IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01886456
First received: June 21, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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 Intervention
Open Angle Glaucoma,
Ocular Hypertension
Device: Laser trabeculoplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Intraocular pressure 6 months after Intervention [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: February 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLT
patients treated with patterned laser trabeculoplasty
Device: Laser trabeculoplasty
Active Comparator: SLT
patients treated with selective laser trabeculoplasty
Device: Laser trabeculoplasty

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01886456     History of Changes
Other Study ID Numbers: 14.1.2013_KEK ZH 2012-0422
Study First Received: June 21, 2013
Last Updated: June 24, 2013
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on October 20, 2014