Status:
COMPLETED
Study of Medical Treatment of Low-Pressure (Normal Tension) Glaucoma
Lead Sponsor:
Chicago Center for Vision Research
Conditions:
Glaucoma, Open Angle
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
Low-pressure (normal tension) glaucoma is a type of open-angle glaucoma resulting in damage to the optic nerve and abnormalities of the visual field. Eye (intraocular) pressure in this type of glaucom...
Detailed Description
The term glaucoma describes a specific pattern of optic nerve head and visual field damage caused by a number of different diseases of the eye, most (but not all) of which are associated with an eleva...
Eligibility Criteria
Inclusion
- Age: 30 years or older.
- Low-pressure glaucoma in at least one eye: untreated IOP \< 21 mmHg, glaucomatous field loss on Humphrey 24-2 perimetry, and optic disc cupping.
- Best corrected visual acuity at least 20/40 in at least one eye.
- At least two visual fields within the 6 months prior to enrollment.
- Phakic or pseudophakic (cataract surgery \> one year to enrollment) eye.
Exclusion
- Either eye patient exclusion:
- Past history of confirmed treated or untreated applanation IOP \> 21 mmHg.
- Untreated IOP of \> 21 mmHg on diurnal curve on Study Day 0.
- Untreated IOP \> 4 mmHg difference between the two eyes.
- Extensive field damage: MD \> 15 dB or threat fixation in both hemi fields.
- Evidence of exfoliation or pigment dispersion.
- History of angle-closure or occludable gonioscopic anterior chamber angle.
- Prior filtration surgery.
- Prior laser iridotomy.
- Laser trabeculoplasty \< 6 months prior enrollment or for an IOP \> 21 mmHg.
- History of chronic inflammatory eye diseases (e.g., scleritis, uveitis).
- History or signs of intraocular trauma.
- Severe or potentially progressive retinal disease.
- Any abnormality preventing reliable applanation tonometry.
- History of hypersensitivity to study medications or their components.
- Current use of any ophthalmic, dermatologic or systemic steroid preparation.
- Therapy with another investigational agent within the past 30 days.
- Single eye exclusion:
- Cataract surgery within the past year.
- Aphakia.
- Only sighted eye.
- Concomitant conditions:
- Resting pulse \< 50 beats per minute.
- Unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
- Recent heart attack or stroke.
- Women contemplating pregnancy, who are pregnant or are a nursing mother.
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00317577
Start Date
December 1 1998
End Date
May 1 2004
Last Update
April 25 2006
Active Locations (12)
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1
Little Rock Eye Clinic
Little Rock, Arkansas, United States, 72205
2
University of Florida
Gainesville, Florida, United States, 32610
3
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States, 33418
4
University Eye Specialists
Chicago, Illinois, United States, 60611