Changes of the Peripapillary Retinal Nerve Fiber Layer Af... | NCT01422525

Studies
Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients

NCT01422525

Sponsor

University Eye Hospital, Würzburg

Status

Terminated

Last Update Posted

Dec 2, 2014Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Nerve Fiber Bundle Defect
Optic Nerve Diseases

Interventions

spectral domain optical coherence tomography

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 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

short of study staff

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Not provided

First Submitted Date

Aug 21, 2011

First Submission Date that Met QC Criteria

Aug 22, 2011

First Posted Date

Aug 24, 2011Estimated

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 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

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

At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.

The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.

Detailed Description

Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering.

The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.

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

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trabeculectomy RNFL thickness OCT			Procedure: spectral domain optical coherence tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spectral domain optical coherence tomography	Procedure	RNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of retinal nerve fiber layer thickness	study was terminated	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary or secondary open angle glaucoma
target intraocular pressure under medical treatment was not reached
progression of visual loss
best corrected visual acuity of 20/100 or more
spherical equivalent refraction of -8.0 to +4.0 D
perimetry: less than 20% false positive answers

Exclusion Criteria:

primary or secondary angle closure glaucoma
congenital glaucoma
normal tension glaucoma
neovascular glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

glaucoma patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital Wuerzburg		Würzburg	Bavaria	97080	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009901	Optic Nerve Diseases

Ancestor Terms

ID	Term
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided