Glaucoma and Ocular HypertensionNCT02231515
Prospective,Randomized,Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG
A study testing Selective laser trabeculoplasty (SLT) and Pattern laser trabeculoplasty (PLT) in people with Glaucoma and Ocular Hypertension, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma and Ocular Hypertension
- What is being tested?
- Selective laser trabeculoplasty (SLT) and Pattern laser trabeculoplasty (PLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Jun 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 (OAG) including pseudo-exfoliative and pigmentary glaucoma
- Patients requiring bilateral laser trabeculoplasty for IOP control
- Structural glaucomatous damage and/or documented glaucomatous VF damage (in the previous 12 months with mean defect (MD) > 2.5 dB
- No or stable anti-glaucomatous drug therapy since at least 3 months. Able to undergo medication washout for 4 weeks prior to baseline 24-h IOP monitoring session.
- Aged ≥18 years, of either sex
- Not more than 6 diopters spherical equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures
Who cannot join
- Refractory glaucoma
- Patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma.
- Corneal or conjunctival abnormality precluding contact lens adaptation
- Severe dry eye syndrome
- Patients with allergy to corneal anesthetic
- Patients with contraindications for silicone contact lens wear
Show all 9Show fewer
- Patients not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Any other contra-indication listed in the CLS (SENSIMED Triggerfish) user manual
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève, Ophtalmology Department
Geneva
About this study
Official title: A Prospective, Randomized, Controlled Study to Assess Efficacy,Safety, and Tolerability of Selective Laser Trabeculoplasty vs. Pattern Laser Trabeculoplasty in Patients With Open-angle Glaucoma
A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle glaucoma.
Read the detailed description
This is a prospective, randomised, controlled study. Patients will be selected for this study who require bilateral laser trabeculoplasty for IOP control. Eyes will undergo a medication wash-out 4 weeks prior to the baseline study session (S1). There will be a security visit at 2 weeks to make sure that the IOPs remain within a safe range. Following S1 both study eyes will receive laser treatment, as assigned by randomization, within a period of 2 weeks. Eyes will be randomized to receive the SLT (SLT eye) or PLT (PLT eye) treatment. Both laser procedures will be performed in one session (for 360° of the angle), if patients tolerate it. Otherwise, they will be split into two sessions (each treating 180° of the angle) to be performed within 1 week of each other. The same pre- and post-laser procedures will be applied on both eyes.
After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. The CLS will be placed on both eyes for a baseline 24-hour IOP pattern recording session (S1), within 2 weeks preceding the laser treatment. Patients will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual lifestyle as possible. At hour 24, patients will return to the clinic, the device will be removed and a final ophthalmic examination will be conducted. Patient diary will be collected and concomitant medication will be reported.
Following S1 both study eyes will receive either SLT or PLT laser treatment, as assigned by randomization (1:1), within a period of 2 weeks. The same pre- and post-laser procedures will be applied on both eyes.
At S2 (1 month after laser treatment) patients will be randomized to 24-hour CLS recording on either the SLT or on the PLT eye (1:1). The same ophthalmic examinations as during S1 will be conducted and patient diary collected.
At month 3 patients will be followed up with a slit lamp examination and IOP measurement. At months 6 and 12, patients will be seen for a complete ophthalmic examination including visual field exam (Octopus, Switzerland), optic nerve and retinal nerve fiber layer evaluation (Spectralis OCT, Germany). The overall study duration for the patient is limited to up to 14 months.
- Conditions
- Glaucoma and Ocular Hypertension
- Being tested
- Selective laser trabeculoplasty (SLT), Pattern laser trabeculoplasty (PLT)
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective laser trabeculoplasty (SLT)Device
Selective laser trabeculoplasty
Pattern laser trabeculoplasty (PLT)Device
Pattern laser trabeculoplasty (PLT)
| Study group | Role | What they receive |
|---|---|---|
| Pattern laser trabeculoplasty (PLT) | Experimental | Pattern laser trabeculoplasty Receives: Device: Pattern laser trabeculoplasty (PLT) |
| Selective laser trabeculoplasty (SLT) | Active comparator | Selective laser trabeculoplasty (SLT) Receives: Device: Selective laser trabeculoplasty (SLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Measured: 1 month
Secondary outcomes (2)
o Complete success: Reduction of at least 20% in IOP without medication
Complete success: Reduction of at least 20% in IOP without medication
Measured: 1 month
o Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionJun 2016
Why it stopped: departure of principal investigator from the organisation
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 Glaucoma and Ocular HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kaweh Mansouri, University Hospital, Geneva
- Investigators
- Kaweh Mansouri, Principal investigator, Ophtalmology department - Hôpitaux Universitaires de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231515
- Sponsor's protocol ID
- 1219
- Status last verified
- May 2023
- First submitted
- 22 Aug 2014
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- 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 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study to Assess Efficacy,Safety, and Tolerability of Selective Laser Trabeculoplasty vs. Pattern Laser Trabeculoplasty in Patients With Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT02231515
- Acronym / sponsor ID
- 1219
- Conditions
- Glaucoma and Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of principal investigator from the organisation
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Sep 2014 (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.
A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle glaucoma.
Detailed description
This is a prospective, randomised, controlled study. Patients will be selected for this study who require bilateral laser trabeculoplasty for IOP control. Eyes will undergo a medication wash-out 4 weeks prior to the baseline study session (S1). There will be a security visit at 2 weeks to make sure that the IOPs remain within a safe range. Following S1 both study eyes will receive laser treatment, as assigned by randomization, within a period of 2 weeks. Eyes will be randomized to receive the SLT (SLT eye) or PLT (PLT eye) treatment. Both laser procedures will be performed in one session (for 360° of the angle), if patients tolerate it. Otherwise, they will be split into two sessions (each treating 180° of the angle) to be performed within 1 week of each other. The same pre- and post-laser procedures will be applied on both eyes.
After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. The CLS will be placed on both eyes for a baseline 24-hour IOP pattern recording session (S1), within 2 weeks preceding the laser treatment. Patients will remain ambulatory and will be encouraged to follow a schedule as close to his/her usual lifestyle as possible. At hour 24, patients will return to the clinic, the device will be removed and a final ophthalmic examination will be conducted. Patient diary will be collected and concomitant medication will be reported.
Following S1 both study eyes will receive either SLT or PLT laser treatment, as assigned by randomization (1:1), within a period of 2 weeks. The same pre- and post-laser procedures will be applied on both eyes.
At S2 (1 month after laser treatment) patients will be randomized to 24-hour CLS recording on either the SLT or on the PLT eye (1:1). The same ophthalmic examinations as during S1 will be conducted and patient diary collected.
At month 3 patients will be followed up with a slit lamp examination and IOP measurement. At months 6 and 12, patients will be seen for a complete ophthalmic examination including visual field exam (Octopus, Switzerland), optic nerve and retinal nerve fiber layer evaluation (Spectralis OCT, Germany). The overall study duration for the patient is limited to up to 14 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pattern laser trabeculoplasty (PLT) | Experimental | Device: Pattern laser trabeculoplasty (PLT)Pattern laser trabeculoplasty |
| Selective laser trabeculoplasty (SLT) | Active comparator | Device: Selective laser trabeculoplasty (SLT)Selective laser trabeculoplasty (SLT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma
- Patients requiring bilateral laser trabeculoplasty for IOP control
- Structural glaucomatous damage and/or documented glaucomatous VF damage (in the previous 12 months with mean defect (MD) > 2.5 dB
- No or stable anti-glaucomatous drug therapy since at least 3 months. Able to undergo medication washout for 4 weeks prior to baseline 24-h IOP monitoring session.
- Aged ≥18 years, of either sex
Key exclusion criteria (9 listed)
- Refractory glaucoma
- Patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma.
- Corneal or conjunctival abnormality precluding contact lens adaptation
- Severe dry eye syndrome
- Patients with allergy to corneal anesthetic
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)Selective laser trabeculoplasty | Device | Selective laser trabeculoplasty (SLT) |
| Pattern laser trabeculoplasty (PLT)Pattern laser trabeculoplasty (PLT) | Device | Pattern laser trabeculoplasty (PLT) |
Primary outcome
• Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Time frame: 1 month
Change in IOP from baseline to 1 month post-surgery as measured by tonometry
2 secondary outcomes
o Complete success: Reduction of at least 20% in IOP without medication
Time frame: 1 month
o Qualified success: Reduction of at least 20% in IOP with IOP-lowering medication
Time frame: 1 Month
Results and safety
The study was stopped early (reason given: departure of principal investigator from the organisation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- 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.
Kaweh Mansouri principal investigator
Ophtalmology department - Hôpitaux Universitaires de Genève
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 (SLT) and Pattern laser trabeculoplasty (PLT) in people with Glaucoma and Ocular Hypertension, run by University Hospital, Geneva 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 May 2023. 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 was stopped early (reason given: departure of principal investigator from the organisation). Results are not available in the source record.
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 IOP from baseline to 1 month post-surgery as measured by tonometry (time frame: 1 month). 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 NCT02231515, 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 18 May 2023.