search
Back to results

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
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
May 16, 2011
Last Updated
August 11, 2014
Sponsor
Meir Medical Center
search

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
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
Results Reference
background
PubMed Identifier
11024415
Citation
The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9.
Results Reference
background
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
background
PubMed Identifier
4856873
Citation
Worthen DM, Wickham MG. Argon laser trabeculotomy. Trans Am Acad Ophthalmol Otolaryngol. 1974 Mar-Apr;78(2):OP371-5. No abstract available.
Results Reference
background
PubMed Identifier
9818610
Citation
Latina MA, Sibayan SA, Shin DH, Noecker RJ, Marcellino G. Q-switched 532-nm Nd:YAG laser trabeculoplasty (selective laser trabeculoplasty): a multicenter, pilot, clinical study. Ophthalmology. 1998 Nov;105(11):2082-8; discussion 2089-90. doi: 10.1016/S0161-6420(98)91129-0.
Results Reference
background
PubMed Identifier
20547951
Citation
Alvarado JA, Katz LJ, Trivedi S, Shifera AS. Monocyte modulation of aqueous outflow and recruitment to the trabecular meshwork following selective laser trabeculoplasty. Arch Ophthalmol. 2010 Jun;128(6):731-7. doi: 10.1001/archophthalmol.2010.85.
Results Reference
background
PubMed Identifier
16865007
Citation
Rachmiel R, Trope GE, Chipman ML, Gouws P, Buys YM. Laser trabeculoplasty trends with the introduction of new medical treatments and selective laser trabeculoplasty. J Glaucoma. 2006 Aug;15(4):306-9. doi: 10.1097/01.ijg.0000212233.11287.b3.
Results Reference
background
PubMed Identifier
17106360
Citation
Coleman AL, Yu F, Evans SJ. Use of gonioscopy in medicare beneficiaries before glaucoma surgery. J Glaucoma. 2006 Dec;15(6):486-93. doi: 10.1097/01.ijg.0000212287.62798.8f.
Results Reference
background
PubMed Identifier
19514814
Citation
Ivandic BT, Hoque NN, Ivandic T. Early diagnosis of ocular hypertension using a low-intensity laser irradiation test. Photomed Laser Surg. 2009 Aug;27(4):571-5. doi: 10.1089/pho.2008.2342.
Results Reference
background
PubMed Identifier
18951425
Citation
Framme C, Walter A, Prahs P, Theisen-Kunde D, Brinkmann R. Comparison of threshold irradiances and online dosimetry for selective retina treatment (SRT) in patients treated with 200 nanoseconds and 1.7 microseconds laser pulses. Lasers Surg Med. 2008 Nov;40(9):616-24. doi: 10.1002/lsm.20685.
Results Reference
background
PubMed Identifier
20554506
Citation
Klatt C, Saeger M, Oppermann T, Porksen E, Treumer F, Hillenkamp J, Fritzer E, Brinkmann R, Birngruber R, Roider J. Selective retina therapy for acute central serous chorioretinopathy. Br J Ophthalmol. 2011 Jan;95(1):83-8. doi: 10.1136/bjo.2009.178327. Epub 2010 Jun 15.
Results Reference
background
PubMed Identifier
35943114
Citation
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Results Reference
derived

Learn more about this trial

EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA

We'll reach out to this number within 24 hrs