IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

June 24, 2013 updated by: University of Zurich

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Ophthalmology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure 6 months after Intervention
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Christoph Kniestedt, MD, University Hospital Zurich, Ophthalmology Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.1.2013_KEK ZH 2012-0422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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