COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Trabeculectomy with preoperative Diamox/DexaEDO treatment; Trabeculectomy with preoperative Cosopt S treatment
Intervention description: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery; Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.
Intervention MeSH terms: Acetazolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma; trabeculectomy; intraocular pressure

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 risk of post-operative scarring of the filtration bleb. Therefore many surgeons
      prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs,
      controlling IOP with oral acetazolamide, and treating the eye with local steroids.

      Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP
      preoperatively with the aim of avoiding postoperative excessive scarring and the known
      adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term
      outcomes.

      This study will investigate comparability (non-inferiority) of medical benefits of two
      different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing
      COSOPT-S® bid to oral acetazolamide plus dexamethasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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