Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
selective Laser Trabeculoplasty (SLT)
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, SLT, Laser treatment, IOP, glaucoma treated with eye drops but IOP not controlled
Eligibility Criteria
Inclusion criteria: Patients with
- primary open angle glaucoma (including normal tension glaucoma)
- pseudoexfoliation glaucoma
- pigment dispersion glaucoma
Exclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork
Sites / Locations
Outcomes
Primary Outcome Measures
IOP lowering effect of SLT in a special patient group
Secondary Outcome Measures
Full Information
NCT ID
NCT00801658
First Posted
December 2, 2008
Last Updated
December 3, 2008
Sponsor
University of Zurich
Collaborators
Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
1. Study Identification
Unique Protocol Identification Number
NCT00801658
Brief Title
Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
Collaborators
Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed.
Detailed Description
SLT (Selective Laser Trabeculoplasty) uses the Nd:YAG-Lasers (wavelength 532nm, Q-switched, frequency-doubled). Thanks to the low laser energy used and the short duration of treatment, only pigmented cells of the trabecular meshwork are targeted and selectively treated. Neighboring, non-pigmented cells and tissue are spared collateral and thermic damage, the architecture of the trabecular meshwork remains intact. The SLT procedure uses less than 1% of the energy of the ALT procedure with an extremely low pulsation duration.
Several studies confirm the effective IOD reduction of SLT and rate the procedure as an relatively safe and effective therapy for glaucoma. Also repeated use of the SLT procedure is considered as meaningful. Meanwhile the SLT procedure is used as primary and supplementary treatment of glaucoma and study confirmed that the SLT procedure was just as effective as administration of Latanoprost in reducing IOD in newly-diagnosed glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, SLT, Laser treatment, IOP, glaucoma treated with eye drops but IOP not controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
selective Laser Trabeculoplasty (SLT)
Primary Outcome Measure Information:
Title
IOP lowering effect of SLT in a special patient group
Time Frame
1 day, 1 , 3, 6 , 12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with
primary open angle glaucoma (including normal tension glaucoma)
pseudoexfoliation glaucoma
pigment dispersion glaucoma
Exclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
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