Open Angle GlaucomaSLTNCT02434250
Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy
A study testing Selective Laser Trabeculoplasty in people with Open Angle Glaucoma and Ocular Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension, Cataract
- 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
- 203 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Nov 2016
- 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
- diagnosis of open angle glaucoma or ocular hypertension
- and diagnosis of cataract
Who cannot join
- diagnosis of angle closure glaucoma
- any optic neuropathy other than glaucoma
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology
Zurich, Canton of Zurich, 8091
About this study
Official title: Effectiveness of Selective Laser Trabeculoplasty (SLT) After Failed Phacoemulsification Cataract Extraction Combined With Eximer Laser Trabeculectomy (Phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension
The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.
Read the detailed description
This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension, Cataract
- Being tested
- Selective Laser Trabeculoplasty
- Keywords
- Open angle glaucoma, Ocular hypertension, Cataract, Selective Laser Trabeculoplasty, Eximer Laser Trabeculectomy, Phacoemulsification Cataract Extraction
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Laser TrabeculoplastyProcedure or surgery
Selective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure.
| Study group | Role | What they receive |
|---|---|---|
| SLT arm | Experimental | Patient receiving 'Selective Laser Trabeculoplasty' (SLT) due to failed Phacoemulsification Cataract Extraction with Intraocular Lens Implantation combined with Eximer Laser Trabeculectomy (phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension to control intraocular pressure and/or glaucoma progression. Receives: Procedure: Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy intraocular pressure
Efficacy as measured by decrease in intraocular pressure from baseline
Measured: t0 and t=12 month
Efficacy medication
as measured by decrease in number of used hypotensive medications
Measured: t0 and t=12 month
Secondary outcomes (1)
Efficacy visual acuity
Efficacy as increase in best corrected visual acuity
Measured: t0 and t=12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Toeteberg-Harms, MD, FEBO, Principal investigator, UniversityHospital Zurich, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434250
- Sponsor's protocol ID
- SLT after Phaco-ELT
- Acronym
- SLT
- Status last verified
- Jun 2017
- First submitted
- 29 Jan 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Selective Laser Trabeculoplasty (SLT) After Failed Phacoemulsification Cataract Extraction Combined With Eximer Laser Trabeculectomy (Phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02434250
- Acronym / sponsor ID
- SLT / SLT after Phaco-ELT
- Conditions
- Open Angle Glaucoma, Ocular Hypertension, Cataract
- Keywords
- Open angle glaucoma, Ocular hypertension, Cataract, Selective Laser Trabeculoplasty, Eximer Laser Trabeculectomy, Phacoemulsification Cataract Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 May 2015 (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 aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.
Detailed description
This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLT arm | Experimental | Procedure: Selective Laser TrabeculoplastyPatient receiving 'Selective Laser Trabeculoplasty' (SLT) due to failed Phacoemulsification Cataract Extraction with Intraocular Lens Implantation combined with Eximer Laser Trabeculectomy (phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension to control intraocular pressure and/or glaucoma progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of open angle glaucoma or ocular hypertension
- and diagnosis of cataract
Key exclusion criteria (2 listed)
- diagnosis of angle closure glaucoma
- any optic neuropathy other than 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 TrabeculoplastySelective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure. | Procedure or surgery | SLT arm |
Primary outcome
Efficacy intraocular pressure
Time frame: t0 and t=12 month
Efficacy as measured by decrease in intraocular pressure from baseline
Efficacy medication
Time frame: t0 and t=12 month
as measured by decrease in number of used hypotensive medications
1 secondary outcome
Efficacy visual acuity
Time frame: t0 and t=12 month
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 20 Jun 2017.
- Individual participant dataSharing planned: No
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Active, not recruitingObservational study
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Primary Open-angle Glaucoma
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.
Marc Toeteberg-Harms, MD, FEBO principal investigator
UniversityHospital Zurich, Dept. of Ophthalmology
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 Open Angle Glaucoma and Ocular Hypertension, 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 2 inclusion and 2 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 20 Jun 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 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.
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?
Efficacy intraocular pressure (time frame: t0 and t=12 month). The study lists 2 primary outcomes in all. 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 20 Jun 2017.