COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

Phase 4

Completed

Conditions: Glaucoma

Interventions: Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment
Drug: Trabeculectomy with preoperative Cosopt S treatment

Registration Number: NCT01228149

Lead Sponsor: Katrin Lorenz

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 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.

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diamox/DexaEDO	Trabeculectomy with preoperative Diamox/DexaEDO treatment	Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.
Cosopt S	Trabeculectomy with preoperative Cosopt S treatment	Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP	12 weeks	Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery

Secondary Outcome Measures

Name	Time	Method
Number of Needling	12 weeks	number of patients requirering needling
Number of Necessary 5-Fluorouracil (5FU) Injections	12 weeks	Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12
Ocular Hypotension Rate	24 weeks	Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension
Change in IOP Between Visit 1 and 2	28 days	Change in IOP between Visit 1 (Screening visit 16 to 28 day prior trabeculectomy) and Visit 2 (1 day before trabeculectomy). Outcome shows mean of differences and 95% confidence intervall.
Filtration Bleb Classification	24 weeks	Filtration bleb classification (Grehn) in both Groups 1 week, 4 weeks, 12 weeks and 24 week after surgery. For classification the following criteria were evaluated and scored as described below: * vascularisation (0=None, 1=mild, 2=a few corkscrew vessels) * identifiability (0=no borders to sides; 1=demarcation nasally or temporally; 2= demarcation to both sides; 3= encapsulated) * Thickness (0= a least 3mm; 1=2mm; 2= 1mm; 3=flat) * Microcysts (0=no; 1= yes) * Transparency (0= highly transparent; 2=moderate; 2=not transparent) * Mobility (0= yes; 1= no) * Leakage (0=yes, 1=no) For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only.
Change in Quality of Life	12 weeks	Change in quality of life measure by a certified National Eye Institute Visual Functioning Questionnaire containing 25 questions (NEI VFQ-25).Patients tick a score at every question to present their visual functioning (usually from 1-5 or 1-6 in which 1 is best and 6 worse). Every single item/score is transformed to a scale between 0 and 100 (0 best, 100 worse). For the total score, the mean of all transformed scores/items is calculated. NEI VFQ 25 Quality of Life Questionnaire composite score at V5 (week 12 after surgery). Outcome shows mean of differences and 95% confidence intervall.
Change in Conjunctival Redness	24 weeks	Conjunctival redness (ORA Scale) evaluated from 16 up to 28 days (time window) prior surgery and 1 day prior surgery. The investigator compares patient's study eye with a set of reference photos showing various degrees of redness. Redness was scored on a scale of "none", "mild", "moderate", "severe" and "very severe". Absolute and relative frequencies of visit 1 and 2 were compared descriptively.
Number of Suture Lyses	week 12	Number of suture lyses at visit 5 (week 12 after surgery)