Status:
COMPLETED
COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
Lead Sponsor:
Katrin Lorenz
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased ris...
Detailed Description
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased ris...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years or older
- Caucasian
- A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- Planned trabeculectomy
- Previous treatment with antiglaucoma agents containing preservatives for at least one month
- Best corrected visual acuity of 20/800 or better in the study eye
Exclusion
- Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
- Current ocular infection, i.e. conjunctivitis or keratitis
- Any abnormality preventing reliable applanation tonometry
- Intraocular surgery or laser treatment within the past three months
- History of surgery involving the conjunctiva
- History of cataract surgery with sclerocorneal approach
- Subject is allergic to sulfonamides
- Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
- Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
- Severe renal dysfunction (CrCl \< 30 ml/min) or hyperchloraemic acidosis
- Depressed blood levels of sodium and / or potassium
- Marked kidney and liver disease or dysfunction, gout, suprarenal gland failure, hypercalciuria or nephrocalcinosis
- History of hypersensitivity to the investigational medicinal products or to any drug
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01228149
Start Date
August 1 2010
End Date
April 1 2014
Last Update
August 1 2017
Active Locations (1)
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1
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Mainz, Germany, 55131