Primary Open Angle GlaucomaNCT00494923
Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma
An observational study of Primary Open Angle Glaucoma and Secondary Open Angle Glaucoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Secondary Open Angle Glaucoma, Ocular Hypertension
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1999to Dec 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Open anterior chamber angle
- Best corrected visual acuity 0.7 or better
- Age between 18 and 65 years
Who cannot join
- Any eye disease other than glaucoma
- Systemic diseases with potentially ocular involvement (e.g., diabetes mellitus)
- Myopic or hyperopic refractive error exceeding 8.0 diopters
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Eye Hospital
Erlangen, 91054
Robert Laemmer, MD, **49-9131-8533001, robert.laemmer@uk-erlangen.de
Christian Y Mardin, Prof.
About this study
Official title: Glaucoma Including Pseudoexfoliation Syndrome (SFB 539)
The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991. The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical, sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.
Read the detailed description
Purpose: Detection of onset and progression of structural and functional damage due to glaucoma. Determination of rate and amount of progressive change due to glaucoma. Characterisation of the relationship between structural and functional change over time. Evaluation of predictive factors for the development and progression of glaucoma.
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJan 1999
- Primary completionDec 2015 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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 Erlangen-Nürnberg Medical SchoolThe 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Anselm G Juenemann, Prof., Study chair, University Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494923
- Sponsor's protocol ID
- DFG-SFB539-R
- Status last verified
- Dec 2013
- First submitted
- 29 Jun 2007
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wessel JM, Horn FK, Tornow RP, Schmid M, Mardin CY, Kruse FE, Juenemann AG, Laemmer R. Longitudinal analysis of progression in glaucoma using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3613-20. doi: 10.1167/iovs.12-9786.
PubMed 23633657Hoesl LM, Tornow RP, Schrems WA, Horn FK, Mardin CY, Kruse FE, Juenemann AG, Laemmer R. Glaucoma diagnostic performance of GDxVCC and spectralis OCT on eyes with atypical retardation pattern. J Glaucoma. 2013 Apr-May;22(4):317-24. doi: 10.1097/IJG.0b013e318237c8c5.
PubMed 22027931Schrems WA, Laemmer R, Hoesl LM, Horn FK, Mardin CY, Kruse FE, Tornow RP. Influence of atypical retardation pattern on the peripapillary retinal nerve fibre distribution assessed by scanning laser polarimetry and optical coherence tomography. Br J Ophthalmol. 2011 Oct;95(10):1437-41. doi: 10.1136/bjo.2010.190074. Epub 2011 Jan 17.
PubMed 21242583Hoesl LM, Mardin CY, Horn FK, Juenemann AG, Laemmer R. Influence of glaucomatous damage and optic disc size on glaucoma detection by scanning laser tomography. J Glaucoma. 2009 Jun-Jul;18(5):385-9. doi: 10.1097/IJG.0b013e3181845ffd.
PubMed 19525729Schrems WA, Mardin CY, Horn FK, Juenemann AG, Laemmer R. Comparison of scanning laser polarimetry and optical coherence tomography in quantitative retinal nerve fiber assessment. J Glaucoma. 2010 Feb;19(2):83-94. doi: 10.1097/IJG.0b013e3181a2fc0e.
PubMed 19373100Horn FK, Mardin CY, Laemmer R, Baleanu D, Juenemann AM, Kruse FE, Tornow RP. Correlation between local glaucomatous visual field defects and loss of nerve fiber layer thickness measured with polarimetry and spectral domain OCT. Invest Ophthalmol Vis Sci. 2009 May;50(5):1971-7. doi: 10.1167/iovs.08-2405. Epub 2009 Jan 17.
PubMed 19151389Laemmer R, Schroeder S, Martus P, Viestenz A, Mardin CY. Quantification of neuroretinal rim loss using digital planimetry in long-term follow-up of normals and patients with ocular hypertension. J Glaucoma. 2007 Aug;16(5):430-6. doi: 10.1097/IJG.0b013e31804a5e80.
PubMed 17700284Laemmer R, Horn FK, Viestenz A, Juenemann AG, Mardin CY. Influence of optic disc size on parameters of retinal nerve fiber analysis with laser scanning polarimetry. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):603-8. doi: 10.1007/s00417-005-0125-1. Epub 2005 Sep 21.
PubMed 16175374Tornow RP, Schrems WA, Bendschneider D, Horn FK, Mayer M, Mardin CY, Lammer R. Atypical retardation patterns in scanning laser polarimetry are associated with low peripapillary choroidal thickness. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7523-8. doi: 10.1167/iovs.11-7557.
PubMed 21862653Horn FK, Lammer R, Mardin CY, Junemann AG, Michelson G, Lausen B, Adler W. Combined evaluation of frequency doubling technology perimetry and scanning laser ophthalmoscopy for glaucoma detection using automated classification. J Glaucoma. 2012 Jan;21(1):27-34. doi: 10.1097/IJG.0b013e3182027766.
PubMed 21173705Pasutto F, Krumbiegel M, Mardin CY, Paoli D, Lammer R, Weber BH, Kruse FE, Schlotzer-Schrehardt U, Reis A. Association of LOXL1 common sequence variants in German and Italian patients with pseudoexfoliation syndrome and pseudoexfoliation glaucoma. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1459-63. doi: 10.1167/iovs.07-1449.
PubMed 18385063Crux K, Huchzermeyer C, Kremers J, Horn FK. Objective detection of visual field defects with multifrequency VEPs. Doc Ophthalmol. 2024 Feb;148(1):15-24. doi: 10.1007/s10633-023-09949-4. Epub 2023 Sep 26.
PubMed 37749441Dussan Molinos L, Huchzermeyer C, Lammer R, Kremers J, Horn FK. Blue-Yellow VEP with Projector-Stimulation in Glaucoma. Graefes Arch Clin Exp Ophthalmol. 2022 Apr;260(4):1171-1181. doi: 10.1007/s00417-021-05473-w. Epub 2021 Nov 25.
PubMed 34821990Thiermeier N, Lammer R, Mardin C, Hohberger B. Erlanger Glaucoma Registry: Effect of a Long-Term Therapy with Statins and Acetyl Salicylic Acid on Glaucoma Conversion and Progression. Biology (Basel). 2021 Jun 16;10(6):538. doi: 10.3390/biology10060538.
PubMed 34208432Denkel L, Hohberger B, Lammer R. Influence of Mitomycin C on the Therapeutic Success of Stand-Alone Xen45 Gel Stents and Its Combination with Cataract Surgery in Open-Angle Glaucoma Patients. Klin Monbl Augenheilkd. 2021 Aug;238(8):861-867. doi: 10.1055/a-1384-1020. Epub 2021 May 17.
PubMed 34000747
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Including Pseudoexfoliation Syndrome (SFB 539)
- ClinicalTrials.gov ID
- NCT00494923
- Acronym / sponsor ID
- DFG-SFB539-R
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 1999
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Jul 2007 (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.
The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991. The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical, sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.
Detailed description
Purpose: Detection of onset and progression of structural and functional damage due to glaucoma. Determination of rate and amount of progressive change due to glaucoma. Characterisation of the relationship between structural and functional change over time. Evaluation of predictive factors for the development and progression of glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- Open anterior chamber angle
- Best corrected visual acuity 0.7 or better
- Age between 18 and 65 years
Key exclusion criteria (3 listed)
- Any eye disease other than glaucoma
- Systemic diseases with potentially ocular involvement (e.g., diabetes mellitus)
- Myopic or hyperopic refractive error exceeding 8.0 diopters
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
Time to Disease Progression
Time frame: up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
- Results publication: PubMed 23633657Wessel JM, Horn FK, Tornow RP, Schmid M, Mardin CY, Kruse FE, Juenemann AG, Laemmer R. Longitudinal analysis of progression in glaucoma using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3613-20. doi: 10.1167/iovs.12-9786.
- Results publication: PubMed 22027931Hoesl LM, Tornow RP, Schrems WA, Horn FK, Mardin CY, Kruse FE, Juenemann AG, Laemmer R. Glaucoma diagnostic performance of GDxVCC and spectralis OCT on eyes with atypical retardation pattern. J Glaucoma. 2013 Apr-May;22(4):317-24. doi: 10.1097/IJG.0b013e318237c8c5.
- Results publication: PubMed 21242583Schrems WA, Laemmer R, Hoesl LM, Horn FK, Mardin CY, Kruse FE, Tornow RP. Influence of atypical retardation pattern on the peripapillary retinal nerve fibre distribution assessed by scanning laser polarimetry and optical coherence tomography. Br J Ophthalmol. 2011 Oct;95(10):1437-41. doi: 10.1136/bjo.2010.190074. Epub 2011 Jan 17.
- Results publication: PubMed 19525729Hoesl LM, Mardin CY, Horn FK, Juenemann AG, Laemmer R. Influence of glaucomatous damage and optic disc size on glaucoma detection by scanning laser tomography. J Glaucoma. 2009 Jun-Jul;18(5):385-9. doi: 10.1097/IJG.0b013e3181845ffd.
- Results publication: PubMed 19373100Schrems WA, Mardin CY, Horn FK, Juenemann AG, Laemmer R. Comparison of scanning laser polarimetry and optical coherence tomography in quantitative retinal nerve fiber assessment. J Glaucoma. 2010 Feb;19(2):83-94. doi: 10.1097/IJG.0b013e3181a2fc0e.
- Results publication: PubMed 19151389Horn FK, Mardin CY, Laemmer R, Baleanu D, Juenemann AM, Kruse FE, Tornow RP. Correlation between local glaucomatous visual field defects and loss of nerve fiber layer thickness measured with polarimetry and spectral domain OCT. Invest Ophthalmol Vis Sci. 2009 May;50(5):1971-7. doi: 10.1167/iovs.08-2405. Epub 2009 Jan 17.
- Results publication: PubMed 17700284Laemmer R, Schroeder S, Martus P, Viestenz A, Mardin CY. Quantification of neuroretinal rim loss using digital planimetry in long-term follow-up of normals and patients with ocular hypertension. J Glaucoma. 2007 Aug;16(5):430-6. doi: 10.1097/IJG.0b013e31804a5e80.
- Results publication: PubMed 16175374Laemmer R, Horn FK, Viestenz A, Juenemann AG, Mardin CY. Influence of optic disc size on parameters of retinal nerve fiber analysis with laser scanning polarimetry. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):603-8. doi: 10.1007/s00417-005-0125-1. Epub 2005 Sep 21.
- Results publication: PubMed 21862653Tornow RP, Schrems WA, Bendschneider D, Horn FK, Mayer M, Mardin CY, Lammer R. Atypical retardation patterns in scanning laser polarimetry are associated with low peripapillary choroidal thickness. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7523-8. doi: 10.1167/iovs.11-7557.
- Results publication: PubMed 21173705Horn FK, Lammer R, Mardin CY, Junemann AG, Michelson G, Lausen B, Adler W. Combined evaluation of frequency doubling technology perimetry and scanning laser ophthalmoscopy for glaucoma detection using automated classification. J Glaucoma. 2012 Jan;21(1):27-34. doi: 10.1097/IJG.0b013e3182027766.
- Results publication: PubMed 18385063Pasutto F, Krumbiegel M, Mardin CY, Paoli D, Lammer R, Weber BH, Kruse FE, Schlotzer-Schrehardt U, Reis A. Association of LOXL1 common sequence variants in German and Italian patients with pseudoexfoliation syndrome and pseudoexfoliation glaucoma. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1459-63. doi: 10.1167/iovs.07-1449.
- Derived from this study: PubMed 37749441Crux K, Huchzermeyer C, Kremers J, Horn FK. Objective detection of visual field defects with multifrequency VEPs. Doc Ophthalmol. 2024 Feb;148(1):15-24. doi: 10.1007/s10633-023-09949-4. Epub 2023 Sep 26.
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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.
Anselm G Juenemann, Prof. study chair
University Erlangen-Nuremberg
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 Secondary Open Angle Glaucoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 3 inclusion and 3 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 12 Dec 2013. 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 Germany. 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?
Contact Anselm G Juenemann, Prof. (**49-9131-8533001, anselm.juenemann@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: up to 20 years). 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 NCT00494923, which also lists 28 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 12 Dec 2013.