NCT02679482

Brief Summary

The purpose of this study is to follow and describe the outcomes of patients after selective and pascal laser trabeculoplasty treatment for chronic open-angle glaucoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

February 6, 2016

Last Update Submit

February 13, 2016

Conditions

Glaucoma, Open-AngleGlaucoma, Primary Open AngleExfoliation GlaucomaGlaucoma, Pigmentary

Keywords

Primary Open Angle GlaucomaSelective Laser TrabeculoplastyPattern Scan Laser Trabeculoplasty

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    The eye pressure measured in millimeters of mercury, measure with Goldman tonometer at follow-up period

    Six months

Study Arms (2)

Selective laser trabeculoplasty (SLT)

Patients who underwent to Selective laser trabeculoplasty

Pattern laser trabeculoplasty (PLT)

Patients who underwent to Pattern laser trabeculoplasty

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Open-Angle Glaucoma with a non-optimal intraocular pressure control with topical/oral medications, who underwent to laser trabeculoplasty treatment, attending the Fundacion Oftalmológica Nacional between June 2014 and july 2016 on Bogotá-Colombia.

You may qualify if:

  • Subjects of either sex, aged ≥ 40 years
  • Best distant visual acuity, better than or equal to 20/200
  • Diagnosis of primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma, with open angles by Posner lens gonioscopy
  • Intraocular pressure ≥ 20 mmHg, with medical treatment, as monotherapy or combination therapy.
  • Previous computerized visual field within the six months previous performing trabeculoplasty
  • Patients who understand and sign the informed consent
  • Patient diagnosed with open-angle glaucoma who will undergo selective laser trabeculoplasty (SLT) with an amplitud of 360 degrees, or laser trabeculaplastia in pattern (PASCAL-Pattern Scan Laser) with an amplitud of 360 degrees. Made at initial session or in two 7 days separate sessions (each with session with an amplitude of180 degrees)

You may not qualify if:

  • Advanced loss on visual field within 10 degrees of central fixation in a previous 3 months visual field
  • Previous history of surgery for glaucoma management, except peripheral iridotomy
  • Corneal disease that does not allow the use of applanation tonometer nor an accurate measurement of intraocular pressure
  • Corneal disease which prevents adequate visualization of trabeculo by gonioscopy lens
  • Use of topical or systemic steroids
  • Concomitant participation in another study
  • Coexistence of other ocular pathology different than cataract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Oftalmológica Nacional

Bogotá, Bogota D.C., 110231, Colombia

RECRUITING

Related Publications (18)

  • Wang W, He M, Zhou M, Zhang X. Selective laser trabeculoplasty versus argon laser trabeculoplasty in patients with open-angle glaucoma: a systematic review and meta-analysis. PLoS One. 2013 Dec 19;8(12):e84270. doi: 10.1371/journal.pone.0084270. eCollection 2013.

    PMID: 24367649BACKGROUND

  • Wise JB, Witter SL. Argon laser therapy for open-angle glaucoma. A pilot study. Arch Ophthalmol. 1979 Feb;97(2):319-22. doi: 10.1001/archopht.1979.01020010165017. No abstract available.

    PMID: 575877BACKGROUND

  • Barkana Y, Belkin M. Selective laser trabeculoplasty. Surv Ophthalmol. 2007 Nov-Dec;52(6):634-54. doi: 10.1016/j.survophthal.2007.08.014.

    PMID: 18029271BACKGROUND

  • Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. doi: 10.1016/s0014-4835(05)80093-4.

    PMID: 7789416BACKGROUND

  • Sanghvi C, McLauchlan R, Delgado C, Young L, Charles SJ, Marcellino G, Stanga PE. Initial experience with the Pascal photocoagulator: a pilot study of 75 procedures. Br J Ophthalmol. 2008 Aug;92(8):1061-4. doi: 10.1136/bjo.2008.139568. Epub 2008 Jun 27.

    PMID: 18586905BACKGROUND

  • Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Ther Adv Chronic Dis. 2014 Jan;5(1):30-43. doi: 10.1177/2040622313511286.

    PMID: 24381726BACKGROUND

  • Buys YM. Economics of selective laser trabeculoplasty as primary therapy for glaucoma. Can J Ophthalmol. 2006 Aug;41(4):419-20. doi: 10.1016/S0008-4182(06)80001-3. No abstract available.

    PMID: 16883356BACKGROUND

  • Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.

    PMID: 21453963BACKGROUND

  • Samples JR, Singh K, Lin SC, Francis BA, Hodapp E, Jampel HD, Smith SD. Laser trabeculoplasty for open-angle glaucoma: a report by the american academy of ophthalmology. Ophthalmology. 2011 Nov;118(11):2296-302. doi: 10.1016/j.ophtha.2011.04.037. Epub 2011 Aug 17.

    PMID: 21849211BACKGROUND

  • Krasnov MM. [Laser puncture of the anterior chamber angle in glaucoma (a preliminary report)]. Vestn Oftalmol. 1972;3:27-31. No abstract available. Russian.

    PMID: 5078295BACKGROUND

  • Van Buskirk EM, Pond V, Rosenquist RC, Acott TS. Argon laser trabeculoplasty. Studies of mechanism of action. Ophthalmology. 1984 Sep;91(9):1005-10. doi: 10.1016/s0161-6420(84)34197-5.

    PMID: 6493712BACKGROUND

  • Alvarado JA, Alvarado RG, Yeh RF, Franse-Carman L, Marcellino GR, Brownstein MJ. A new insight into the cellular regulation of aqueous outflow: how trabecular meshwork endothelial cells drive a mechanism that regulates the permeability of Schlemm's canal endothelial cells. Br J Ophthalmol. 2005 Nov;89(11):1500-5. doi: 10.1136/bjo.2005.081307.

    PMID: 16234461BACKGROUND

  • Bradley JM, Anderssohn AM, Colvis CM, Parshley DE, Zhu XH, Ruddat MS, Samples JR, Acott TS. Mediation of laser trabeculoplasty-induced matrix metalloproteinase expression by IL-1beta and TNFalpha. Invest Ophthalmol Vis Sci. 2000 Feb;41(2):422-30.

    PMID: 10670472BACKGROUND

  • The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13.

    PMID: 2255512BACKGROUND

  • Bylsma SS, Samples JR, Acott TS, Van Buskirk EM. Trabecular cell division after argon laser trabeculoplasty. Arch Ophthalmol. 1988 Apr;106(4):544-7. doi: 10.1001/archopht.1988.01060130590044.

    PMID: 3355425BACKGROUND

  • Pham H, Mansberger S, Brandt JD, Damji K, Ramulu PY, Parrish RK. Argon laser trabeculoplasty versus selective laser trabeculoplasty. Surv Ophthalmol. 2008 Nov-Dec;53(6):641-6. doi: 10.1016/j.survophthal.2008.08.020.

    PMID: 19026324BACKGROUND

  • Zhao JC, Grosskreutz CL, Pasquale LR. Argon versus selective laser trabeculoplasty in the treatment of open angle glaucoma. Int Ophthalmol Clin. 2005 Fall;45(4):97-106. doi: 10.1097/01.iio.0000176370.01511.6e. No abstract available.

    PMID: 16199969BACKGROUND

  • Wang H, Cheng JW, Wei RL, Cai JP, Li Y, Ma XY. Meta-analysis of selective laser trabeculoplasty with argon laser trabeculoplasty in the treatment of open-angle glaucoma. Can J Ophthalmol. 2013 Jun;48(3):186-92. doi: 10.1016/j.jcjo.2013.01.001.

    PMID: 23769780BACKGROUND

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleExfoliation Syndrome

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Study Officials

  • Sandra Belalcazar, MD

    Fundacion Oftalmológica Nacional

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Carvajal

CONTACT

+57-311-856-4991crcarvajal@fon.org.co

Adriana Cerquera

CONTACT

+57-310-383-5075acerquera@fon.org.co

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2016

First Posted

February 10, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

CO(1)