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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
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

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

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

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

First Posted
December 2, 2008
Last Updated
December 3, 2008
Sponsor
University of Zurich
Collaborators
Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
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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

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Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)

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