Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography

Completed

• Conditions: Glaucoma; Filtering Blebs
• Interventions: Procedure: trabeculectomy

• Registration Number: NCT01391676
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trabeculectomy	trabeculectomy	glaucoma patients undergoing trabeculectomy with mitomycin c 0,02%

Primary Outcome Measures

Name	Time	Method
grading of filtering bleb	December 2011

Trial Locations

Locations (1)

University Eye Clinic Dresden; 🇩🇪 Dresden, Saxony, Germany