma. 1998 Apr;7(2):121-7.
- BackgroundZangwill L, Knauer S, Williams JM, Weinreb RN, Retinal fiber layer assessment by scanning laser polarimetery, optical coherence tomography and retinal nerve fiber layer photography. In: Lemij HG, Schuman JS, eds. The Shape of Glaucoma, Quantitative Neural Imaging Techniques. The Hague Kugler Publications, 2000:239-252
- Background: PubMed 2909027Wilson MR. Glaucoma in blacks: where do we go from here? JAMA. 1989 Jan 13;261(2):281-2. No abstract available.
- Background: PubMed 10865321Munoz B, West SK, Rubin GS, Schein OD, Quigley HA, Bressler SB, Bandeen-Roche K. Causes of blindness and visual impairment in a population of older Americans: The Salisbury Eye Evaluation Study. Arch Ophthalmol. 2000 Jun;118(6):819-25. doi: 10.1001/archopht.118.6.819.
- Background: PubMed 2056646Tielsch JM, Sommer A, Katz J, Royall RM, Quigley HA, Javitt J. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA. 1991 Jul 17;266(3):369-74.
- Background: PubMed 1922253Javitt JC, McBean AM, Nicholson GA, Babish JD, Warren JL, Krakauer H. Undertreatment of glaucoma among black Americans. N Engl J Med. 1991 Nov 14;325(20):1418-22. doi: 10.1056/NEJM199111143252005.
- Background: PubMed 3529468Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. doi: 10.1016/0039-6257(86)90051-2.
- Background: PubMed 2211033Sample PA, Weinreb RN. Color perimetry for assessment of primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1869-75.
- Background: PubMed 19920588Sample PA, Madrid ME, Weinreb RN. Evidence for a variety of functional defects in glaucoma-suspect eyes. J Glaucoma. 1994 Summer;3 Suppl 1:S5-18.
- Background: PubMed 8946293Sample PA, Johnson CA, Haegerstrom-Portnoy G, Adams AJ. Optimum parameters for short-wavelength automated perimetry. J Glaucoma. 1996 Dec;5(6):375-83.
- Website at UCSDLink provided by the sponsor.
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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.
Linda M Zangwill, Ph.D. principal investigator
University of California, San Diego
3 sites 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, run by University of California, San Diego at 3 sites 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221923, which also lists 48 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 6 Jul 2021.