Prospective, Randomized, Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG
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|ClinicalTrials.gov Identifier: NCT02231515|
Recruitment Status : Unknown
Verified September 2014 by Dr. Kaweh Mansouri, University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : September 4, 2014
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma and Ocular Hypertension||Device: Selective laser trabeculoplasty (SLT) Device: Pattern laser trabeculoplasty (PLT)||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2016|
Experimental: Pattern laser trabeculoplasty (PLT)
Pattern laser trabeculoplasty
Device: Pattern laser trabeculoplasty (PLT)
Pattern laser trabeculoplasty (PLT)
Active Comparator: Selective laser trabeculoplasty (SLT)
Selective laser trabeculoplasty (SLT)
Device: Selective laser trabeculoplasty (SLT)
Selective laser trabeculoplasty
- • Change in IOP from baseline to 1 month post-surgery as measured by tonometry [ Time Frame: 1 month ]
- 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 ]
- • CLS derived parameters including: o Wake-to-Sleep slopes, as measured by the linear change in IOP from before going to bed to after [ Time Frame: 3 and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231515
|Contact: Kaweh Mansouri||+41 79 553 38 email@example.com|
|Hôpitaux Universitaires de Genève, Ophtalmology Department||Recruiting|
|Principal Investigator: Kaweh Mansouri|
|Principal Investigator:||Kaweh Mansouri||Ophtalmology department - Hôpitaux Universitaires de Genève|