Glaucoma, PrimaryTE-biomechNCT02287545
Biomechanical Changes After Trabeculectomy
An observational study of Glaucoma, Primary, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Primary
- What is being tested?
- trabeculectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Feb 2015
- 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: Primary open-angle glaucoma patients assigened for a trabeculectomy.
Who may be able to join
- Glaucoma patients in need of further IOP-reduction despite maximally tolerated therapy and assigned for trabeculectomy. Minimum of 18 years.
Who cannot join
- Corneal pathologies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Biomechanical Changes Following Trabeculectomy
Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy.
Read the detailed description
Prior to trabeculectomy corneal biomechanics are measured with the Ocular Response Analyzer (ORA, Reichert) and the Corvis st (Oculus). Both instruments work with an air-puff which deforms the cornea. Intraocular pressure is measured like in non-contact air-puff tonometry. The ORA also measures corneal hysteresis (CH) and the corneal resistance factor (CRF) which are qualitative measures of corneal biomechanics. The Corvis is a high-speed Scheimpflug-camera (4330 frames/sec) that records the quantitative movements of the cornea. At least 6 month after uncomplicated trabeculectomy the measurements are repeated.
- Conditions
- Glaucoma, Primary
- Being tested
- trabeculectomy
- Keywords
- open angle glaucoma, corneal biomechanics, trabeculectomy
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculectomyProcedure or surgery
Also called filtering glaucoma surgery
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control taking maximally tolerated IOP-reducing medication, visual field progression despite maximally tolerated IOP-reducing medication, adverse events because of maximally tolerated IOP-reducing medication or nono.compliance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma, primary | Glaucoma patients undergoing trabeculectomy Receives: Procedure: trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal biomechanical changes following trabeculectomy
Evaluation of biomechanical properties of the cornea before and after trabeculectomy to evaluate whether intraocular pressure is accurately measured after trabeculectomy. Corneal hysteresis and corneal resistance factor as measured with the Ocular Response Analyzer and the corneal deformation response to an air-puff as measured with an ultra-high-speed Scheimpflug camera are assessed.
Measured: 2-3 years
Secondary outcomes (1)
Intraocular pressure after trabeculectomy
Intraocular pressure is measured with 3 different devices (Goldmann applanation tonometry, Ocular Response Analyzer, Corvis st) prior and at least 6 month after trabeculectomy.
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, PrimaryStudies of the same condition, open and under way.
- 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 Pillunat, MD, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287545
- Sponsor's protocol ID
- EK399122012
- Acronym
- TE-biomech
- Status last verified
- Aug 2015
- First submitted
- 4 Nov 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Biomechanical Changes Following Trabeculectomy
- ClinicalTrials.gov ID
- NCT02287545
- Acronym / sponsor ID
- TE-biomech / EK399122012
- Conditions
- Glaucoma, Primary
- Keywords
- open angle glaucoma, corneal biomechanics, trabeculectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Nov 2014 (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.
Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy.
Detailed description
Prior to trabeculectomy corneal biomechanics are measured with the Ocular Response Analyzer (ORA, Reichert) and the Corvis st (Oculus). Both instruments work with an air-puff which deforms the cornea. Intraocular pressure is measured like in non-contact air-puff tonometry. The ORA also measures corneal hysteresis (CH) and the corneal resistance factor (CRF) which are qualitative measures of corneal biomechanics. The Corvis is a high-speed Scheimpflug-camera (4330 frames/sec) that records the quantitative movements of the cornea. At least 6 month after uncomplicated trabeculectomy the measurements are repeated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma, primary | – | Procedure: trabeculectomyGlaucoma patients undergoing trabeculectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary open-angle glaucoma patients assigened for a trabeculectomy.
Key inclusion criteria (1 listed)
- Glaucoma patients in need of further IOP-reduction despite maximally tolerated therapy and assigned for trabeculectomy. Minimum of 18 years.
Key exclusion criteria (1 listed)
- Corneal pathologies.
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 |
|---|---|---|
| trabeculectomyAlso: filtering glaucoma surgeryStandard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control taking maximally tolerated IOP-reducing medication, visual field progression despite maximally tolerated IOP-reducing medication, adverse events because of maximally tolerated IOP-reducing medication or nono.compliance. | Procedure or surgery | Glaucoma, primary |
Primary outcome
Corneal biomechanical changes following trabeculectomy
Time frame: 2-3 years
Evaluation of biomechanical properties of the cornea before and after trabeculectomy to evaluate whether intraocular pressure is accurately measured after trabeculectomy. Corneal hysteresis and corneal resistance factor as measured with the Ocular Response Analyzer and the corneal deformation response to an air-puff as measured with an ultra-high-speed Scheimpflug camera are assessed.
1 secondary outcome
Intraocular pressure after trabeculectomy
Time frame: 2-3 years
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 21 Aug 2015.
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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 Pillunat, MD principal investigator
Technische Universität Dresden
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, Primary, 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 21 Aug 2015. 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?
Corneal biomechanical changes following trabeculectomy (time frame: 2-3 years). 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 21 Aug 2015; AzTrials last refreshed its copy on 29 Oct 2026.