The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity (SLT/ORA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Karin Pillunat, Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01247831
First received: November 23, 2010
Last updated: December 17, 2012
Last verified: December 2012

November 23, 2010
December 17, 2012
November 2010
August 2011   (final data collection date for primary outcome measure)
change in ocular rigidity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Is there a change in ocular rigidtiy (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trebeculoplasty?
Same as current
Complete list of historical versions of study NCT01247831 on ClinicalTrials.gov Archive Site
IOP reduction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Is there an effective IOP drop after SLT?
Same as current
Not Provided
Not Provided
 
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity

The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.

Ocular Rigidity (corneal hysteresis and corneal resistance factor) is measured with the Ocular Response Analyzer (Reichert) before and 4 weeks after SLT (Q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). The trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mJ.

The purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
"Primary Open Angle Glaucoma, Ocular Hypertension"
Procedure: Selective Laser Trabeculoplasty
100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser.
Other Names:
  • SLT
  • ORA
Active Comparator: glaucoma patients
All of the patients treated with SLT need further IOP reduction for control of their glaucoma.
Intervention: Procedure: Selective Laser Trabeculoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma

Exclusion Criteria:

other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01247831
SLT/ORA/1
No
Dr. Karin Pillunat, Dresden University of Technology
Technische Universität Dresden
Not Provided
Principal Investigator: Karin R Hornykewycz, MD University Eye Clinic Dresden
Technische Universität Dresden
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP