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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801658
• Other study ID #: FunkSLT
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2008
• Last updated: December 3, 2008
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2008
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: University of Zurich
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• selective Laser Trabeculoplasty (SLT)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP lowering effect of SLT in a special patient group		1 day, 1 , 3, 6 , 12 months postoperative	No