Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma

Ocular Hypertension Clinical Trial

Official title:

Glaucoma Including Pseudoexfoliation Syndrome (SFB 539)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00494923
• Other study ID #: DFG-SFB539-R
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2007
• Last updated: December 11, 2013
• Start date: January 1999
• Est. completion date: December 2020

Study information

• Verified date: December 2013
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Anselm G Juenemann, Prof.
• Phone: **49-9131-8533001
• Email: anselm.juenemann[@]uk-erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. The primary aim is the evaluation of diagnostic and prognostic validity of morphometrical, sensory and hemodynamical diagnostic procedures. No therapeutic studies are performed.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2020
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Primary Open Angle Glaucoma
• Secondary Open Angle Glaucoma

Locations

Country	Name	City	State
Germany	University Eye Hospital	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (11)

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. — View 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.0b013e3 — View Citation

Horn FK, Lämmer R, Mardin CY, Jünemann 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):2 — View 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. — View 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. Epub 2005 Sep 21. — View 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. — View Citation

Pasutto F, Krumbiegel M, Mardin CY, Paoli D, Lämmer R, Weber BH, Kruse FE, Schlötzer-Schrehardt U, Reis A. Association of LOXL1 common sequence variants in German and Italian patients with pseudoexfoliation syndrome and pseudoexfoliation glaucoma. Invest — View 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 Ophthal — View 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. — View Citation

Tornow RP, Schrems WA, Bendschneider D, Horn FK, Mayer M, Mardin CY, Lämmer 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 — View 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/i — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Disease Progression		up to 20 years	No