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:
University of Zurich
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
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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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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 (Adult, Senior) |
| 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
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
| 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:
|
Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension |
Vascular Diseases Cardiovascular Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 26, 2016