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

Primary Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00284440
• Other study ID #: 072-Leh-2005-001
• Status: Withdrawn
• Phase: N/A
• First received: January 30, 2006
• Last updated: March 9, 2015
• Start date: March 2006
• Est. completion date: June 2011

Study information

• Verified date: March 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Locations

Country	Name	City	State
Switzerland	University Eye Clinic	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation