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IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

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ClinicalTrials.gov Identifier: NCT01886456
Recruitment Status : Unknown
Verified June 2013 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : June 25, 2013
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.

Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.

  • Trial with medical device

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma, Ocular Hypertension Device: Laser trabeculoplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension
Study Start Date : February 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: PLT
patients treated with patterned laser trabeculoplasty
 Device: Laser trabeculoplasty
Active Comparator: SLT
patients treated with selective laser trabeculoplasty
 Device: Laser trabeculoplasty


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular pressure 6 months after Intervention [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) > 21 mm Hg
  • visible angle structures over 360° on gonioscopy
  • age = 18 years

Exclusion criteria:

  • Intraocular Inflammation
  • patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
  • monocle situation
  • anterior chamber lenses (incl. iris claw)
  • secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886456


Contacts
Contact: Gregor Jaggi, MD gregor.jaggi@usz.ch
Contact: Christoph Kniestedt, MD christoph.kniestedt@usz.ch

Locations
Switzerland
University Hospital Zurich, Ophthalmology Clinic Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Christoph Kniestedt, MD University Hospital Zurich, Ophthalmology Clinic
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01886456     History of Changes
Other Study ID Numbers: 14.1.2013_KEK ZH 2012-0422
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
 Vascular Diseases
Cardiovascular Diseases
Eye Diseases