GlaucomaSLT/OBFNCT01363362
Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma
A study testing Selective Laser Trabeculoplasty in people with Glaucoma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Selective Laser Trabeculoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Aug 2011
- Phase
- Interventional
- 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
Who may be able to join
- glaucoma patient
- over 18 years
- needs further intraocular pressure regulation
Who cannot join
- age under 18 years
- debilitated
- no glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma
Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.
Read the detailed description
Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.
- Conditions
- Glaucoma
- Being tested
- Selective Laser Trabeculoplasty
- Keywords
- Selective Laser Trabeculoplasty, pulsatile ocular blood flow
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Laser TrabeculoplastyProcedure or surgery
Also called Lasertrabeculoplasty
360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ
| Study group | Role | What they receive |
|---|---|---|
| glaucoma patients | Experimental | Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction Receives: Procedure: Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)
Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.)
Measured: baseline and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- Lutz E Pillunat, Prof. MD, Study chair, University Eye Clinic Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363362
- Sponsor's protocol ID
- SLT/OBF_EK 398122010
- Acronym
- SLT/OBF
- Status last verified
- Dec 2012
- First submitted
- 27 May 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma
- ClinicalTrials.gov ID
- NCT01363362
- Acronym / sponsor ID
- SLT/OBF / SLT/OBF_EK 398122010
- Conditions
- Glaucoma
- Keywords
- Selective Laser Trabeculoplasty, pulsatile ocular blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Jun 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.
Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.
Detailed description
Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glaucoma patients | Experimental | Procedure: Selective Laser TrabeculoplastyGlaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- glaucoma patient
- over 18 years
- needs further intraocular pressure regulation
Key exclusion criteria (3 listed)
- age under 18 years
- debilitated
- no 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 |
|---|---|---|
| Selective Laser TrabeculoplastyAlso: Lasertrabeculoplasty360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ | Procedure or surgery | glaucoma patients |
Primary outcome
Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)
Time frame: baseline and 3 month
Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.)
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 18 Dec 2012.
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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.
Lutz E Pillunat, Prof. MD study chair
University Eye Clinic Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Laser Trabeculoplasty in people with Glaucoma, 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 3 inclusion and 3 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 18 Dec 2012. 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?
Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT) (time frame: baseline and 3 month). 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 18 Dec 2012.