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Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography (SDOCT-TE)

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ClinicalTrials.gov Identifier: NCT01391676
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Karin Pillunat, Technische Universität Dresden

Study Description
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Brief Summary:
The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.

Condition or disease Intervention/treatment
Glaucoma Filtering Blebs Procedure: trabeculectomy

Detailed Description:
After a trabeculectomy with mitomycin C 0,02% for 3 minutes, the blebs are controlled by a glaucoma specialist on day 1, week 1,2,3,4, month 3 and 6 after surgery. The glaucoma specialist will evaluate the bleb appearance according to a standardized protocol. At the same time points the bleb will be imaged with the spectral domain optical coherence tomography, to monitor bleb changes objectively. The investigators hope to see signs of bleb incapsulation and scarring earlier and then treat the patient accordingly.
Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Imaging of Blebs After Trabeculectomy With Mitomycin C 0,02% Using the Spectral Domain Optical Coherence Tomography
Study Start Date : March 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Trabeculectomy
glaucoma patients undergoing trabeculectomy with mitomycin c 0,02%
 Procedure: trabeculectomy
postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography


Outcome Measures
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Primary Outcome Measures :
  1. grading of filtering bleb [ Time Frame: December 2011 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure (IOP)
Criteria

Inclusion Criteria:

glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent

Exclusion Criteria:

patient without glaucoma, under 18 years of age, not willing to take part in the study

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391676


Locations
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Germany
University Eye Clinic Dresden
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: Karin R Hornykewycz, MD University Eye Clinic Dresden, Fetscherstrasse 74, 01307 Dresden, Germany
More Information
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Responsible Party: Dr. Karin Pillunat, Principal Investigator, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01391676    
Other Study ID Numbers: SD OCT-TE
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013
Keywords provided by Dr. Karin Pillunat, Technische Universität Dresden:
glaucoma
trabeculectomy
filtering bleb
spectral domain optical coherence tomography
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases