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IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by University of Zurich.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
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 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 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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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 |
Additional relevant MeSH terms:
|
Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension |
Vascular Diseases Cardiovascular Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 22, 2017