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

August 11, 2014 updated by: Meir Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Yaakov, Israel, 70300
        • Assaf Harofhe Medical Center
      • Kfar Saba, Israel, 44281
        • Ophthalmology Department ,Meir Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standart slt
gonioscopic selective laser trabeculoplasty
Device: standard slt
Nd:YAG LASER SLT gonioscopic laser treatment
Other Names:
  • 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 Names:
  • external SLT laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra Ocular Pressure values as a measure for treatment success
Time Frame: 6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of supplementary treatment for lowering intraocular pressure
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • meirslt2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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