EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA (ETSG)
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
external slt
standard slt
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring intra ocular pressure, open angle glaucoma, selective laser trabeculoplasty, external laser treatment
Eligibility Criteria
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
Sites / Locations
- Assaf Harofhe Medical Center
- Ophthalmology Department ,Meir Medical Center
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standart slt
external slt
Arm Description
gonioscopic selective laser trabeculoplasty
perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots
Outcomes
Primary Outcome Measures
Intra Ocular Pressure values as a measure for treatment success
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
Secondary Outcome Measures
Use of supplementary treatment for lowering intraocular pressure
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01384149
Brief Title
EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA
Acronym
ETSG
Official Title
A Pioneer Study: External Selective Laser Trabeculoplasty for Treating Uncontrolled Open Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
intra ocular pressure, open angle glaucoma, selective laser trabeculoplasty, external laser treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standart slt
Arm Type
Active Comparator
Arm Description
gonioscopic selective laser trabeculoplasty
Arm Title
external slt
Arm Type
Experimental
Arm Description
perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots
Intervention Type
Device
Intervention Name(s)
external slt
Other Intervention Name(s)
external SLT laser
Intervention Description
Nd:YAG LASER SLT perilimbal above trabecular meshwork 180 degrees ,100 lasering dots
Intervention Type
Device
Intervention Name(s)
standard slt
Other Intervention Name(s)
SLT laser
Intervention Description
Nd:YAG LASER SLT gonioscopic laser treatment
Primary Outcome Measure Information:
Title
Intra Ocular Pressure values as a measure for treatment success
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Use of supplementary treatment for lowering intraocular pressure
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noa Gefen, Dr.
Organizational Affiliation
Meir Medical Center, Kfar Saba, Israel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Belkin, Prof.
Organizational Affiliation
Sheba Medical Center, Ramat Gan ,Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ehud Asia, Prof.
Organizational Affiliation
Meir Medical Center, Kfar Saba, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Audry masas-kaplan, Dr.
Organizational Affiliation
Assaf Harofhe Medical Center, Beer Yaakov, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofhe Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Ophthalmology Department ,Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16488940
Citation
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Results Reference
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11024415
Citation
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PubMed Identifier
17655930
Citation
Freeman EE, Munoz B, West SK, Jampel HD, Friedman DS. Glaucoma and quality of life: the Salisbury Eye Evaluation. Ophthalmology. 2008 Feb;115(2):233-8. doi: 10.1016/j.ophtha.2007.04.050. Epub 2007 Jul 26.
Results Reference
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PubMed Identifier
4856873
Citation
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PubMed Identifier
9818610
Citation
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Results Reference
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PubMed Identifier
20547951
Citation
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Results Reference
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PubMed Identifier
16865007
Citation
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derived
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EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA
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