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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01384149
First received: May 16, 2011
Last updated: August 11, 2014
Last verified: August 2014

May 16, 2011
August 11, 2014
September 2011
January 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01384149 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA
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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Open Angle Glaucoma
  • Device: external slt
    Nd:YAG LASER SLT perilimbal above trabecular meshwork 180 degrees ,100 lasering dots
    Other Name: external SLT laser
  • Device: standard slt
    Nd:YAG LASER SLT gonioscopic laser treatment
    Other Name: SLT laser
  • Active Comparator: standart slt
    gonioscopic selective laser trabeculoplasty
    Intervention: Device: standard slt
  • Experimental: external slt
    perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots
    Intervention: Device: external slt

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01384149
meirslt2011
No
Meir Medical Center
Meir Medical Center
Not Provided
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
Meir Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP