Primary Open Angle Glaucoma Clinical Trial
Official title:
A Pioneer Study: External Selective Laser Trabeculoplasty for Treating Uncontrolled Open Angle Glaucoma
The purpose of this study is to evaluate the advantages and disadvantages of external selective laser trabeculoplasty (SLT) in treating open angle glaucoma,compared to traditional SLT.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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