Early Diagnosis, Pathogenesis and Progression of Open Ang... | NCT00494923

Studies
Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma

NCT00494923

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Unknown status

Last Update Posted

Dec 12, 2013Estimated

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Primary Open Angle Glaucoma
Secondary Open Angle Glaucoma
Ocular Hypertension

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 29, 2007

First Submission Date that Met QC Criteria

Jun 29, 2007

First Posted Date

Jul 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2013

Last Update Posted Date

Dec 12, 2013Estimated

Name	Class
German Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,500Estimated

Measure	Description	Time Frame
Time to Disease Progression		up to 20 years

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anselm G Juenemann, Prof.	Contact	**49-9131-8533001		anselm.juenemann@uk-erlangen.de

Overall Officials

Name	Affiliation	Role
Anselm G Juenemann, Prof.	University Erlangen-Nuremberg	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital	Recruiting	Erlangen		91054	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23633657	Result	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.
22027931	Result	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.

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases