NCT01384149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

May 16, 2011

Last Update Submit

August 11, 2014

Conditions

Primary Open Angle Glaucoma

Keywords

intra ocular pressureopen angle glaucomaselective laser trabeculoplastyexternal laser treatment

Outcome Measures

Primary Outcomes (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

    6 months

Secondary Outcomes (1)

  • Use of supplementary treatment for lowering intraocular pressure

    6 months

Study Arms (2)

standart slt

ACTIVE COMPARATOR

gonioscopic selective laser trabeculoplasty

Device: standard slt

external slt

EXPERIMENTAL

perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots

Device: external slt

Interventions

external sltDEVICE

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

Also known as: external SLT laser
external slt
standard sltDEVICE

Nd:YAG LASER SLT gonioscopic laser treatment

Also known as: SLT laser
standart slt

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Assaf Harofhe Medical Center

Beer Yaakov, 70300, Israel

Location

Ophthalmology Department ,Meir Medical Center

Kfar Saba, 44281, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (12)

  • 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.

    PMID: 16488940BACKGROUND

  • 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.

    PMID: 11024415BACKGROUND

  • 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.

    PMID: 17655930BACKGROUND

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

    PMID: 4856873BACKGROUND

  • 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.

    PMID: 9818610BACKGROUND

  • 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.

    PMID: 20547951BACKGROUND

  • 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.

    PMID: 16865007BACKGROUND

  • 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.

    PMID: 17106360BACKGROUND

  • 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.

    PMID: 19514814BACKGROUND

  • 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.

    PMID: 18951425BACKGROUND

  • 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.

    PMID: 20554506BACKGROUND

  • 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.

    PMID: 35943114DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Noa Gefen, Dr.

    Meir Medical Center, Kfar Saba, Israel

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

June 28, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

IL(3)