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

This study is not yet open for participant recruitment.

Verified July 2011 by Meir Medical Center

Sponsor:

Information provided by:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT01384149

First received: May 16, 2011

Last updated: July 10, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2011

Last Updated Date

July 10, 2011

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01384149 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA

Official Title ^ICMJE

A Pioneer Study: External Selective Laser Trabeculoplasty for Treating Uncontrolled Open Angle Glaucoma

Brief Summary

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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Open Angle Glaucoma

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gefen Noa, Dr.

+972-9-747-2154

noatal1122@gmail.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01384149

Other Study ID Numbers ^ICMJE

meirslt2011

Has Data Monitoring Committee

Responsible Party

Dr. Gefen Noa, Meir Medical Hospital

Study Sponsor ^ICMJE

Meir Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Meir Medical Center

Verification Date

July 2011

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

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