Clinical trial NCT01384149: EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA
Official title: A Pioneer Study: External Selective Laser Trabeculoplasty for Treating Uncontrolled Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Open Angle Glaucoma
Keywords: intra ocular pressure
open angle glaucoma
selective laser trabeculoplasty
external laser treatment
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intra Ocular Pressure values as a measure for treatment success
timeFrame: 6 months
Secondary outcomes:
measure: Use of supplementary treatment for lowering intraocular pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Assaf Harofhe Medical Center
city: Kfar Saba
country: Israel
facility: Ophthalmology Department ,Meir Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Meir Medical Center, Kfar Saba, Israel
name: Noa Gefen, Dr.
role: STUDY_CHAIR
affiliation: Sheba Medical Center, Ramat Gan ,Israel
name: Michael Belkin, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center, Kfar Saba, Israel
name: Ehud Asia, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf Harofhe Medical Center, Beer Yaakov, Israel
name: Audry masas-kaplan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Worthen DM, Wickham MG. Argon laser trabeculotomy. Trans Am Acad Ophthalmol Otolaryngol. 1974 Mar-Apr;78(2):OP371-5. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.