Choroidal Blood Flow Response to Hand-grip Test in Progressive Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00284440

Recruitment Status : Withdrawn (enrollment problems)

First Posted : January 31, 2006

Last Update Posted : March 10, 2015

Sponsor:

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

Tracking Information

First Submitted Date

January 30, 2006

First Posted Date

January 31, 2006

Last Update Posted Date

March 10, 2015

Study Start Date

March 2006

Actual Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Choroidal Blood Flow Response to Hand-grip Test in Progressive Glaucoma

Official Title

Relationship Between Visual Field Progression in Glaucoma and Choroidal Blood Flow Response to the Hand-grip Test

Brief Summary

The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.

Detailed Description

Glaucoma is a worldwide leading cause of blindness. The key features of glaucoma are damage to the optic nerve head and progressive visual field defect, which is not necessarily only related to an increase in intraocular pressure. It has been suggested that ocular blood flow alterations in glaucoma are related to systemic vascular dysregulations.The hand-grip test has been suggested as a potential tool to unravel vascular dysregulation in the ocular circulation. Although applied routinely in clinical practice, a proper study testing the effectiveness of this test is lacking. The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.

Study Type

Observational

Study Design

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients with glaucoma

Condition

Primary Open Angle Glaucoma

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Gugleta K, Orgül S, Hasler PW, Picornell T, Gherghel D, Flammer J. Choroidal vascular reaction to hand-grip stress in subjects with vasospasm and its relevance in glaucoma. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1573-80.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Withdrawn

Actual Enrollment

Original Enrollment

Actual Study Completion Date

June 2011

Actual Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria: Patients fulfilling two out of three of the following criteria in one or both eyes: a) typical glaucomatous disc, b) visual field damage (a cluster of three points (except rim points) in at least one hemifield reduced by 5 dB or greater and including at least one point reduced by 10 dB or greater; a cluster of two points reduced by 10 dB or greater; or three adjacent points on the nasal horizontal meridian that differed by 5 dB or greater from their mirror points on the opposite side of the meridian), c) intraocular pressure above 21 mm Hg at least at one occasion. Furthermore, patients need to have a series of at least 5 visual field examinations, after exclusion of the first test, for assessment of progression.

Exclusion Criteria:

Ametropia > 3dpt
Inadequate transparency of ocular media as defined by physical examination
Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of at least one eye
History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis
History of ocular trauma or intraocular surgery within the past 6 months
History of infection or inflammation within the past 3 months
History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment
Patients with a significant history and/or active alcohol or drug abuse (significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study).

Sex/Gender

Sexes Eligible for Study:

All

Ages

30 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Switzerland

Removed Location Countries

Administrative Information

NCT Number

NCT00284440

Other Study ID Numbers

072-Leh-2005-001

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University Hospital, Basel, Switzerland

Study Sponsor

University Hospital, Basel, Switzerland

Collaborators

Not Provided

Investigators

Principal Investigator:

Selim Orguel, MD

Chief of department of diagnostics

PRS Account

University Hospital, Basel, Switzerland

Verification Date

March 2015

To Top