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Primary Open Angle GlaucomaPhase 1ETSGNCT01384149

EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA

A Phase 1 study testing external slt and standard slt in people with Primary Open Angle Glaucoma, run by Meir Medical Center at 3 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Primary Open Angle Glaucoma
What is being tested?
external slt and standard slt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesIsrael
Study dates
Sep 2011to Jan 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

  • Assaf Harofhe Medical Center

    Beer Yaakov, 70300

  • Ophthalmology Department ,Meir Medical Center

    Kfar Saba, 44281

  • Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Being tested
external slt, standard slt
Keywords
intra ocular pressure, open angle glaucoma, selective laser trabeculoplasty, external laser treatment
Medical subject headings
Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • external sltDevice

    Also called external SLT laser

    Nd:YAG LASER SLT perilimbal above trabecular meshwork 180 degrees ,100 lasering dots

  • standard sltDevice

    Also called SLT laser

    Nd:YAG LASER SLT gonioscopic laser treatment

Study groups in NCT01384149
Study groupRoleWhat they receive
standart sltActive comparatorgonioscopic selective laser trabeculoplasty
Receives: Device: standard slt
external sltExperimentalperilimbal ,above trabecular meshwork 180 degrees ,100 laser dots
Receives: Device: external slt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (1)

  1. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01384149
Sponsor's protocol ID
meirslt2011
Acronym
ETSG
Status last verified
Aug 2014
First submitted
16 May 2011
Last updated
12 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16488940

  • 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.

    PubMed 11024415

  • 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.

    PubMed 17655930

  • Worthen DM, Wickham MG. Argon laser trabeculotomy. Trans Am Acad Ophthalmol Otolaryngol. 1974 Mar-Apr;78(2):OP371-5. No abstract available.

    PubMed 4856873

  • 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.

    PubMed 9818610

  • 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.

    PubMed 20547951

  • 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.

    PubMed 16865007

  • 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.

    PubMed 17106360

  • 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.

    PubMed 19514814

  • 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.

    PubMed 18951425

  • 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.

    PubMed 20554506

  • 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.

    PubMed 35943114

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing external slt and standard slt in people with Primary Open Angle Glaucoma, run by Meir Medical Center at 3 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra Ocular Pressure values as a measure for treatment success (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01384149, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.

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