GlaucomaSDOCT-TENCT01391676
Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography
An observational study of Glaucoma and Filtering Blebs, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Filtering Blebs
- What is being tested?
- trabeculectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure (IOP)
Who may be able to join
- glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent
Who cannot join
- patient without glaucoma, under 18 years of age, not willing to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging of Blebs After Trabeculectomy With Mitomycin C 0,02% Using the Spectral Domain Optical Coherence Tomography
The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.
Read the 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.
- Conditions
- Glaucoma, Filtering Blebs
- Being tested
- trabeculectomy
- Keywords
- glaucoma, trabeculectomy, filtering bleb, spectral domain optical coherence tomography
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculectomyProcedure or surgery
postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy | glaucoma patients undergoing trabeculectomy with mitomycin c 0,02% Receives: Procedure: trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
grading of filtering bleb
Measured: December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karin Pillunat, Technische Universität Dresden
- Investigators
- Karin R Hornykewycz, MD, Principal investigator, University Eye Clinic Dresden, Fetscherstrasse 74, 01307 Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391676
- Sponsor's protocol ID
- SD OCT-TE
- Acronym
- SDOCT-TE
- Status last verified
- Sep 2013
- First submitted
- 8 Jul 2011
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Blebs After Trabeculectomy With Mitomycin C 0,02% Using the Spectral Domain Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01391676
- Acronym / sponsor ID
- SDOCT-TE / SD OCT-TE
- Conditions
- Glaucoma, Filtering Blebs
- Keywords
- glaucoma, trabeculectomy, filtering bleb, spectral domain optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy | – | Procedure: trabeculectomyglaucoma patients undergoing trabeculectomy with mitomycin c 0,02% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure (IOP)
Key inclusion criteria (1 listed)
- glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent
Key exclusion criteria (1 listed)
- patient without glaucoma, under 18 years of age, not willing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trabeculectomypostoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography | Procedure or surgery | Trabeculectomy |
Primary outcome
grading of filtering bleb
Time frame: December 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin R Hornykewycz, MD principal investigator
University Eye Clinic Dresden, Fetscherstrasse 74, 01307 Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Filtering Blebs, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grading of filtering bleb (time frame: December 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013; AzTrials last refreshed its copy on 6 Nov 2026.