Nerve Fiber Bundle DefectNCT01422525
Changes of the Peripapillary Retinal Nerve Fiber Layer After Filtration Surgery in Glaucoma Patients
An observational study of Nerve Fiber Bundle Defect and Optic Nerve Diseases, run by University Eye Hospital, Würzburg at 1 site in Germany.
Trial summary
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma. The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Fiber Bundle Defect, Optic Nerve Diseases
- What is being tested?
- spectral domain optical coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Feb 2012
- 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 may be able to join
- primary or secondary open angle glaucoma
- target intraocular pressure under medical treatment was not reached
- progression of visual loss
- best corrected visual acuity of 20/100 or more
- spherical equivalent refraction of -8.0 to +4.0 D
- perimetry: less than 20% false positive answers
Who cannot join
- primary or secondary angle closure glaucoma
- congenital glaucoma
- normal tension glaucoma
- neovascular glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.
The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.
Read the detailed description
Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering.
The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.
- Conditions
- Nerve Fiber Bundle Defect, Optic Nerve Diseases
- Being tested
- spectral domain optical coherence tomography
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectral domain optical coherence tomographyProcedure or surgery
RNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy RNFL thickness OCT | Not described Receives: Procedure: spectral domain optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of retinal nerve fiber layer thickness
study was terminated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
Why it stopped: short of study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Fiber Bundle DefectStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Eye Hospital, Würzburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliane Matlach, MD, University Eye Hospital, Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422525
- Sponsor's protocol ID
- OCT-TET
- Status last verified
- Dec 2014
- First submitted
- 21 Aug 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01422525
- Acronym / sponsor ID
- OCT-TET
- Conditions
- Nerve Fiber Bundle Defect, Optic Nerve Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: short of study staff
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Eye Hospital, WürzburgUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- First posted
- 24 Aug 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.
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.
The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.
Detailed description
Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering.
The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy RNFL thickness OCT | – | Procedure: spectral domain optical coherence tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patients
Key inclusion criteria (6 listed)
- primary or secondary open angle glaucoma
- target intraocular pressure under medical treatment was not reached
- progression of visual loss
- best corrected visual acuity of 20/100 or more
- spherical equivalent refraction of -8.0 to +4.0 D
Key exclusion criteria (4 listed)
- primary or secondary angle closure glaucoma
- congenital glaucoma
- normal tension glaucoma
- neovascular glaucoma
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 |
|---|---|---|
| spectral domain optical coherence tomographyRNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively. | Procedure or surgery | Trabeculectomy RNFL thickness OCT |
Primary outcome
change of retinal nerve fiber layer thickness
Time frame: 6 months
study was terminated
Results and safety
The study was stopped early (reason given: short of study staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nerve Fiber Bundle Defect and Optic Nerve Diseases, run by University Eye Hospital, Würzburg 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Dec 2014. 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 was stopped early (reason given: short of study staff). Results are not available in the source record.
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?
change of retinal nerve fiber layer thickness (time frame: 6 months). 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 2 Dec 2014.