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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801658
First Posted: December 3, 2008
Last Update Posted: December 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
Information provided by:
University of Zurich
  Purpose
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.

Condition Intervention Phase
Glaucoma Device: selective Laser Trabeculoplasty (SLT) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • IOP lowering effect of SLT in a special patient group [ Time Frame: 1 day, 1 , 3, 6 , 12 months postoperative ]

Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: July 2009
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801658


Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Responsible Party: Prof. Dr. Dr. Jens Funk, University hospital zurich, eye clinic
ClinicalTrials.gov Identifier: NCT00801658     History of Changes
Other Study ID Numbers: FunkSLT
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: December 4, 2008
Last Verified: December 2008

Keywords provided by University of Zurich:
glaucoma
SLT
Laser treatment
IOP
glaucoma treated with eye drops but IOP not controlled

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions