GlaucomaPhase 4NCT00801658
Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
A Phase 4 study testing selective Laser Trabeculoplasty (SLT) in people with Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed. 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 (SLT)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Jul 2009
- Phase
- Phase 4
- 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
- primary open angle glaucoma (including normal tension glaucoma)
- pseudoexfoliation glaucoma
- pigment dispersion glaucoma
- Exclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed.
Read the detailed description
SLT (Selective Laser Trabeculoplasty) uses the Nd:YAG-Lasers (wavelength 532nm, Q-switched, frequency-doubled). Thanks to the low laser energy used and the short duration of treatment, only pigmented cells of the trabecular meshwork are targeted and selectively treated. Neighboring, non-pigmented cells and tissue are spared collateral and thermic damage, the architecture of the trabecular meshwork remains intact. The SLT procedure uses less than 1% of the energy of the ALT procedure with an extremely low pulsation duration.
Several studies confirm the effective IOD reduction of SLT and rate the procedure as an relatively safe and effective therapy for glaucoma. Also repeated use of the SLT procedure is considered as meaningful. Meanwhile the SLT procedure is used as primary and supplementary treatment of glaucoma and study confirmed that the SLT procedure was just as effective as administration of Latanoprost in reducing IOD in newly-diagnosed glaucoma.
- Conditions
- Glaucoma
- Being tested
- selective Laser Trabeculoplasty (SLT)
- Keywords
- glaucoma, SLT, Laser treatment, IOP, glaucoma treated with eye drops but IOP not controlled
- 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 Trabeculoplasty (SLT)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP lowering effect of SLT in a special patient group
Measured: 1 day, 1 , 3, 6 , 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJan 2008
- Study completionJul 2009
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 University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801658
- Sponsor's protocol ID
- FunkSLT
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
- ClinicalTrials.gov ID
- NCT00801658
- Acronym / sponsor ID
- FunkSLT
- Conditions
- Glaucoma
- Keywords
- glaucoma, SLT, Laser treatment, IOP, glaucoma treated with eye drops but IOP not controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
- Study start
- Jan 2008
- Study completion
- Jul 2009
- First posted
- 3 Dec 2008 (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.
Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed.
Detailed description
SLT (Selective Laser Trabeculoplasty) uses the Nd:YAG-Lasers (wavelength 532nm, Q-switched, frequency-doubled). Thanks to the low laser energy used and the short duration of treatment, only pigmented cells of the trabecular meshwork are targeted and selectively treated. Neighboring, non-pigmented cells and tissue are spared collateral and thermic damage, the architecture of the trabecular meshwork remains intact. The SLT procedure uses less than 1% of the energy of the ALT procedure with an extremely low pulsation duration.
Several studies confirm the effective IOD reduction of SLT and rate the procedure as an relatively safe and effective therapy for glaucoma. Also repeated use of the SLT procedure is considered as meaningful. Meanwhile the SLT procedure is used as primary and supplementary treatment of glaucoma and study confirmed that the SLT procedure was just as effective as administration of Latanoprost in reducing IOD in newly-diagnosed glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary open angle glaucoma (including normal tension glaucoma)
- pseudoexfoliation glaucoma
- pigment dispersion glaucoma
- Exclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork
Key exclusion criteria (0 listed)
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 Trabeculoplasty (SLT) | Device | – |
Primary outcome
IOP lowering effect of SLT in a special patient group
Time frame: 1 day, 1 , 3, 6 , 12 months postoperative
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 4 Dec 2008.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing selective Laser Trabeculoplasty (SLT) in people with Glaucoma, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 0 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 4 Dec 2008. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IOP lowering effect of SLT in a special patient group (time frame: 1 day, 1 , 3, 6 , 12 months postoperative). 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 4 Dec 2008.