Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma (SLT/OBF)
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Selective Laser Trabeculoplasty
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Selective Laser Trabeculoplasty, pulsatile ocular blood flow
Eligibility Criteria
Inclusion Criteria:
- glaucoma patient
- over 18 years
- needs further intraocular pressure regulation
Exclusion Criteria:
- age under 18 years
- debilitated
- no glaucoma
Sites / Locations
- University Eye Clinic Dresden
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
glaucoma patients
Arm Description
Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction
Outcomes
Primary Outcome Measures
Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)
Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.)
Secondary Outcome Measures
Full Information
NCT ID
NCT01363362
First Posted
May 27, 2011
Last Updated
December 17, 2012
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT01363362
Brief Title
Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma
Acronym
SLT/OBF
Official Title
Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.
Detailed Description
Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Selective Laser Trabeculoplasty, pulsatile ocular blood flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glaucoma patients
Arm Type
Experimental
Arm Description
Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction
Intervention Type
Procedure
Intervention Name(s)
Selective Laser Trabeculoplasty
Other Intervention Name(s)
Lasertrabeculoplasty
Intervention Description
360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ
Primary Outcome Measure Information:
Title
Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)
Description
Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.)
Time Frame
baseline and 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
glaucoma patient
over 18 years
needs further intraocular pressure regulation
Exclusion Criteria:
age under 18 years
debilitated
no glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lutz E Pillunat, Prof. MD
Organizational Affiliation
University Eye Clinic Dresden
Official's Role
Study Chair
Facility Information:
Facility Name
University Eye Clinic Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma
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