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

This study has been terminated.
(enrollment problems)
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00284440
First received: January 30, 2006
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition
Primary Open Angle Glaucoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship Between Visual Field Progression in Glaucoma and Choroidal Blood Flow Response to the Hand-grip Test

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Enrollment: 0
Study Start Date: March 2006
Study Completion Date: June 2011
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with glaucoma

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.

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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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284440

Locations
Switzerland
University Eye Clinic
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Selim Orguel, MD Chief of department of diagnostics
  More Information

Publications:
Responsible Party: Selim Orguel, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00284440     History of Changes
Other Study ID Numbers: 072-Leh-2005-001
Study First Received: January 30, 2006
Last Updated: August 8, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Visual field progression
Choroidal blood flow

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014