EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA (ETSG)

Clalit Health Services

Status and phase: Completed; Phase 1

Conditions: Primary Open Angle Glaucoma

Treatments: Device: standard slt; Device: external slt

Study type: Interventional

Funder types: Other

Identifiers

NCT01384149

meirslt2011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Open Angle Glaucoma
• clinical appearance of pigment at the angle
• angle assessed as >3 by a professional glaucoma expert
• IOP above target pressure under full anti-hypertensive treatment with a good compliance for treatment or IOP above target pressure and poor compliance to medical treatment due to: allergic reaction , side effects,physical inability etc.
• able to sign independently on an informed concent

Exclusion criteria

• pregnancy/breast feeding
• glaucoma not specified as primary open angle glaucoma
• sensitivity to on or more of the medications in the study
• current /past intraocular inflammation
• primary open angle glaucoma with out appearance of pigment at the angle
• s/p laser trabeculoplasty at treatment eye
• inability to sign an informed concent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

standart slt

Active Comparator group

Description:

gonioscopic selective laser trabeculoplasty

Treatment:

Device: standard slt

external slt

Experimental group

Description:

perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots

Treatment:

Device: external slt