Clinical trial NCT00494923: Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma
Official title: Glaucoma Including Pseudoexfoliation Syndrome (SFB 539)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Secondary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-07-02
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief 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. 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.

Eligibility criteria: Participants:

* Patients: Primary open angle glaucoma, secondary open angle glaucoma due to PEX or MDS, glaucoma suspects including ocular hypertension
* Healthy volunteers (for cross sectional analysis only)

Inclusion Criteria:

* Open anterior chamber angle
* Best corrected visual acuity 0.7 or better
* Age between 18 and 65 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to Disease Progression
timeFrame: up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Eye Hospital
Study officials:
affiliation: University Erlangen-Nuremberg
name: Anselm G Juenemann, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: Hoesl 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.
citation: Schrems 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.
citation: Hoesl 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.
citation: Schrems 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.
citation: Horn 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.
citation: Laemmer 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.
citation: Laemmer 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.
citation: Tornow 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.
citation: Horn 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.
citation: Pasutto 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.
citation: Dussan 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.
citation: Thiermeier 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.
citation: Denkel 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.
citation: Hohberger B, Lucio M, Schlick S, Wollborn A, Hosari S, Mardin C. OCT-angiography: Regional reduced macula microcirculation in ocular hypertensive and pre-perimetric glaucoma patients. PLoS One. 2021 Feb 11;16(2):e0246469. doi: 10.1371/journal.pone.0246469. eCollection 2021.
citation: Tornow RP, Kolar R, Odstrcilik J, Labounkova I, Horn F. Imaging video plethysmography shows reduced signal amplitude in glaucoma patients in the area of the microvascular tissue of the optic nerve head. Graefes Arch Clin Exp Ophthalmol. 2021 Feb;259(2):483-494. doi: 10.1007/s00417-020-04934-y. Epub 2020 Sep 22.
citation: Hohberger B, Kunze R, Wallukat G, Kara K, Mardin CY, Lammer R, Schlotzer-Schrehardt U, Hosari S, Horn F, Munoz L, Herrmann M. Autoantibodies Activating the beta2-Adrenergic Receptor Characterize Patients With Primary and Secondary Glaucoma. Front Immunol. 2019 Oct 1;10:2112. doi: 10.3389/fimmu.2019.02112. eCollection 2019.
citation: Edlinger FSM, Schrems-Hoesl LM, Mardin CY, Laemmer R, Kruse FE, Schrems WA. Structural changes of macular inner retinal layers in early normal-tension and high-tension glaucoma by spectral-domain optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2018 Jul;256(7):1245-1256. doi: 10.1007/s00417-018-3944-6. Epub 2018 Mar 9.
citation: Junemann A, Hohberger B, Rech J, Sheriff A, Fu Q, Schlotzer-Schrehardt U, Voll RE, Bartel S, Kalbacher H, Hoebeke J, Rejdak R, Horn F, Wallukat G, Kunze R, Herrmann M. Agonistic Autoantibodies to the beta2-Adrenergic Receptor Involved in the Pathogenesis of Open-Angle Glaucoma. Front Immunol. 2018 Feb 12;9:145. doi: 10.3389/fimmu.2018.00145. eCollection 2018.
citation: Schrems-Hoesl LM, Schrems WA, Laemmer R, Kruse FE, Mardin CY. Precision of Optic Nerve Head and Retinal Nerve Fiber Layer Parameter Measurements by Spectral-domain Optical Coherence Tomography. J Glaucoma. 2018 May;27(5):407-414. doi: 10.1097/IJG.0000000000000875.
citation: Diekmann T, Schrems-Hoesl LM, Mardin CY, Laemmer R, Horn FK, Kruse FE, Schrems WA. Predictive Factors for Visual Field Conversion: Comparison of Scanning Laser Polarimetry and Optical Coherence Tomography. J Glaucoma. 2018 Feb;27(2):157-163. doi: 10.1097/IJG.0000000000000833.
citation: Gmeiner JM, Schrems WA, Mardin CY, Laemmer R, Kruse FE, Schrems-Hoesl LM. Comparison of Bruch's Membrane Opening Minimum Rim Width and Peripapillary Retinal Nerve Fiber Layer Thickness in Early Glaucoma Assessment. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT575-84. doi: 10.1167/iovs.15-18906.
citation: Schrems-Hoesl LM, Schrems WA, Laemmer R, Horn FK, Juenemann AG, Kruse FE, Mardin CY. Confocal Laser Scanning Tomography to Predict Visual Field Conversion in Patients With Ocular Hypertension and Early Glaucoma. J Glaucoma. 2016 Apr;25(4):371-6. doi: 10.1097/IJG.0000000000000171.
citation: La Mancusa A, Horn FK, Kremers J, Huchzermeyer C, Rudolph M, Junemann A. Pattern electroretinograms during the cold pressor test in normals and glaucoma patients. Invest Ophthalmol Vis Sci. 2014 Apr 7;55(4):2173-9. doi: 10.1167/iovs.13-13392.
citation: Horn FK, Tornow RP, Junemann AG, Laemmer R, Kremers J. Perimetric measurements with flicker-defined form stimulation in comparison with conventional perimetry and retinal nerve fiber measurements. Invest Ophthalmol Vis Sci. 2014 Apr 11;55(4):2317-23. doi: 10.1167/iovs.13-12469.
citation: Horn FK, Kaltwasser C, Junemann AG, Kremers J, Tornow RP. Objective perimetry using a four-channel multifocal VEP system: correlation with conventional perimetry and thickness of the retinal nerve fibre layer. Br J Ophthalmol. 2012 Apr;96(4):554-9. doi: 10.1136/bjophthalmol-2011-300844. Epub 2011 Nov 24.
citation: Barboni MT, Pangeni G, Ventura DF, Horn F, Kremers J. Heterochromatic flicker electroretinograms reflecting luminance and cone opponent activity in glaucoma patients. Invest Ophthalmol Vis Sci. 2011 Aug 29;52(9):6757-65. doi: 10.1167/iovs.11-7538.