Open Angle Glaucoma,NCT01886456
IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients
A study testing Laser trabeculoplasty in people with Open Angle Glaucoma, and Ocular Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma,, Ocular Hypertension
- What is being tested?
- Laser trabeculoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Feb 2017
- 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
- Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) > 21 mm Hg
- visible angle structures over 360° on gonioscopy
- age = 18 years
Who cannot join
- Intraocular Inflammation
- patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
- monocle situation
- anterior chamber lenses (incl. iris claw)
- secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)
Trial locations and contacts
1 site in 1 country.
Gregor Jaggi, MD contact
Christoph Kniestedt, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Ophthalmology Clinic
Zurich, Canton of Zurich, 8091
About this study
Official title: Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension
To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.
Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.
- Trial with medical device
- Conditions
- Open Angle Glaucoma,, Ocular Hypertension
- Being tested
- Laser trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser trabeculoplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| PLT | Experimental | patients treated with patterned laser trabeculoplasty Receives: Device: Laser trabeculoplasty |
| SLT | Active comparator | patients treated with selective laser trabeculoplasty Receives: Device: Laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure 6 months after Intervention
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 posted25 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle Glaucoma,Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Kniestedt, MD, Principal investigator, University Hospital Zurich, Ophthalmology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886456
- Sponsor's protocol ID
- 14.1.2013_KEK ZH 2012-0422
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 25 Jun 2013
- Results posted
- No
Publications
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PubMed 35943114
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01886456
- Acronym / sponsor ID
- 14.1.2013_KEK ZH 2012-0422
- Conditions
- Open Angle Glaucoma,, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 25 Jun 2013 (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.
To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.
Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.
- Trial with medical device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLT | Experimental | Device: Laser trabeculoplastypatients treated with patterned laser trabeculoplasty |
| SLT | Active comparator | Device: Laser trabeculoplastypatients treated with selective laser trabeculoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) > 21 mm Hg
- visible angle structures over 360° on gonioscopy
- age = 18 years
Key exclusion criteria (5 listed)
- Intraocular Inflammation
- patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
- monocle situation
- anterior chamber lenses (incl. iris claw)
- secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)
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 |
|---|---|---|
| Laser trabeculoplasty | Device | PLT, SLT |
Primary outcome
Intraocular pressure 6 months after Intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Derived from this study: PubMed 35943114Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
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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.
Gregor Jaggi, MD contact
Christoph Kniestedt, MD contact
Christoph Kniestedt, MD principal investigator
University Hospital Zurich, Ophthalmology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregor Jaggi, MD (gregor.jaggi@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure 6 months after Intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886456, which also lists 1 linked publication.
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 25 Jun 2013.