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NCT01886456 Clinical Trial

IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01886456
Other study ID # 14.1.2013_KEK ZH 2012-0422
Secondary ID
Status Recruiting
Phase N/A
First received June 21, 2013
Last updated June 24, 2013
Start date February 2013
Est. completion date February 2017

Study information
Verified date June 2013
Source University of Zurich
Contact Gregor Jaggi, MD
Email gregor.jaggi@usz.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 210
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Laser trabeculoplasty

Locations
Country Name City State
Switzerland University Hospital Zurich, Ophthalmology Clinic Zurich ZH

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure 6 months after Intervention 6 months Yes
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