Status:
COMPLETED
Influence of Prostaglandins on Ocular Blood Flow in Glaucoma Patients
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Open-Angle Glaucoma
Eligibility:
All Genders
55-85 years
Phase:
PHASE4
Brief Summary
Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The purpose of thi...
Detailed Description
Background Glaucoma is a leading cause of blindness worldwide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic ...
Eligibility Criteria
Inclusion
- 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 after washout. No closed iridocorneal angles, evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion, or any form of retinal or neuroophthalmologic disease that could result in visual field defects. No history of drug or alcohol abuse.
Exclusion
- Best corrected visual acuity worse than 2/10 in either eye \< 0.2 Snellen. Inadequate transparency of ocular media as defined by physical examination. Severe central field loss defined as a sensitivity \< 10dB in at least 2 of the 4 visual field test points closest to the point of fixation. Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of both eyes, including an ametropia \>3 dpt. 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. A known hypersensitivity to the compounds tested. Need for any concomitant medications that may interfere with the evaluation of ocular blood flow. Variability \> 30 % during Laser Doppler Flowmetry (sample of 6 measurements) in both eyes. Pregnancy, breastfeeding, or women in childbearing age without adequate contraception.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00308945
Start Date
November 1 2003
End Date
February 1 2005
Last Update
January 17 2008
Active Locations (1)
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1
University Eye Clinic
Basel, Canton of Basel-City, Switzerland, 4031