GlaucomaSLT/ORANCT01247831
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
A study testing Selective Laser Trabeculoplasty in people with Glaucoma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients. 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
- Nov 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 patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma
Who cannot join
- other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.
Read the detailed description
Ocular Rigidity (corneal hysteresis and corneal resistance factor) is measured with the Ocular Response Analyzer (Reichert) before and 4 weeks after SLT (Q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). The trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mJ.
The purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.
- Conditions
- Glaucoma
- Being tested
- Selective Laser Trabeculoplasty
- Keywords
- glaucoma, selective laser trabeculoplasty, ocular rigidity
- 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 SLT, ORA
100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser.
| Study group | Role | What they receive |
|---|---|---|
| glaucoma patients | Other | All of the patients treated with SLT need further IOP reduction for control of their glaucoma. 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 rigidity
Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty?
Measured: 4 weeks
Secondary outcomes (1)
IOP reduction
Is there an effective IOP drop after SLT?
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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
- Karin R Hornykewycz, MD, Principal investigator, University Eye Clinic Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247831
- Sponsor's protocol ID
- SLT/ORA/1
- Acronym
- SLT/ORA
- Status last verified
- Feb 2017
- First submitted
- 23 Nov 2010
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
- ClinicalTrials.gov ID
- NCT01247831
- Acronym / sponsor ID
- SLT/ORA / SLT/ORA/1
- Conditions
- Glaucoma
- Keywords
- glaucoma, selective laser trabeculoplasty, ocular rigidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Nov 2010 (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 purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.
Detailed description
Ocular Rigidity (corneal hysteresis and corneal resistance factor) is measured with the Ocular Response Analyzer (Reichert) before and 4 weeks after SLT (Q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). The trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mJ.
The purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glaucoma patients | Other | Procedure: Selective Laser TrabeculoplastyAll of the patients treated with SLT need further IOP reduction for control of their glaucoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma
Key exclusion criteria (1 listed)
- other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy
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: SLT, ORA100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser. | Procedure or surgery | glaucoma patients |
Primary outcome
change in ocular rigidity
Time frame: 4 weeks
Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty?
1 secondary outcome
IOP reduction
Time frame: 4 weeks
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 8 Feb 2017.
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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
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 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 8 Feb 2017. 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 rigidity (time frame: 4 weeks). 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 8 Feb 2017.