EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA (ETSG)
Primary Open Angle Glaucoma
Device: external slt
Device: standard slt
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pioneer Study: External Selective Laser Trabeculoplasty for Treating Uncontrolled Open Angle Glaucoma|
- Intra Ocular Pressure values as a measure for treatment success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]a success is defined a decrease of >/= 20% in intra ocular pressure measured after treatment -compared to intra ocular pressure measured prior to treatment a relative success in an intra ocular pressure thet is lowered post treatment in less than 20% -compared to pre-treatment. failure is considered as an intra ocular pressure equal or higher than measured prior to treatment
- Use of supplementary treatment for lowering intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]success is defined as no need for suplemental medication for lowering intra ocular pressure ,complete failure is described as using the same amount or more of medication ,relative success in described as a need to use less hypotensive medications for lowering intraocular pressure after the procedure
|Study Start Date:||September 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: standart slt
gonioscopic selective laser trabeculoplasty
Device: standard slt
Nd:YAG LASER SLT gonioscopic laser treatment
Other Name: SLT laser
Experimental: external slt
perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots
Device: external slt
Nd:YAG LASER SLT perilimbal above trabecular meshwork 180 degrees ,100 lasering dots
Other Name: external SLT laser
glaucoma is the 2nd leading cause for blindness in the western world.at the time approximately 60 million people are diagnosed as glaucoma patients with an estimated rise of 30% in the next decade. glaucoma is defined as a progressive damage to the optic nerve ,followed by a damage to the visual field. high intraocular pressure (IOP) is considered a main risk factor.lowering IOP can be done in several ways ,including medication ,laser treatment and operations.
medical treatment is effective in most cases ,but requires high daily compliance,side effects and availability of medication in living areas.
laser trabeculoplasty treatment for reducing IOP is a first line treatment for patients with open angle glaucoma (OAG).with success rate of 70-90%, it can be done as an additive treatment or as a sole treatment.
SLT or "cold" laser is a non-invasive treatment in which short wave lengths are being transduced in short intervals ,through a gonioscopic lens to the area of filtering angle. thec wave length is specific to cells rich in melanin (located in the filtering angle). the mechanism of action is regeneration of cytokine surge -causing macrophages recruitment and breakage of inter-cell connections at the trabecular meshwork (filtering area) and allows rise in fluid shift. the treatment requires several lasering to areas at the surrounding the wave does not cause rise in tissue heat or scaring of tissue and can be repeated.among its disadvantages are reduction in affect during time,causing new elevation of IOP , potential peripheral anterior synechia (PAS), corneal erosion or oedema,requires experience in treating through gonioscopic lense.
previous reports in the literature regarding external low intensity laser (LIL)show less complication rate.
our study evaluates the use of external SLT by using a standard retinal laser machine ,with procedure performed on the outer sclera-above the trabecular meshwork with laser parameters similar to those used in retinal surgeries.
this is a prospective, randomized, comparative clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384149
|Assaf Harofhe Medical Center|
|Beer Yaakov, Israel, 70300|
|Ophthalmology Department ,Meir Medical Center|
|Kfar Saba, Israel, 44281|
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Study Chair:||Noa Gefen, Dr.||Meir Medical Center, Kfar Saba, Israel|
|Principal Investigator:||Michael Belkin, Prof.||Sheba Medical Center, Ramat Gan ,Israel|
|Principal Investigator:||Ehud Asia, Prof.||Meir Medical Center, Kfar Saba, Israel|
|Principal Investigator:||Audry masas-kaplan, Dr.||Assaf Harofhe Medical Center, Beer Yaakov, Israel|