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NCT01391676 Clinical Trial

Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography

Glaucoma Clinical Trial

— SDOCT-TE  

Official title:
Imaging of Blebs After Trabeculectomy With Mitomycin C 0,02% Using the Spectral Domain Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01391676
Other study ID # SD OCT-TE
Secondary ID
Status Completed
Phase N/A
First received July 8, 2011
Last updated September 9, 2013
Start date March 2011
Est. completion date December 2011

Study information
Verified date September 2013
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• trabeculectomy
postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography

Locations
Country Name City State
Germany University Eye Clinic Dresden Dresden Saxony

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary grading of filtering bleb December 2011 No
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