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COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228149
First Posted: October 26, 2010
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katrin Lorenz, Johannes Gutenberg University Mainz
Results First Submitted: April 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Trabeculectomy with preoperative Diamox/DexaEDO treatment
Drug: Trabeculectomy with preoperative Cosopt S treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Diamox/DexaEDO

Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally.

Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed.

Cosopt S

Patients receive Cosopt S eye drops starting 28 days preoperatively

Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed.


Participant Flow:   Overall Study
    Diamox/DexaEDO   Cosopt S
STARTED   32   30 
COMPLETED   27   26 
NOT COMPLETED   5   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Diamox/DexaEDO

Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.

Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed.

Cosopt S

Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively

Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed.

Total Total of all reporting groups

Baseline Measures
   Diamox/DexaEDO   Cosopt S   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   30   62 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      17  53.1%      12  40.0%      29  46.8% 
>=65 years      15  46.9%      18  60.0%      33  53.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (10.51)   65.8  (8.82)   64.98  (9.68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  59.4%      12  40.0%      31  50.0% 
Male      13  40.6%      18  60.0%      31  50.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Germany   32   30   62 


  Outcome Measures
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1.  Primary:   Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Needling   [ Time Frame: 12 weeks ]

3.  Secondary:   Number of Necessary 5-Fluorouracil (5FU) Injections   [ Time Frame: 12 weeks ]

4.  Secondary:   Ocular Hypotension Rate   [ Time Frame: 24 weeks ]

5.  Secondary:   Change in IOP Between Visit 1 and 2   [ Time Frame: 28 days ]

6.  Secondary:   Filtration Bleb Classification   [ Time Frame: 24 weeks ]

7.  Secondary:   Change in Quality of Life   [ Time Frame: 12 weeks ]

8.  Secondary:   Change in Conjunctival Redness   [ Time Frame: 24 weeks ]

9.  Secondary:   Number of Suture Lyses   [ Time Frame: week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Dr. Katrin Lorenz
Organization: Dept. of Ophthalmology, University Medical Center Mainz
phone: 00496131174069
e-mail: lorenz@augen.klinik.uni-mainz.de



Responsible Party: Katrin Lorenz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01228149     History of Changes
Other Study ID Numbers: 35131; EUDRA CT 2010-019975-30
First Submitted: August 20, 2010
First Posted: October 26, 2010
Results First Submitted: April 27, 2015
Results First Posted: April 14, 2017
Last Update Posted: August 1, 2017



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