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IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

Primary Purpose

Open Angle Glaucoma,, Ocular Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Laser trabeculoplasty
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Zurich, Ophthalmology ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PLT

SLT

Arm Description

patients treated with patterned laser trabeculoplasty

patients treated with selective laser trabeculoplasty

Outcomes

Primary Outcome Measures

Intraocular pressure 6 months after Intervention

Secondary Outcome Measures

Full Information

First Posted
June 21, 2013
Last Updated
June 24, 2013
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01886456
Brief Title
IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma,, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLT
Arm Type
Experimental
Arm Description
patients treated with patterned laser trabeculoplasty
Arm Title
SLT
Arm Type
Active Comparator
Arm Description
patients treated with selective laser trabeculoplasty
Intervention Type
Device
Intervention Name(s)
Laser trabeculoplasty
Primary Outcome Measure Information:
Title
Intraocular pressure 6 months after Intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor Jaggi, MD
Email
gregor.jaggi@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Kniestedt, MD
Email
christoph.kniestedt@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Kniestedt, MD
Organizational Affiliation
University Hospital Zurich, Ophthalmology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Ophthalmology Clinic
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35943114
Citation
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.
Results Reference
derived

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IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

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