- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01363362
Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma (SLT/OBF)
December 17, 2012 updated by: Dr. Karin Pillunat, Technische Universität Dresden
Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saxony
-
Dresden, Saxony, Germany, 01307
- University Eye Clinic Dresden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- glaucoma patient
- over 18 years
- needs further intraocular pressure regulation
Exclusion Criteria:
- age under 18 years
- debilitated
- no glaucoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: glaucoma patients
Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction
|
360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT)
Time Frame: baseline and 3 month
|
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.)
|
baseline and 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Lutz E Pillunat, Prof. MD, University Eye Clinic Dresden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 27, 2011
First Submitted That Met QC Criteria
May 31, 2011
First Posted (Estimate)
June 1, 2011
Study Record Updates
Last Update Posted (Estimate)
December 18, 2012
Last Update Submitted That Met QC Criteria
December 17, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLT/OBF_EK 398122010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.